Rheumatoid Arthritis (RA)Phase 4NCT03737708
A Study Comparing Biologics + Methotrexate With Biologics + Tacrolimus in Patients With Rheumatoid Arthritis (RA)
A Phase 4 study testing tacrolimus, methotrexate and adalimumab in people with Rheumatoid Arthritis (RA), run by Astellas Pharma Korea, Inc. at 10 sites in South Korea.
Trial summary
The purpose of this study is to compare the efficacy of Biologics + Methotrexate with Biologics + Tacrolimus measured by the disease activity score 28 (DAS28) erythrocyte sedimentation rate (ESR) and the American College of Rheumatology (ACR) scores. The study will also assess the safety of the combinations. Read more about this study
- Who is it for?
- Ages 19 to 75 years
- Conditions the study is for
- Rheumatoid Arthritis (RA)
- What is being tested?
- tacrolimus, methotrexate and adalimumab
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 21 participants
- Where
- 10 sitesSouth Korea
- Study dates
- 13 Feb 2019to 16 Jun 2020
- 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 19 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Subjects with rheumatoid arthritis (RA) diagnosed by the 2010 American College of Rheumatology/European League Against Rheumatism (ACR/EULAR).
- Subjects who have been treated with combination therapy of one of biologic agent (adalimumab, tocilizumab, or abatacept) + methotrexate (MTX) over 2 months prior to Visit 1.
- Disease Activity Score (DAS28) erythrocyte sedimentation rate (ESR) ≥ 3.2 at screening and baseline.
- Subject agrees not to participate in another interventional study while participating in the present study.
Who cannot join
- Subjects with a past history of allergic reaction to Investigational Product or Comparative Drug used in this study.
- Subjects who were given tacrolimus (TAC) within three months before participation in this study.
- Subjects who have been treated with combination therapy of one of biologic agent (adalimumab, tocilizumab, or abatacept) + MTX exceeds 3 months at Baseline.
- Subjects who were already taking 20 mg of MTX at Screening Period.
- Subjects who were given the prohibited concomitant medications prior to randomization.
- Subjects with a medical history of clinically significant blood, gastrointestinal, endocrine, lung, nerve, or brain diseases at screening.
Show all 27Show fewer
- Subjects with a medical history of clinically significant liver, kidney, or heart diseases:
- Liver disease: Aspartate Aminotransferase (AST) and Alanine aminotransferase (ALT) > 3 × upper limit of normal (ULN) at screening, viral infection, nonviral infection, and liver cirrhosis;
- Kidney disease: serum creatinine > 2.0 mg/dL at screening;
- Heart disease: heart failure of ≥ The New York Heart Association class 3, arrhythmia or ischemic heart disease requiring treatment, and QTc interval > 450 ms on Electrocardiogram (ECG) at screening;
- Subjects with a history of uncontrolled diabetes (glycosylated hemoglobin > 8.5%).
- Subjects with hyperkalemia or serum potassium level > ULN of site reference ranges at screening.
- Subjects with severe respiratory disease or chronic generalized infectious disease.
- Subject who have a history of chronic infection or severe or life-threatening infection within 24 weeks before the baseline visit.
- Subject who are known to be infected by Human Immunodeficiency Virus, Hepatitis B, or Hepatitis C.
- Subject has a history of active tuberculosis or latent tuberculosis infection without treatment.
- Subject with mental disorder uncontrolled by drugs.
- Subject with chronic diarrhea, ulcerative stomatitis, gastric ulcer, or ulcerative colitis.
- Subject with genetic disorders including galactose intolerance, Lapp lactase deficiency, or glucose-galactose malabsorption.
- Subject with maculopathy, retinal disorders, or clinically significant eye diseases that may lead to visual disorder.
- Subject with bone marrow disorder, leukopenia, and blood cell disorder such as severe anemia and thrombocytopenia.
- Subject with a history of major surgery within 12-weeks before screening.
- Subject who were diagnosed with malignant tumors within 5 years before screening or who need treatment for malignant tumors diagnosed in the past.
- Patients with basal cell and squamous cell carcinomas of the skin or carcinoma in situ of the cervix uteri that has been excised and cured, may be included on the study at the discretion of the investigator.
