AzTrials
AzTrials

Rheumatic ArthritisPhase 4AcceleRAteNCT04485325

Capability of Tofacitinib or Etanercept to Accelerate Tapering of NSAID and Treat-to-target Guided De-escalation of Corticosteroids in RA Patients

A Phase 4 study testing Tofacitinib and Etanercept in people with Rheumatic Arthritis, run by Dr. Frank Behrens at 6 sites in Germany.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

Patients with active rheumatic arthritis (RA) and lack of efficacy of at least one csDMARD (Disease-modifying anti-rheumatic drug) treatment will be randomized to receive either Tofacitinib (TOFA) or etanercept (ETA). Read more about this study

Who is it for?
Ages 18 to 65 years
Conditions the study is for
Rheumatic Arthritis
What is being tested?
Tofacitinib and Etanercept
Could I receive a placebo?
No, everyone receives an active treatment
How many people
92 participants
Where
6 sitesGermany
Study dates
4 Nov 2019to 31 Mar 2024
Phase
Phase 4
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 65 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Patients with active RA and an inadequate response to up to two previous conventional synthetic Disease modifying anti-rheumatic drug (csDMARD) treatments (methotrexate (MTX), leflunomide (LEF),sulfasalazine (SSZ)) with or without ongoing csDMARD therapy
  • RA according to ACR classification criteria
  • Age 18 - 65 years
  • Active RA is defined as
  • DAS28 > 3.2 and
  • TJC ≥ 3 and SJC ≥ 3
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  • VAS-pain ≥ 60 mm (0-100 mm)
  • Accompanying CS treatment for RA with a stable dosage of ≥ 2mg/d and ≤ 10 mg/d 2 weeks prior to BL (not more than 30% of patients without CS)
  • Accompanying need of NSAID or analgesic treatment due to arthritis and in dosages not exceeding the maximum dose according to Summary of Product characteristics (SmPC)
  • If ongoing csDMARD treatment, stable treatment will be defined as either
  • MTX treatment with a dosage of ≥ 10 mg/week and ≤ 25 mg/week, continuously for at least 12 weeks prior to Screening (SCR) with a stable dose of MTX for at least 2 weeks prior to BL or
  • LEF treatment with a dosage between 10 to 20 mg/day, continuously for at least 12 weeks prior to SCR with a stable dose of LEF for at least 2 weeks prior to BL or
  • SSZ treatment with dosage between 1 to 3 g/day, continuously for at least 12 weeks prior to SCR with a stable dose of SSZ for at least 2 weeks prior to BL
  • Presence of documented negative results for testing of Hepatitis B and C
  • Completed SARS-CoV-2-immunisation as currently recommended by the Standing Committee of Vaccination
  • Written informed consent obtained prior to the initiation of any protocol-required procedures
  • Willingness to comply to study procedures and study protocol

Who cannot join

  • Previous use of Tofacitinib or other Janus-Kinase (JAK)-inhibitors
  • Previous use of Etanercept
  • Previous use of any biological agent for RA
  • which was stopped due to lack of efficacy
  • one previous use of biological stopped due to intolerance will be allowed
  • CS treatment with dosages >10 mg at BL
Show all 37Show fewer
  • Known hypersensitivity to any component of the study medication (TOFA, ETA, Celecoxib)
  • Previous use of Celecoxib as analgesic therapy which was stopped due to lack of efficacy or intolerance
  • Concomitant diseases with chronic pain syndrome or need of extended dosages or long-term treatment with the maximum dosages of NSAID/analgesics (according to SmPC) due to other concomitant diseases/pain symptoms in discretion of the treating physician Exclusion criteria related to general health
  • Patients with other chronic inflammatory articular disease or systemic autoimmune disease
  • Patients with active Tuberculosis (Tb) (evaluation of Tb according to local standards in clinical care)
  • Patients with latent Tb, that are not pre-treated for at least 1 month and planned to be treated 9 months in total with Isozid once a day
  • Any active infection, a history of recurrent clinically significant infections (e.g. human immune deficiency virus (HIV)), or a history of recurrent bacterial infections with encapsulated organisms
  • Primary or secondary immunodeficiency
  • Current malignancy or history of malignancies except adequately treated or excised basal cell or squamous cell carcinoma or cervical carcinoma in situ.
  • Patients of 50 years and older, if they have one or more cardiovascular risk factors (CVRF) defined as:
  • Current cigarette smoking,
  • Known diagnosis of hypertension,
  • HDL <40 mg/dl,
  • Diabetes mellitus,
  • History of coronary artery disease: history of revascularization procedure, coronary artery bypass grafting, myocardial infarction, cardiac arrest, unstable angina, acute coronary syndrome or
  • History of premature coronary heart disease or sudden death documented in first degree relatives (male relative before 55 years, female relative before 65 years)
  • Evidence of significant uncontrolled concomitant diseases or serious and/or uncontrolled diseases that are likely to interfere with the evaluation of the patient's safety and with the study outcome
  • History of a severe psychological illness or condition
  • Known hypersensitivity to sulfonamides
  • Active peptic ulceration or gastrointestinal (GI) bleeding
  • Patients who have experienced asthma, acute rhinitis, nasal polyps, angioneurotic oedema, urticaria or other allergic-type reactions after taking acetylsalicylic acid (aspirin) or other NSAIDs including Cyclooxigenase (COX)-2 inhibitors
  • Risk for or history of thrombotic events (e.g. pulmonary embolism or thrombosis) Severe hepatic dysfunction (serum albumin < 25 g/L or Child-Pugh score ≥ 10)
  • Patients with estimated creatinine clearance < 30 mL/min
  • Inflammatory bowel disease
  • Congestive heart failure (New York Heart Association (NYHA) II-IV)
  • Established ischaemic heart disease, peripheral arterial disease and/or cerebrovascular disease
  • Women lactating, pregnant, nursing or of childbearing potential with a positive pregnancy test
  • Males or females of reproductive potential not willing to use effective contraception (e.g. contraceptive pill, intrauterine device (IUD), physical barrier)
  • Alcohol, drug or chemical abuse Exclusion criteria related to prior treatments
  • Current participation in another interventional clinical trial or participation within the last 90 days Exclusion criteria related to formal aspects
  • Underage or incapable patients

