Rheumatoid ArthritisPhase 4NCT02275299
Study of Iguratimod Plus Methotrexate Compared to Leflunomid Plus Methotrexate in Patients With Rheumatoid Arthritis
A Phase 4 study testing Iguratimod, Leflunomide and Methotrexate in people with Rheumatoid Arthritis, run by Jiangsu Simcere Pharmaceutical Co., Ltd. at 1 site in China.
Trial summary
This study is intended to evaluate the efficacy and safety of Iguratimod Plus Methotrexate Compared to Leflunomid Plus Methotrexate in patients with active Rheumatoid Arthritis (RA). Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Rheumatoid Arthritis
- What is being tested?
- Iguratimod, Leflunomide and Methotrexate
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 240 participants
- Where
- 1 siteChina
- Study dates
- Sep 2013to Feb 2016
- 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 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Subjects with a diagnosis of RA according to the diagnostic criteria of the American College of Rheumatology (ACR) (revised in 1987)
- Rheumatoid Arthritis for more than 3 months from the time of the initial diagnosis
- Functional Class II-III
- Subjects have active RA at the time of screening
- Subjects with inadequate response to biologics should have a washout period before the initiation of study. For etanercept, washout period should be 2-week, and 8-week for infliximab and adalimumab.
- For firstly diagnostic RA patients, the disease activity should be moderate to severe, with DAS28>3.2
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- Must have at least 4 tender joints (66 join count) and 8 swollen joints( 68 join count) at screening and baseline
- Has a C-reactive protein ≥ 10 mg/L(or 1.0 mg/dL) OR Erythrocyte Sedimentation Rate (ESR) ≥ 28 mm/hr
- Must have a negative Pregnancy test and use adequate method of contraception throughout the trial
- Written informed consent
Who cannot join
- Preceding treatment with DMARDs, immunosuppressants (cyclophosphamide, cyclosporine, azathioprine, etc.), or Tripterygium within 4 weeks prior to study entry
- Subjects have been treated with iguratimod or leflunomide combined with MTX before screening.
- Subjects combined with other autoimmune disease, such as systemic lupus erythematosus (SLE), mixed connective tissue disease (MCTD), scleriasis and polymyositis, except for Sjögren syndrome.
- Chest x-ray abnormalities, such as tuberculosis, interstitial pulmonary fibrosis, etc.
- ALT >1.5×ULN, AST >1.5×ULN, Cr >135umol/L, total bilirubin>1.5×ULN
- WBC<4×109/L，HGB<85g/L，PLT<100×109/L
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- Subjects with serious cardiovascular, renal, hematologic, endocrine diseases or malignant
- Women of Pregnant or breastfeeding, and male or female with recent plan to conception
- Subjects with immunodeficiency, uncontrolled infection and active gastrointestinal disease
- Allergic to any of the study drugs
- History of alcoholism
- Subjects with mental illness
- Subjects receiving live vaccines recently
- Subjects participating in other clinical study within 3 months prior to study entry
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Peking Union Medical College Hospital
Beijing, Beijing Municipality, 100032
Fengchun Zhang, doctor, +86（10）6915 6114, zhangfccra@yahoo.com.cn
About this study
Official title: A Randomized, Double-blind Study to Evaluate the Efficacy and Safety of Iguratimod or Leflunomide in Combination With Methotrexate in Patients With Active Rheumatoid Arthritis
This study is intended to evaluate the efficacy and safety of Iguratimod Plus Methotrexate Compared to Leflunomid Plus Methotrexate in patients with active Rheumatoid Arthritis (RA).
- Conditions
- Rheumatoid Arthritis
- Being tested
- Iguratimod, Leflunomide, Methotrexate
- Medical subject headings
- Arthritis, Rheumatoid
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
IguratimodDrug
Also called Iremod
Iguratimod 25 mg/tablet, taken orally, 2 tablets/day (bid),52 weeks
LeflunomideDrug
Leflunomide 10 mg/tablet, taken orally, 2 tablets/day (bid),52 weeks
MethotrexateDrug
Methotrexate 2.5 mg/tablet, taken orally once a week, 4 tablets/week,52 weeks
| Study group | Role | What they receive |
|---|---|---|
| Iguratimod and MTX combination | Experimental | Drug:Iguratimod 25 mg/tablet, taken orally, 2 tablets/day (bid) Drug:MTX 2.5 mg/tablet, taken orally once a week, 4 tablets/week Receives: Drug: Iguratimod; Drug: Methotrexate |
| Leflunomide and MTX combination | Active comparator | Drug: Leflunomide 10 mg/tablet, taken orally, 2 tablets/day (bid) Drug: Methotrexate 2.5 mg/tablet, taken orally once a week, 4 tablets/week Receives: Drug: Leflunomide; Drug: Methotrexate |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of patients with ACR 20 response and Change in Disease Activity as measured by the DAS28
Measured: week 52
Secondary outcomes (6)
Change from baseline in modified Total Sharp Score (mTSS)
Measured: week 52
Percentage of patients with ACR 50 response and ACR70 response
Measured: week 24,week 52
Change from baseline in number of swollen and tender joins, Erythrocyte sedimentation rate (ESR) ,C-reactive protein (CRP),anti-citrullinated-protein antibody (ACPA) and heumatoid factor(RF)
Measured: week 24, week 52
Time to achieve the ACR20, ACR50 and ACR70
Measured: week 12, week 24, week 40, week 52
Percentage of patients with Simplified Disease Activity Index (SDAI) ≤ 3.3 and change from baseline in Health Assessment Questionnaire (HAQ)
Measured: week 12, week 24, week 40, week 52
Incidence of adverse events
Measured: up to 52 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Oct 2014 (estimated)
- Study startSep 2013
- Primary completionFeb 2016 (estimated)
- Study completionFeb 2016 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Rheumatoid ArthritisStudies of the same condition, open and under way.