- Female subject who is positive for the serum pregnancy test at Visit 1 among a woman of childbearing potential (WOCBP) (menopausal is defined as amenorrhea for at least one year) or not surgically sterile, or is not willing to use appropriate contraception during the study. Female subject trying to become pregnant or is currently pregnant or breast feeding.
- Male subject who donates sperm during the treatment period and for at least 30 days whichever is longer after the final study drug administration.
- Male subject with a pregnant or breastfeeding partner(s) who do not agree to remain abstinent or use a condom for the duration of the pregnancy, or for the time partner is breastfeeding, throughout the study period and for 30 days whichever is longer after the final study drug administration.
Trial locations and contacts
10 sites in 1 country.
10 sites in 1 country
South Korea10 sites
Site KR82003
Daegu
Site KR82007
Daegu
Site KR82006
Daejeon
Site KR82002
Incheon
Site KR82009
Seongnam
Site KR82001
Seoul
Site KR82005
Seoul
Site KR82010
Seoul
Site KR82012
Seoul
Site KR82013
Suwon
About this study
Official title: Compare Efficacy and Safety Between Biologics + Methotrexate (MTX) vs Biologics + Tacrolimus (TAC) (Switched From Biologics + Methotrexate (MTX)) in the Patients With Rheumatoid Arthritis (RA): Randomized, Interventional, Open, Active Controlled, Parallel Group, Multicenter-designed, Phase 4 Clinical Trial
The purpose of this study is to compare the efficacy of Biologics + Methotrexate with Biologics + Tacrolimus measured by the disease activity score 28 (DAS28) erythrocyte sedimentation rate (ESR) and the American College of Rheumatology (ACR) scores. The study will also assess the safety of the combinations.
Read the detailed description
This study will include 4-weeks screening and a 12-week open-label treatment period.The participants in this study will visit the center five (5) times over the study period.
- Conditions
- Rheumatoid Arthritis (RA)
- Being tested
- tacrolimus, methotrexate, adalimumab, tocilizumab, abatacept
- Keywords
- tacrolimus, abatacept, Prograf, adalimumab, methotrexate, tocilizumab, FK506
- Medical subject headings
- Arthritis, Rheumatoid
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
tacrolimusDrug
Also called FK506, Prograf
Administered orally
methotrexateDrug
Administered orally
adalimumabBiological
Administered as subcutaneous injection
tocilizumabBiological
Administered by intravenous injection
abataceptBiological
Administered by intravenous injection
| Study group | Role | What they receive |
|---|---|---|
| tacrolimus + biologics | Experimental | Participants will receive tacrolimus daily for 12 weeks. In addition, each participant will be administered one of adalimumab, tocilizumab, or abatacept for 12 weeks. Receives: Drug: tacrolimus; Biological: adalimumab; Biological: tocilizumab; Biological: abatacept |
| methotrexate + biologics | Active comparator | Participants will receive methotrexate weekly for 12 weeks. In addition, each participant will be administered one of adalimumab, tocilizumab, or abatacept for 12 weeks. Receives: Drug: methotrexate; Biological: adalimumab; Biological: tocilizumab; Biological: abatacept |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in disease activity score 28 (DAS28) erythrocyte sedimentation rate score (ESR) score at 12 weeks
DAS28-ESR will be calculated using data from tender joint count (TJC) (28 joints), swollen joint count (SJC) (28 joints), ESR and Subject's Global Assessment of Arthritis (SGA) with the formula; DAS28- ESR = 0.56√(TJC) + 0.28√(SJC) + 0.70 ln ESR + 0.014 x SGA.
High disease activity: DAS28 score exceeding 5.1 Moderate disease activity: DAS28 score of exceeding 3.2 to 5.1 Low disease activity: DAS28 score of less than or equal to 3.2 If the DAS28 score is less than 2.6, the participant will be considered to be in DAS28 remission.
Measured: From baseline (week 1) to week 12
Secondary outcomes (14)
Disease activity score 28 (DAS28) erythrocyte sedimentation rate (ESR) rate score at 4 weeks
DAS28-ESR will be calculated using data from TJC (28 joints), SJC (28 joints), ESR and SGA with the formula; DAS28- ESR = 0.56√(TJC) + 0.28√(SJC) + 0.70 ln ESR + 0.014 x SGA.