Trial locations and contacts

6 sites in 1 country.

6 sites in 1 country

Germany6 sites

  • Charité Universitätsmedizin Berlin, Med. Klinik mit Schwerpunkt Rheumatologie und klinische Immunologie

    Berlin

  • Rheumatologische Schwerpunktpraxis im Ärztehaus am Walter-Schreiber-Platz

    Berlin

  • CIRI - Centrum für innovative Diagnostik & Therapie, Rheumatologie/ Immunologie GmbH

    Frankfurt

  • Katholische Kliniken Rhein-Ruhr, St. Elisabeth Gruppe GmbH, Rheumazentrum Ruhrgebiet

    Herne

  • Praxis Prof. Dr. Kellner

    München

  • Rheumazentrum Ratingen

    Ratingen

Other trials in Germany

About this study

Official title: Capability of Tofacitinib or Etanercept to Accelerate Clinical Relevant Tapering of Non-steroidal Anti-inflammatory Drugs (NSAID) and Treat-to-target Guided De-escalation of Corticosteroids in Patients With Active Rheumatoid Arthritis (RA) and an Inadequate Response to Previous csDMARD Therapy (AcceleRAte)

Patients with active rheumatic arthritis (RA) and lack of efficacy of at least one csDMARD (Disease-modifying anti-rheumatic drug) treatment will be randomized to receive either Tofacitinib (TOFA) or etanercept (ETA). The study will be separated into two parts: The capability to decrease and discontinue pain-reducing treatment with a NSAID (non-steroidal anti-inflammatory drug) over the first 12 weeks of treatment will be measured for primary outcome measured using a visual analogue scale (VAS) at week 12 compared to baseline between the two treatment groups.

Starting at week 12, the capability to taper corticosteroid (CS) treatment using a treat-to-target strategy, i.e. when at least low disease activity (LDA-DAS28) is achieved, will be measured in both groups.

Read the detailed description

In this clinical study, a design was chosen to reflect European standards recommended by EULAR for treatment of active RA by comparison of a Treat-to- target (T2T) approach in two treatment groups: Patients with active RA and lack of efficacy of at least one csDMARD treatment will be randomized to receive either TOFA or ETA. The study will be separated into two parts: The capability to decrease and discontinue pain-reducing treatment with a NSAID (Celecoxib, two times 200 mg as maximum standard dosage for RA) over the first 12 weeks of treatment will be measured for primary outcome. The proportion of patients with successful discontinuation of Celecoxib and significant and clinical relevant decrease of pain-levels measured using a visual analogue scale (VAS) with a reduction of at least 30% at week 12 compared to baseline will be compared between the two treatment groups.

Starting at week 12, the capability to taper CS treatment using a treat-to-target strategy, i.e. when at least low disease activity (LDA-DAS28) is achieved, will be measured in both groups. In addition to efficacy assessments (DAS28, ACR-response, SJC, TJC), patient reported outcomes, Quality of Life (QoL) measurements and patient satisfaction will be evaluated. Safety (severity and frequency of adverse events) will be evaluated over the 24-week treatment period.

Being tested
Tofacitinib, Etanercept
Keywords
treat-to-target, pain
Medical subject headings
Rheumatic Fever, Pain

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • TofacitinibDrug

    Also called TOFA, Xeljanz

    5 mg twice daily, p.o.

  • EtanerceptBiological

    Also called Enbrel, ETA

    50 mg once per week, s.c.

