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AzTrials

Rheumatoid ArthritisPhase 4NCT01878318

A Study of The Effect of RoActemra/Actemra (Tocilizumab) in Combination With Methotrexate on Articular Damage in The Hand in Patients With Moderate to Severe Rheumatoid Arthritis Who Have an Inadequate Response to Non-Biological DMARDs

A Phase 4 study testing methotrexate and tocilizumab [RoActemra/Actemra] in people with Rheumatoid Arthritis, run by Hoffmann-La Roche.

Withdrawn

Withdrawn. The study stopped before anyone enrolled.

Official record
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Trial summary

This open-label, single arm study will evaluate the effect of RoActemra/Actemra in combination with methotrexate on articular damage in the hand (synovitis/osteitis and erosions) in patients with moderate to severe rheumatoid arthritis who have an inadequate response to non-biological disease-modifying ante-rheumatic… Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Rheumatoid Arthritis
What is being tested?
methotrexate and tocilizumab [RoActemra/Actemra]
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
0 participants
Where
No sites listed yet
Study dates
Jun 2013to Jun 2015
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 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Adult patients, >/= 18 years of age
  • Diagnosis of rheumatoid arthritis according to ACR/EULAR classification (2010) of >/= 6 months duration
  • Active moderate to severe rheumatoid arthritis (DAS >/= 3.2)
  • Swollen joint count (SJC) >/= 6, tender joint count >/= 8
  • Synovitis in the dominant hand
  • Inadequate response to stable dose of a non-biological DMARD for at least 3 months
  • Oral corticosteroids must have been on stable dose for at least 25 out of 28 days before first dose of study drug
  • Patient on outpatient treatment

Who cannot join

  • Major surgery (including joint surgery) in the 8 weeks prior to screening, or planned major surgery within 6 months of randomization
  • Rheumatic autoimmune disease other than rheumatoid arthritis
  • American College of Rheumatology (ACR) functional class IV
  • History of or current inflammatory joint disease other than rheumatoid arthritis
  • Previous inadequate response to a biologic DMARD; prior biologic therapy for no longer than 1 month is allowed if discontinued for reasons of tolerability at least 6 months prior to study recruitment
  • Intra-articular or parenteral corticosteroids within 6 weeks prior to study start
Show all 14Show fewer
  • Inadequate hematologic, renal or liver function
  • Positive for hepatitis B, hepatitis C or HIV infection
  • Pregnant or lactating women
  • History of severe allergic reactions or anaphylaxis to human, humanized or mural monoclonal antibodies
  • Current infections or history of recurrent infections
  • History of or currently active primary or acquired immunodeficiency
  • Active tuberculosis requiring treatment in the previous 3 years
  • Body weight > 150 kg

About this study

Official title: Open Label Study to Describe the Effect of Tocilizumab in Combination With MTX in the Evolution of Articular Damage (Synovitis/Osteitis and Erosions) Evaluated by MRI in the Hand of Patients With Moderate to Severe Rheumatoid Arthritis (RA) and Inadequate Response to Non-biological DMARDs

This open-label, single arm study will evaluate the effect of RoActemra/Actemra in combination with methotrexate on articular damage in the hand (synovitis/osteitis and erosions) in patients with moderate to severe rheumatoid arthritis who have an inadequate response to non-biological disease-modifying ante-rheumatic drugs (DMARDs). Patients will receive RoActemra/Actemra 8 mg/kg intravenously every 4 weeks for 24 weeks.

Being tested
methotrexate, tocilizumab [RoActemra/Actemra]
Medical subject headings
Arthritis, Rheumatoid

What participants receive

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

  • methotrexateDrug

    stable dose

  • tocilizumab [RoActemra/Actemra]Drug

    8 mg/kg intravenously every 4 weeks, 24 weeks

Study groups in NCT01878318
Study groupRoleWhat they receive
RoActemra/ActemraExperimentalNot described
Receives: Drug: methotrexate; Drug: tocilizumab [RoActemra/Actemra]

What is being measured

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

  1. Change in extent and degree of synovitis in the hand assessed by MRI according to the OMERACT RAMRIS scale

    Measured: from baseline to Week 24

Secondary outcomes (10)

  1. Radiological changes in the hand according to the modified Sharp scale

    Measured: from baseline to Week 24

  2. Change in Ritchie articular index

    Measured: from baseline to Week 24

  3. Proportion of patients with American College of Rheumatology (ACR 20/50/70) response at Weeks 12 and 24

    Measured: Weeks 12 and 24

  4. Change in pain: Visual analogue scale (VAS)

    Measured: from baseline to Week 24

  5. Change in disability: Stanford Health Assessment Questionnaire

    Measured: from baseline to Week 24

  6. Change in FACIT-fatigue questionnaire

    Measured: from baseline to Week 24

  7. Change in disease activity: Disease activity score 28 - erythrocyte sedimentation rate (DAS28-ESR)

    Measured: from baseline to Week 28

  8. Change in C-reactive protein

    Measured: from baseline to Week 24

  9. Change in immunologic parameters: Rheumatic factor/anti-CCP

    Measured: from baseline to Week 24

  10. Safety: Incidence of adverse events

    Measured: approximately 2 years

Timeline

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

  1. First posted14 Jun 2013 (estimated)
  2. Study startJun 2013
  3. Primary completionJun 2015 (estimated)
  4. Study completionJun 2015 (estimated)

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
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
0 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01878318
Sponsor's protocol ID
ML28204
Status last verified
Nov 2016
First submitted
6 Jun 2013
Last updated
2 Nov 2016
Results posted
No

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing methotrexate and tocilizumab [RoActemra/Actemra] in people with Rheumatoid Arthritis, run by Hoffmann-La Roche.

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 8 inclusion and 14 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: withdrawn, as of the sponsor's last update on 2 Nov 2016. Status can change between updates, so confirm with the study contact before making plans.

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 was withdrawn before enrolling participants, so there are no results.

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?

Change in extent and degree of synovitis in the hand assessed by MRI according to the OMERACT RAMRIS scale (time frame: from baseline to Week 24). 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 NCT01878318.

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 2 Nov 2016.

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