High disease activity: DAS28 score exceeding 5.1 Moderate disease activity: DAS28 score of exceeding 3.2 to 5.1 Low disease activity: DAS28 score of less than or equal to 3.2 If the DAS28 score is less than 2.6, the participant will be considered to be in DAS28 remission.
Measured: At 4 weeks
DAS28 (ESR) score at 8 weeks
DAS28-ESR will be calculated using data from TJC (28 joints), SJC (28 joints), ESR and SGA with the formula; DAS28- ESR = 0.56√(TJC) + 0.28√(SJC) + 0.70 ln ESR + 0.014 x SGA.
High disease activity: DAS28 score exceeding 5.1 Moderate disease activity: DAS28 score of exceeding 3.2 to 5.1 Low disease activity: DAS28 score of less than or equal to 3.2 If the DAS28 score is less than 2.6, the participant will be considered to be in DAS28 remission.
Measured: At 8 weeks
DAS28 (ESR) score at 12 weeks
DAS28-ESR will be calculated using data from TJC (28 joints), SJC (28 joints), ESR and SGA with the formula; DAS28- ESR = 0.56√(TJC) + 0.28√(SJC) + 0.70 ln ESR + 0.014 x SGA.
High disease activity: DAS28 score exceeding 5.1 Moderate disease activity: DAS28 score of exceeding 3.2 to 5.1 Low disease activity: DAS28 score of less than or equal to 3.2 If the DAS28 score is less than 2.6, the participant will be considered to be in DAS28 remission.
Measured: At 12 weeks
Change in DAS28 (ESR) score at 4 weeks
DAS28-ESR will be calculated using data from TJC (28 joints), SJC (28 joints), ESR and SGA with the formula; DAS28- ESR = 0.56√(TJC) + 0.28√(SJC) + 0.70 ln ESR + 0.014 x SGA.
High disease activity: DAS28 score exceeding 5.1 Moderate disease activity: DAS28 score of exceeding 3.2 to 5.1 Low disease activity: DAS28 score of less than or equal to 3.2 If the DAS28 score is less than 2.6, the participant will be considered to be in DAS28 remission.
Measured: From baseline (week 1) to week 4
Change in DAS28 (ESR) score at 8 weeks
DAS28-ESR will be calculated using data from TJC (28 joints), SJC (28 joints), ESR and SGA with the formula; DAS28- ESR = 0.56√(TJC) + 0.28√(SJC) + 0.70 ln ESR + 0.014 x SGA.
High disease activity: DAS28 score exceeding 5.1 Moderate disease activity: DAS28 score of exceeding 3.2 to 5.1 Low disease activity: DAS28 score of less than or equal to 3.2 If the DAS28 score is less than 2.6, the participant will be considered to be in DAS28 remission.
Measured: From baseline (week 1) to week 8
ACR 20 response rate
Percent of participants with American College of Rheumatology (ACR) 20 response rate The ACR20 response requires that all criteria from (1) to (3) be met compared with Week 0 (baseline); (1), Tender Joint Count (TJC) >= 20% reduction; (2), Swollen Joint Count (SJC) >= 20% reduction;(3) >= 20% improvement in three or more of the following five parameters - [1] subject's assessment of pain, [2] Subject's Global Assessment of Arthritis (SGA), [3] Physician's Global Assessment of Arthritis (PGA), [4] health assessment questionnaire-disability index (HAQ-DI), [5] acute phase reactant (erythrocyte sedimentation rate (ESR)).
Measured: At 12 weeks
ACR50 response rate
Percent of participants with ACR50 response rate The ACR50 response indicates a 50% improvement in all criteria used in the ACR20 assessment.
Measured: At 12 weeks
ACR70 response rate
Percent of participants with ACR70 response rate The ACR70 response indicates a 70% improvement in all criteria used in the ACR70 assessment.
Measured: At 12 weeks
Safety assessed by Adverse Events (AEs)
An AE is any untoward medical occurrence in a subject, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of a medicinal product.