Study groups in NCT04485325
Study groupRoleWhat they receive
TofacitinibActive comparatorTofacitinib (Xeljanz®; 5 mg twice daily, p.o.)
Receives: Drug: Tofacitinib
EtanerceptActive comparatorEtanercept (Enbrel®; 50 mg once per week, s.c.)
Receives: Biological: Etanercept

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Discontinuation of Celecoxib treatment and clinically relevant improvement in pain

    Proportion of patients who can discontinue Celecoxib treatment and in whom clinically relevant improvement in pain levels are measured, defined as reduction in VAS pain of ≥ 30%

    Measured: Baseline to week 12

Secondary outcomes (145)

  1. Mean dosage of Celecoxib in patients

    Mean dosage of Celecoxib in patients

    Measured: at 12 weeks

  2. discontinuation of CS-treatment

    Proportion of patients with discontinuation of CS-treatment at week 24

    Measured: at week 24

  3. rescue treatment

    Proportion of patients who require rescue treatment at week 12

    Measured: at week 12

  4. Mean dosage of Corticosteroids (CS) in the patients who achieve Low Disease activity (LDA) in the two treatment groups

    Mean dosage of CS in the patients who achieve LDA at week 24 in the two treatment groups

    Measured: at week 24

  5. Mean dosage of Corticosteroids (CS)

    Mean dosage of CS at week 24 (W24)

    Measured: at week 24

  6. NSAID treatment

    Number of patients with NSAID treatment at W24

    Measured: at week 24

  7. re-started NSAID treatment

    Proportion of patients who re-started NSAID treatment after week 12 (W12) until W24

    Measured: week 12 to week 24

  8. Absolute pain levels

    Absolute pain levels measured by visual analogue scale (VAS). minimum is 0 mm, maximum is 100 mm whereas 0 is no pain and 100 is worst

    Measured: at week 2

  9. Absolute pain levels

    Absolute pain levels measured by visual analogue scale (VAS). minimum is 0 mm, maximum is 100 mm whereas 0 is no pain and 100 is worst

    Measured: at week 4

  10. Absolute pain levels

    Absolute pain levels measured by visual analogue scale (VAS). minimum is 0 mm, maximum is 100 mm whereas 0 is no pain and 100 is worst

    Measured: at week 8

  11. Absolute pain levels

    Absolute pain levels measured by visual analogue scale (VAS). minimum is 0 mm, maximum is 100 mm whereas 0 is no pain and 100 is worst

    Measured: at week 12

  12. Absolute pain levels

    Absolute pain levels measured by visual analogue scale (VAS). minimum is 0 mm, maximum is 100 mm whereas 0 is no pain and 100 is worst

    Measured: at week 16

  13. Absolute pain levels

    Absolute pain levels measured by visual analogue scale (VAS). minimum is 0 mm, maximum is 100 mm whereas 0 is no pain and 100 is worst

    Measured: at week 20

  14. Absolute pain levels

    Absolute pain levels measured by visual analogue scale (VAS). minimum is 0 mm, maximum is 100 mm whereas 0 is no pain and 100 is worst

    Measured: at week 24

  15. relative (percent) pain levels

    relative (percent) pain levels measured by visual analogue scale (VAS). minimum is 0 mm, maximum is 100 mm whereas 0 is no pain and 100 is worst

    Measured: at week 2

  16. relative (percent) pain levels

    relative (percent) pain levels measured by visual analogue scale (VAS). minimum is 0 mm, maximum is 100 mm whereas 0 is no pain and 100 is worst

    Measured: at week 4

  17. relative (percent) pain levels

    relative (percent) pain levels measured by visual analogue scale (VAS). minimum is 0 mm, maximum is 100 mm whereas 0 is no pain and 100 is worst

    Measured: at week 8

  18. relative (percent) pain levels

    relative (percent) pain levels measured by visual analogue scale (VAS). minimum is 0 mm, maximum is 100 mm whereas 0 is no pain and 100 is worst

    Measured: at week 12

  19. relative (percent) pain levels

    relative (percent) pain levels measured by visual analogue scale (VAS). minimum is 0 mm, maximum is 100 mm whereas 0 is no pain and 100 is worst

    Measured: at week 16

  20. relative (percent) pain levels

    relative (percent) pain levels measured by visual analogue scale (VAS). minimum is 0 mm, maximum is 100 mm whereas 0 is no pain and 100 is worst

    Measured: at week 20

  21. relative (percent) pain levels

    relative (percent) pain levels measured by visual analogue scale (VAS). minimum is 0 mm, maximum is 100 mm whereas 0 is no pain and 100 is worst

    Measured: at week 24

  22. Change in pain levels

    Change in pain levels measured by visual analogue scale (VAS) compared to BL. minimum is 0 mm, maximum is 100 mm whereas 0 is no pain and 100 is worst

    Measured: at week 2

  23. Change in pain levels

    Change in pain levels visual analogue scale (VAS) compared to BL. minimum is 0 mm, maximum is 100 mm whereas 0 is no pain and 100 is worst

    Measured: at week 4

  24. Change in pain levels

    Change in pain levels visual analogue scale (VAS) compared to BL. minimum is 0 mm, maximum is 100 mm whereas 0 is no pain and 100 is worst

    Measured: at week 8

  25. Change in pain levels

    Change in pain levels visual analogue scale (VAS) compared to BL. minimum is 0 mm, maximum is 100 mm whereas 0 is no pain and 100 is worst

    Measured: at week 12

  26. Change in pain levels

    Change in pain levels visual analogue scale (VAS) compared to BL. minimum is 0 mm, maximum is 100 mm whereas 0 is no pain and 100 is worst

    Measured: at week 16

  27. Change in pain levels

    Change in pain levels visual analogue scale (VAS) compared to BL. minimum is 0 mm, maximum is 100 mm whereas 0 is no pain and 100 is worst

    Measured: at week 20

  28. Change in pain levels

    Change in pain levels visual analogue scale (VAS) compared to BL. minimum is 0 mm, maximum is 100 mm whereas 0 is no pain and 100 is worst

    Measured: at week 24

  29. Determination of flares

    Determination of flares (measured by FLARE questionnaire) between week 12 and week 24

    Measured: between week 12 and week 24

  30. Proportion of LDA

    Proportion of patients who achieve LDA (Disease Activity Score 28 (DAS28) calculated by Erythrocyte sediment rate (ESR) (DAS28 (ESR) ≤ 3.2)

    Measured: at week 4

  31. Proportion of LDA

    Proportion of patients who achieve LDA (Disease Activity Score 28 (DAS28) calculated by Erythrocyte sediment rate (ESR) (DAS28 (ESR) ≤ 3.2)

    Measured: at week 12

  32. Proportion of LDA

    Proportion of patients who achieve LDA (Disease Activity Score 28 (DAS28) calculated by Erythrocyte sediment rate (ESR) (DAS28 (ESR) ≤ 3.2)

    Measured: at week 16

  33. Proportion of LDA

    Proportion of patients who achieve LDA (Disease Activity Score 28 (DAS28) calculated by Erythrocyte sediment rate (ESR) (DAS28 (ESR) ≤ 3.2)

    Measured: at week 20

  34. Proportion of LDA

    Proportion of patients who achieve LDA (Disease Activity Score 28 (DAS28) calculated by Erythrocyte sediment rate (ESR) (DAS28 (ESR) ≤ 3.2)

    Measured: at week 24

  35. Proportion of DAS remission

    Proportion of patients who achieve DASremission (Disease Activity Score 28 (DAS28) calculated by Erythrocyte sediment rate (ESR) DAS28 (ESR) ≤ 2.6)

    Measured: at week 4

  36. Proportion of DAS remission

    Proportion of patients who achieve DASremission (Disease Activity Score 28 (DAS28) calculated by Erythrocyte sediment rate (ESR) DAS28 (ESR) ≤ 2.6)

    Measured: at week 12

  37. Proportion of DAS remission

    Proportion of patients who achieve DASremission (Disease Activity Score 28 (DAS28) calculated by Erythrocyte sediment rate (ESR) DAS28 (ESR) ≤ 2.6)

    Measured: at week 16

  38. Proportion of DAS remission

    Proportion of patients who achieve DASremission (Disease Activity Score 28 (DAS28) calculated by Erythrocyte sediment rate (ESR) DAS28 (ESR) ≤ 2.6)

    Measured: at week 20

  39. Proportion of DAS remission

    Proportion of patients who achieve DASremission (Disease Activity Score 28 (DAS28) calculated by Erythrocyte sediment rate (ESR) DAS28 (ESR) ≤ 2.6)

    Measured: at week 24

  40. Proportion of ACR20 response

    Proportion of patients who achieve ACR20 response - measure based on American College of Rheumatology (ACR) criteria improvement of at least 20%

    Measured: at week 4

  41. Proportion of ACR20 response

    Proportion of patients who achieve ACR20 response - measure based on American College of Rheumatology (ACR) criteria improvement of at least 20%

    Measured: at week 12

  42. Proportion of ACR20 response

    Proportion of patients who achieve ACR20 response - measure based on American College of Rheumatology (ACR) criteria improvement of at least 20%

    Measured: at week 16

  43. Proportion of ACR20 response

    Proportion of patients who achieve ACR20 response - measure based on American College of Rheumatology (ACR) criteria improvement of at least 20%

    Measured: at week 20

  44. Proportion of ACR20 response

    Proportion of patients who achieve ACR20 response - measure based on American College of Rheumatology (ACR) criteria improvement of at least 20%

    Measured: at week 24

  45. Proportion of ACR 50 response

    Proportion of patients who achieve ACR50 response - measure based on American College of Rheumatology (ACR) criteria improvement of at least 50%

    Measured: at week 4

  46. Proportion of ACR 50 response

    Proportion of patients who achieve ACR50 response - measure based on American College of Rheumatology (ACR) criteria improvement of at least 50%

    Measured: at week 12

  47. Proportion of ACR 50 response

    Proportion of patients who achieve ACR50 response - measure based on American College of Rheumatology (ACR) criteria improvement of at least 50%

    Measured: at week 16

  48. Proportion of ACR 50 response

    Proportion of patients who achieve ACR50 response - measure based on American College of Rheumatology (ACR) criteria improvement of at least 50%

    Measured: at week 20

  49. Proportion of ACR 50 response

    Proportion of patients who achieve ACR50 response - measure based on American College of Rheumatology (ACR) criteria improvement of at least 50%