Measured: Up to 16 weeks
Safety assessed by incidence of serious adverse events (SAE)
Adverse Event (AE) is considered "serious" if the investigator or sponsor view any of the following outcomes: Death, life-threatening, persistent or significant disability/incapacity, congenital anomaly or birth defect, hospitalization, or medically important event.
Measured: Up to 16 weeks
Safety assessed by incidence of treatment emergent adverse events (TEAE)
Treatment Emergent Adverse Event (TEAE) is defined as any AE which starts, or worsens, after the first dose of study drug through 30 days after the last dose of study drug.
Measured: Up to 12 weeks
Number of participants with laboratory value abnormalities and/or adverse events (AEs)
Number of participants with potentially clinically significant laboratory values.
Measured: Up to 16 weeks
Number of participants with vital sign abnormalities and /or adverse events (AEs)
Number of participants with potentially clinically significant vital sign values.
Measured: Up to 16 weeks
Number of participants with physical exam abnormalities and/or adverse events (AEs)
Number of participants with potentially clinically significant physical exam values.
Measured: Up to 16 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Nov 2018
- Study start13 Feb 2019
- Primary completion16 Jun 2020
- Study completion16 Jun 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Rheumatoid Arthritis (RA)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- Masking
- None (open label)
- Enrolment
- 21 participants (actual)
Sponsor and investigators
- Lead sponsor
- Astellas Pharma Korea, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Medical Monitor, Study director, Astellas Pharma Korea, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03737708
- Sponsor's protocol ID
- 506-MA-3187
- Status last verified
- Oct 2024
- First submitted
- 8 Nov 2018
- Last updated
- 31 Oct 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Access to anonymized individual participant level data will not be provided for this trial. Further details on Astellas' data sharing policy can be found at https://www.clinicaltrials.astellas.com/transparency/.
Study at a glance
From the registry record, last updated by the sponsor on 31 Oct 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Compare Efficacy and Safety Between Biologics + Methotrexate (MTX) vs Biologics + Tacrolimus (TAC) (Switched From Biologics + Methotrexate (MTX)) in the Patients With Rheumatoid Arthritis (RA): Randomized, Interventional, Open, Active Controlled, Parallel Group, Multicenter-designed, Phase 4 Clinical Trial
- ClinicalTrials.gov ID
- NCT03737708
- Acronym / sponsor ID
- 506-MA-3187
- Conditions
- Rheumatoid Arthritis (RA)
- Keywords
- tacrolimus, abatacept, Prograf, adalimumab, methotrexate, tocilizumab, FK506
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 21 participants (actual)
- Lead sponsor
- Astellas Pharma Korea, Inc.Industry (pharma, biotech, devices)
- Study start
- 13 Feb 2019 (actual)
- Primary completion
- 16 Jun 2020 (actual)
- Study completion
- 16 Jun 2020 (actual)
- First posted
- 9 Nov 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to compare the efficacy of Biologics + Methotrexate with Biologics + Tacrolimus measured by the disease activity score 28 (DAS28) erythrocyte sedimentation rate (ESR) and the American College of Rheumatology (ACR) scores. The study will also assess the safety of the combinations.
Detailed description
This study will include 4-weeks screening and a 12-week open-label treatment period.The participants in this study will visit the center five (5) times over the study period.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| tacrolimus + biologics | Experimental | Drug: tacrolimus, Biological: adalimumab, Biological: tocilizumab, Biological: abataceptParticipants will receive tacrolimus daily for 12 weeks. In addition, each participant will be administered one of adalimumab, tocilizumab, or abatacept for 12 weeks. |
| methotrexate + biologics | Active comparator | Drug: methotrexate, Biological: adalimumab, Biological: tocilizumab, Biological: abataceptParticipants will receive methotrexate weekly for 12 weeks. In addition, each participant will be administered one of adalimumab, tocilizumab, or abatacept for 12 weeks. |
Who may qualify
- Ages
- 19 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Subjects with rheumatoid arthritis (RA) diagnosed by the 2010 American College of Rheumatology/European League Against Rheumatism (ACR/EULAR).
- Subjects who have been treated with combination therapy of one of biologic agent (adalimumab, tocilizumab, or abatacept) + methotrexate (MTX) over 2 months prior to Visit 1.