    Measured: at week 24

  50. Proportion of ACR 70 response

    Proportion of patients who achieve ACR70 response - measure based on American College of Rheumatology (ACR) criteria improvement of at least 70%

    Measured: at week 4

  51. Proportion of ACR 70 response

    Proportion of patients who achieve ACR70 response - measure based on American College of Rheumatology (ACR) criteria improvement of at least 70%

    Measured: at week 12

  52. Proportion of ACR 70 response

    Proportion of patients who achieve ACR70 response - measure based on American College of Rheumatology (ACR) criteria improvement of at least 70%

    Measured: at week 16

  53. Proportion of ACR 70 response

    Proportion of patients who achieve ACR70 response - measure based on American College of Rheumatology (ACR) criteria improvement of at least 70%

    Measured: at week 20

  54. Proportion of ACR 70 response

    Proportion of patients who achieve ACR70 response - measure based on American College of Rheumatology (ACR) criteria improvement of at least 70%

    Measured: at week 24

  55. Changes in ACR core set

    Changes in ACR core set

    Measured: at baseline

  56. Changes in ACR core set

    Changes in ACR core set

    Measured: at week 4

  57. Changes in ACR core set

    Changes in ACR core set

    Measured: at week 12

  58. Changes in ACR core set

    Changes in ACR core set

    Measured: at week 16

  59. Changes in ACR core set

    Changes in ACR core set

    Measured: at week 20

  60. Changes in ACR core set

    Changes in ACR core set change

    Measured: at week 24

  61. DAS28 (ESR)

    DAS28 (ESR) change compared to BL

    Measured: at baseline

  62. DAS28 (ESR)

    DAS28 (ESR) change compared to BL

    Measured: at week 4

  63. DAS28 (ESR)

    DAS28 (ESR) change compared to BL

    Measured: at week 12

  64. DAS28 (ESR)

    DAS28 (ESR) change compared to BL

    Measured: at week 16

  65. DAS28 (ESR)

    DAS28 (ESR) change compared to BL

    Measured: at week 20

  66. DAS28 (ESR)

    DAS28 (ESR) change compared to BL

    Measured: at week 24

  67. SJC (66),

    Swollen joint count (66 joints) change compared to BL

    Measured: at baseline

  68. SJC (66),

    Swollen joint count (66 joints) change compared to BL

    Measured: at week 4

  69. SJC (66),

    Swollen joint count (66 joints) change compared to BL

    Measured: at week 12

  70. SJC (66),

    Swollen joint count (66 joints) change compared to BL

    Measured: at week 16

  71. SJC (66),

    Swollen joint count (66 joints) change compared to BL

    Measured: at week 20

  72. SJC (66),

    Swollen joint count (SJC) (66 joints) change compared to BL

    Measured: at week 24

  73. TJC (68)

    tender joint count (TJC) - 68 joints change compared to BL

    Measured: at baseline

  74. TJC (68)

    tender joint count (TJC) - 68 joints change compared to BL

    Measured: at week 4

  75. TJC (68)

    tender joint count (TJC) - 68 joints change compared to BL

    Measured: at week 12

  76. TJC (68)

    tender joint count (TJC) - 68 joints change compared to BL

    Measured: at week 16

  77. TJC (68)

    tender joint count (TJC) - 68 joints change compared to BL

    Measured: at week 20

  78. TJC (68)

    tender joint count (TJC) - 68 joints change compared to BL

    Measured: at week 24

  79. Quality of Life: SF36 (36 items short form health survey)

    Quality of Life: SF36 scores

    Measured: at baseline

  80. Quality of Life: SF36 (36 items short form health survey)

    Quality of Life: SF36 scores.SF36 is a 36 items short form health survey and consists of eight scaled scores, which are the weighted sums of the questions in their section. Each scale is directly transformed into a 0-100 scale on the assumption that each question carries equal weight. The lower the score the more disability. The higher the score the less disability i.e., a score of zero is equivalent to maximum disability and a score of 100 is equivalent to no disability.

    Measured: at week 4

  81. Change in Quality of Life: SF36 (36 items short form health survey)

    Quality of Life: SF36 change to BL. SF36 is a 36 items short form health survey and consists of eight scaled scores, which are the weighted sums of the questions in their section. Each scale is directly transformed into a 0-100 scale on the assumption that each question carries equal weight. The lower the score the more disability. The higher the score the less disability i.e., a score of zero is equivalent to maximum disability and a score of 100 is equivalent to no disability.

    Measured: at week 4

  82. Quality of Life: SF36 (36 items short form health survey)

    Quality of Life: SF36 scores. SF36 is a 36 items short form health survey and consists of eight scaled scores, which are the weighted sums of the questions in their section. Each scale is directly transformed into a 0-100 scale on the assumption that each question carries equal weight. The lower the score the more disability. The higher the score the less disability i.e., a score of zero is equivalent to maximum disability and a score of 100 is equivalent to no disability.

    Measured: at week 12

  83. Change in Quality of Life: SF36 (36 items short form health survey)

    Quality of Life: SF36 change to BL. SF36 is a 36 items short form health survey and consists of eight scaled scores, which are the weighted sums of the questions in their section. Each scale is directly transformed into a 0-100 scale on the assumption that each question carries equal weight. The lower the score the more disability. The higher the score the less disability i.e., a score of zero is equivalent to maximum disability and a score of 100 is equivalent to no disability.

    Measured: at week 12

  84. Quality of Life: SF36 (36 items short form health survey)

    Quality of Life: SF36 scores. SF36 is a 36 items short form health survey and consists of eight scaled scores, which are the weighted sums of the questions in their section. Each scale is directly transformed into a 0-100 scale on the assumption that each question carries equal weight. The lower the score the more disability. The higher the score the less disability i.e., a score of zero is equivalent to maximum disability and a score of 100 is equivalent to no disability.

    Measured: at week 16

  85. Change in Quality of Life: SF36 (36 items short form health survey)

    Quality of Life: SF36 change to BL. SF36 is a 36 items short form health survey and consists of eight scaled scores, which are the weighted sums of the questions in their section. Each scale is directly transformed into a 0-100 scale on the assumption that each question carries equal weight. The lower the score the more disability. The higher the score the less disability i.e., a score of zero is equivalent to maximum disability and a score of 100 is equivalent to no disability.

    Measured: at week 16

  86. Quality of Life: SF36 (36 items short form health survey)

    Quality of Life: SF36 scores. SF36 is a 36 items short form health survey and consists of eight scaled scores, which are the weighted sums of the questions in their section. Each scale is directly transformed into a 0-100 scale on the assumption that each question carries equal weight. The lower the score the more disability. The higher the score the less disability i.e., a score of zero is equivalent to maximum disability and a score of 100 is equivalent to no disability.

    Measured: at week 20

  87. Change in Quality of Life: SF36 (36 items short form health survey)

    Quality of Life: SF36 change to BL. SF36 is a 36 items short form health survey and consists of eight scaled scores, which are the weighted sums of the questions in their section. Each scale is directly transformed into a 0-100 scale on the assumption that each question carries equal weight. The lower the score the more disability. The higher the score the less disability i.e., a score of zero is equivalent to maximum disability and a score of 100 is equivalent to no disability.

    Measured: at week 20

  88. Quality of Life: SF36 (36 items short form health survey)

    Quality of Life: SF36 scores. SF36 is a 36 items short form health survey and consists of eight scaled scores, which are the weighted sums of the questions in their section. Each scale is directly transformed into a 0-100 scale on the assumption that each question carries equal weight. The lower the score the more disability. The higher the score the less disability i.e., a score of zero is equivalent to maximum disability and a score of 100 is equivalent to no disability.

    Measured: at week 24

  89. Change in Quality of Life: SF36 (36 items short form health survey)

    Quality of Life: SF36 change to BL. SF36 is a 36 items short form health survey and consists of eight scaled scores, which are the weighted sums of the questions in their section. Each scale is directly transformed into a 0-100 scale on the assumption that each question carries equal weight. The lower the score the more disability. The higher the score the less disability i.e., a score of zero is equivalent to maximum disability and a score of 100 is equivalent to no disability.

    Measured: at week 24

  90. Quality of Life HAQ-DI (health assessment questionnaire - disability index)

    Quality of Life HAQ-DI scores The HAQ-DI is a health assessment questionnaire - disability index that consists of 8 subcategories. For each the single scales range from 0 (no difficulty) to 3 (unable to do).

    Measured: at baseline

  91. Quality of Life HAQ-DI (health assessment questionnaire - disability index)

    Quality of Life HAQ-DI scores. The HAQ-DI is a health assessment questionnaire - disability index that consists of 8 subcategories. For each the single scales range from 0 (no difficulty) to 3 (unable to do).

    Measured: at week 4

  92. Change in Quality of Life HAQ-DI (health assessment questionnaire - disability index)

    Quality of Life HAQ-DI change to BL. The HAQ-DI is a health assessment questionnaire - disability index that consists of 8 subcategories. For each the single scales range from 0 (no difficulty) to 3 (unable to do).

    Measured: at week 4

  93. Quality of Life HAQ-DI (health assessment questionnaire - disability index)

    Quality of Life HAQ-DI scores. The HAQ-DI is a health assessment questionnaire - disability index that consists of 8 subcategories. For each the single scales range from 0 (no difficulty) to 3 (unable to do).

    Measured: at week 12

  94. Change of Quality of Life HAQ-DI (health assessment questionnaire - disability index)

    Quality of Life HAQ-DI change to BL. The HAQ-DI is a health assessment questionnaire - disability index that consists of 8 subcategories. For each the single scales range from 0 (no difficulty) to 3 (unable to do).

    Measured: at week 12

  95. Quality of Life HAQ-DI (health assessment questionnaire - disability index)

    Quality of Life HAQ-DI scores. The HAQ-DI is a health assessment questionnaire - disability index that consists of 8 subcategories. For each the single scales range from 0 (no difficulty) to 3 (unable to do).