- Disease Activity Score (DAS28) erythrocyte sedimentation rate (ESR) ≥ 3.2 at screening and baseline.
- Subject agrees not to participate in another interventional study while participating in the present study.
Key exclusion criteria (27 listed)
- Subjects with a past history of allergic reaction to Investigational Product or Comparative Drug used in this study.
- Subjects who were given tacrolimus (TAC) within three months before participation in this study.
- Subjects who have been treated with combination therapy of one of biologic agent (adalimumab, tocilizumab, or abatacept) + MTX exceeds 3 months at Baseline.
- Subjects who were already taking 20 mg of MTX at Screening Period.
- Subjects who were given the prohibited concomitant medications prior to randomization.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| tacrolimusAlso: FK506, PrografAdministered orally | Drug | tacrolimus + biologics |
| methotrexateAdministered orally | Drug | methotrexate + biologics |
| adalimumabAdministered as subcutaneous injection | Biological | methotrexate + biologics, tacrolimus + biologics |
| tocilizumabAdministered by intravenous injection | Biological | methotrexate + biologics, tacrolimus + biologics |
| abataceptAdministered by intravenous injection | Biological | methotrexate + biologics, tacrolimus + biologics |
Primary outcome
Change in disease activity score 28 (DAS28) erythrocyte sedimentation rate score (ESR) score at 12 weeks
Time frame: From baseline (week 1) to week 12
DAS28-ESR will be calculated using data from tender joint count (TJC) (28 joints), swollen joint count (SJC) (28 joints), ESR and Subject's Global Assessment of Arthritis (SGA) with the formula; DAS28- ESR = 0.56√(TJC) + 0.28√(SJC) + 0.70 ln ESR + 0.014 x SGA. High disease activity: DAS28 score exceeding 5.1 Moderate disease activity: DAS28 score of exceeding 3.2 to 5.1 Low disease activity: DAS28 score of less than or equal to 3.2 If the DAS28 score is less than 2.6, the participant will be considered to be in DAS28 remission.
14 secondary outcomes
Disease activity score 28 (DAS28) erythrocyte sedimentation rate (ESR) rate score at 4 weeks
Time frame: At 4 weeks
DAS28 (ESR) score at 8 weeks
Time frame: At 8 weeks
DAS28 (ESR) score at 12 weeks
Time frame: At 12 weeks
Change in DAS28 (ESR) score at 4 weeks
Time frame: From baseline (week 1) to week 4
Change in DAS28 (ESR) score at 8 weeks
Time frame: From baseline (week 1) to week 8
ACR 20 response rate
Time frame: At 12 weeks
ACR50 response rate
Time frame: At 12 weeks
ACR70 response rate
Time frame: At 12 weeks
Safety assessed by Adverse Events (AEs)
Time frame: Up to 16 weeks
Safety assessed by incidence of serious adverse events (SAE)
Time frame: Up to 16 weeks
Safety assessed by incidence of treatment emergent adverse events (TEAE)
Time frame: Up to 12 weeks
Number of participants with laboratory value abnormalities and/or adverse events (AEs)
Time frame: Up to 16 weeks
Number of participants with vital sign abnormalities and /or adverse events (AEs)
Time frame: Up to 16 weeks
Number of participants with physical exam abnormalities and/or adverse events (AEs)
Time frame: Up to 16 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Oct 2024.
- Individual participant dataSharing planned: No. Access to anonymized individual participant level data will not be provided for this trial. Further details on Astellas' data sharing policy can be found at https://www.clinicaltrials.astellas.com/transparency/.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Medical Monitor study director
Astellas Pharma Korea, Inc.
10 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing tacrolimus, methotrexate and adalimumab in people with Rheumatoid Arthritis (RA), run by Astellas Pharma Korea, Inc. at 10 sites in South Korea.
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 4 inclusion and 27 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 31 Oct 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 10 sites in South Korea. 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?
Change in disease activity score 28 (DAS28) erythrocyte sedimentation rate score (ESR) score at 12 weeks (time frame: From baseline (week 1) to week 12). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 31 Oct 2024.