    Measured: at week 16

  96. Change of Quality of Life HAQ-DI (health assessment questionnaire - disability index)

    Quality of Life HAQ-DI change to BL. The HAQ-DI is a health assessment questionnaire - disability index that consists of 8 subcategories. For each the single scales range from 0 (no difficulty) to 3 (unable to do).

    Measured: at week 16

  97. Quality of Life HAQ-DI (health assessment questionnaire - disability index)

    Quality of Life HAQ-DI scores.The HAQ-DI is a health assessment questionnaire - disability index that consists of 8 subcategories. For each the single scales range from 0 (no difficulty) to 3 (unable to do).

    Measured: at week 20

  98. Change of Quality of Life HAQ-DI (health assessment questionnaire - disability index)

    Quality of Life HAQ-DI change to BL. The HAQ-DI is a health assessment questionnaire - disability index that consists of 8 subcategories. For each the single scales range from 0 (no difficulty) to 3 (unable to do).

    Measured: at week 20

  99. Quality of Life HAQ-DI (health assessment questionnaire - disability index)

    Quality of Life HAQ-DI scores. The HAQ-DI is a health assessment questionnaire - disability index that consists of 8 subcategories. For each the single scales range from 0 (no difficulty) to 3 (unable to do).

    Measured: at week 24

  100. Change of Quality of Life HAQ-DI (health assessment questionnaire - disability index)

    Quality of Life HAQ-DI change to BL. The HAQ-DI is a health assessment questionnaire - disability index that consists of 8 subcategories. For each the single scales range from 0 (no difficulty) to 3 (unable to do).

    Measured: at week 24

  101. Correlation of SF36 and HAQ-DI results

    Correlation of SF36 and HAQ-DI results. The HAQ-DI is a health assessment questionnaire - disability index that consists of 8 subcategories. For each the single scales range from 0 (no difficulty) to 3 (unable to do). SF36 is a 36 items short form health survey and consists of eight scaled scores, which are the weighted sums of the questions in their section. Each scale is directly transformed into a 0-100 scale on the assumption that each question carries equal weight. The lower the score the more disability. The higher the score the less disability i.e., a score of zero is equivalent to maximum disability and a score of 100 is equivalent to no disability.

    Measured: through study completion, an average of 24 weeks

  102. Treatment satisfaction: TSQM-14 scores

    Treatment Satisfaction Questionnaire for Medication (TSQM-14) scores. The TSQM items are answered on 5- or 7-point Likert type scale and cover four domains: effectiveness; side effects; convenience and global satisfaction. A score can be obtained for each domain by summing of the corresponding items transformed on a 0-100 scale; higher values indicate higher satisfaction, better perceived effectiveness, lower burden associated to side-effects, better convenience.

    Measured: at week 4

  103. Treatment satisfaction: TSQM-14 scores

    Treatment Satisfaction Questionnaire for Medication (TSQM-14) scores. The TSQM items are answered on 5- or 7-point Likert type scale and cover four domains: effectiveness; side effects; convenience and global satisfaction. A score can be obtained for each domain by summing of the corresponding items transformed on a 0-100 scale; higher values indicate higher satisfaction, better perceived effectiveness, lower burden associated to side-effects, better convenience.

    Measured: at week 12

  104. Treatment satisfaction: TSQM-14 scores

    Treatment Satisfaction Questionnaire for Medication (TSQM-14) scores. The TSQM items are answered on 5- or 7-point Likert type scale and cover four domains: effectiveness; side effects; convenience and global satisfaction. A score can be obtained for each domain by summing of the corresponding items transformed on a 0-100 scale; higher values indicate higher satisfaction, better perceived effectiveness, lower burden associated to side-effects, better convenience.

    Measured: at week 16

  105. Treatment satisfaction: TSQM-14 scores

    Treatment Satisfaction Questionnaire for Medication (TSQM-14) scores. The TSQM items are answered on 5- or 7-point Likert type scale and cover four domains: effectiveness; side effects; convenience and global satisfaction. A score can be obtained for each domain by summing of the corresponding items transformed on a 0-100 scale; higher values indicate higher satisfaction, better perceived effectiveness, lower burden associated to side-effects, better convenience.

    Measured: at week 24

  106. Patient's expectation on treatment

    Patient's expectation on treatment asked and documented as free text

    Measured: at baseline

  107. Patient's expectation on treatment

    Patient's expectation on treatment asked and documented as free text

    Measured: at week 12

  108. Patient's expectation on treatment

    Patient's expectation on treatment asked and documented as free text

    Measured: at week 24

  109. Correlation of TSQM-14 results and patient's expectation on treatment

    Correlation of TSQM-14 results and patient's expectation on treatment

    Measured: through study completion, an average of 24 weeks

  110. drug accountability

    Evaluation of results of treatment adherence (drug accountability) using patient diary

    Measured: at week 4

  111. drug accountability

    Evaluation of results of treatment adherence (drug accountability) using patient diary

    Measured: at week 12

  112. drug accountability

    Evaluation of results of treatment adherence (drug accountability) using patient diary

    Measured: at week 16

  113. drug accountability

    Evaluation of results of treatment adherence (drug accountability) using patient diary

    Measured: at week 20

  114. drug accountability

    Evaluation of results of treatment adherence (drug accountability) using patient diary

    Measured: at week 24

  115. eGFR (estimated glomerular filtration rate)

    eGFR value

    Measured: at baseline

  116. eGFR (estimated glomerular filtration rate)

    eGFR value

    Measured: at week 4

  117. change in eGFR (estimated glomerular filtration rate)

    eGFR change to BL

    Measured: at week 4

  118. eGFR (estimated glomerular filtration rate)

    eGFR value

    Measured: at week 12

  119. change in eGFR (estimated glomerular filtration rate)

    eGFR change to BL

    Measured: at week 12

  120. change in eGFR (estimated glomerular filtration rate)

    eGFR change to BL

    Measured: at week 16

  121. eGFR (estimated glomerular filtration rate)

    eGFR value

    Measured: at week 16

  122. change in eGFR (estimated glomerular filtration rate)

    eGFR change to BL

    Measured: at week 20

  123. eGFR (estimated glomerular filtration rate)

    eGFR value

    Measured: at week 24

  124. change in eGFR (estimated glomerular filtration rate)

    eGFR change to BL

    Measured: at week 24

  125. blood pressure (mmHg)

    blood pressure (mmHg) Systolic or Diastolic Blood Pressure

    Measured: at baseline

  126. blood pressure (mmHg)

    blood pressure (mmHg) Systolic or Diastolic Blood Pressure

    Measured: at week 4

  127. change in blood pressure (mmHg)

    blood pressure (mmHg) Systolic or Diastolic Blood Pressure change to BL

    Measured: at week 4

  128. blood pressure (mmHg)

    blood pressure (mmHg) Systolic or Diastolic Blood Pressure

    Measured: at week 12

  129. change in blood pressure (mmHg)

    blood pressure (mmHg) Systolic or Diastolic Blood Pressure change to BL

    Measured: at week 12

  130. blood pressure (mmHg)

    blood pressure (mmHg) Systolic or Diastolic Blood Pressure

    Measured: at week 16

  131. change in blood pressure (mmHg)

    blood pressure (mmHg) Systolic or Diastolic Blood Pressure change to BL

    Measured: at week 16

  132. blood pressure (mmHg)

    blood pressure (mmHg) Systolic or Diastolic Blood Pressure

    Measured: at week 20

  133. change in blood pressure (mmHg)

    blood pressure (mmHg) Systolic or Diastolic Blood Pressure change to BL

    Measured: at week 20

  134. blood pressure (mmHg)

    blood pressure (mmHg) Systolic or Diastolic Blood Pressure

    Measured: at week 24

  135. change in blood pressure (mmHg)

    blood pressure (mmHg) Systolic or Diastolic Blood Pressure change to BL

    Measured: at week 24

  136. pain characteristics measured by QST (quantitative sensory testing)

    Correlation of pain characteristics measured by QST, VAS pain and pain relief

    Measured: at Baseline

  137. pain characteristics measured by QST (quantitative sensory testing)

    Correlation of pain characteristics measured by QST, VAS pain and pain relief

    Measured: at week 4

  138. pain characteristics measured by QST (quantitative sensory testing)

    Correlation of pain characteristics measured by QST, VAS pain and pain relief

    Measured: at week 8

  139. pain characteristics measured by QST (quantitative sensory testing)

    Correlation of pain characteristics measured by QST, VAS pain and pain relief

    Measured: at week 12

  140. pain characteristics measured by QST (quantitative sensory testing)

    Correlation of pain characteristics measured by QST, VAS pain and pain relief

    Measured: at week 24

  141. adverse events (AEs)

    Documentation of type, frequency and seriousness of adverse events (AEs)

    Measured: through study completion, an average of 24 weeks

  142. Infections

    Incidence rates of serious infection events (SIEs),

    Measured: through study completion, an average of 24 weeks

  143. Documentation of all lab abnormalities

    incidence rates of lab abnormalities

    Measured: through study completion, an average of 24 weeks

  144. Cardiovascular events

    incidence rates of cardio vascular events

    Measured: through study completion, an average of 24 weeks

  145. Malignencies

    incidence rates of malignancies

    Measured: through study completion, an average of 24 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted24 Jul 2020
  2. Study start4 Nov 2019
  3. Primary completion31 Mar 2024
  4. Study completion31 Mar 2024

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 4
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Model description
two arm, randomized, open-label, parallel group
Masking
None (open label)
Enrolment
92 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04485325
Sponsor's protocol ID
TMP-0731-2018
Acronym
AcceleRAte
Status last verified
Aug 2024
First submitted
30 Apr 2020
Last updated
28 Aug 2024
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing Tofacitinib and Etanercept in people with Rheumatic Arthritis, run by Dr. Frank Behrens at 6 sites in Germany.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 17 inclusion and 37 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 28 Aug 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 6 sites in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Discontinuation of Celecoxib treatment and clinically relevant improvement in pain (time frame: Baseline to week 12). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04485325.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Aug 2024.

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