- More trials run by Jiangsu Simcere Pharmaceutical Co., Ltd.The sponsor's other registered studies.
- 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
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 240 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Jiangsu Simcere Pharmaceutical Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02275299
- Sponsor's protocol ID
- Tranmod
- Status last verified
- Oct 2014
- First submitted
- 23 Oct 2014
- Last updated
- 27 Oct 2014
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Oct 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Double-blind Study to Evaluate the Efficacy and Safety of Iguratimod or Leflunomide in Combination With Methotrexate in Patients With Active Rheumatoid Arthritis
- ClinicalTrials.gov ID
- NCT02275299
- Acronym / sponsor ID
- Tranmod
- Conditions
- Rheumatoid Arthritis
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 240 participants (estimated)
- Lead sponsor
- Jiangsu Simcere Pharmaceutical Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- Sep 2013
- Primary completion
- Feb 2016 (estimated)
- Study completion
- Feb 2016 (estimated)
- First posted
- 27 Oct 2014 (estimated)
- 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.
This study is intended to evaluate the efficacy and safety of Iguratimod Plus Methotrexate Compared to Leflunomid Plus Methotrexate in patients with active Rheumatoid Arthritis (RA).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Iguratimod and MTX combination | Experimental | Drug: Iguratimod, Drug: MethotrexateDrug:Iguratimod 25 mg/tablet, taken orally, 2 tablets/day (bid) Drug:MTX 2.5 mg/tablet, taken orally once a week, 4 tablets/week |
| Leflunomide and MTX combination | Active comparator | Drug: Leflunomide, Drug: MethotrexateDrug: Leflunomide 10 mg/tablet, taken orally, 2 tablets/day (bid) Drug: Methotrexate 2.5 mg/tablet, taken orally once a week, 4 tablets/week |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- Subjects with a diagnosis of RA according to the diagnostic criteria of the American College of Rheumatology (ACR) (revised in 1987)
- Rheumatoid Arthritis for more than 3 months from the time of the initial diagnosis
- Functional Class II-III
- Subjects have active RA at the time of screening
- Subjects with inadequate response to biologics should have a washout period before the initiation of study. For etanercept, washout period should be 2-week, and 8-week for infliximab and adalimumab.
Key exclusion criteria (14 listed)
- Preceding treatment with DMARDs, immunosuppressants (cyclophosphamide, cyclosporine, azathioprine, etc.), or Tripterygium within 4 weeks prior to study entry
- Subjects have been treated with iguratimod or leflunomide combined with MTX before screening.
- Subjects combined with other autoimmune disease, such as systemic lupus erythematosus (SLE), mixed connective tissue disease (MCTD), scleriasis and polymyositis, except for Sjögren syndrome.
- Chest x-ray abnormalities, such as tuberculosis, interstitial pulmonary fibrosis, etc.
- ALT >1.5×ULN, AST >1.5×ULN, Cr >135umol/L, total bilirubin>1.5×ULN
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 |
|---|---|---|
| IguratimodAlso: IremodIguratimod 25 mg/tablet, taken orally, 2 tablets/day (bid),52 weeks | Drug | Iguratimod and MTX combination |
| LeflunomideLeflunomide 10 mg/tablet, taken orally, 2 tablets/day (bid),52 weeks | Drug | Leflunomide and MTX combination |
| MethotrexateMethotrexate 2.5 mg/tablet, taken orally once a week, 4 tablets/week,52 weeks | Drug | Iguratimod and MTX combination, Leflunomide and MTX combination |
Primary outcome
Percentage of patients with ACR 20 response and Change in Disease Activity as measured by the DAS28
Time frame: week 52
6 secondary outcomes
Change from baseline in modified Total Sharp Score (mTSS)
Time frame: week 52
Percentage of patients with ACR 50 response and ACR70 response
Time frame: week 24,week 52
Change from baseline in number of swollen and tender joins, Erythrocyte sedimentation rate (ESR) ,C-reactive protein (CRP),anti-citrullinated-protein antibody (ACPA) and heumatoid factor(RF)
Time frame: week 24, week 52
Time to achieve the ACR20, ACR50 and ACR70
Time frame: week 12, week 24, week 40, week 52
Percentage of patients with Simplified Disease Activity Index (SDAI) ≤ 3.3 and change from baseline in Health Assessment Questionnaire (HAQ)
Time frame: week 12, week 24, week 40, week 52
Incidence of adverse events
Time frame: up to 52 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Oct 2014.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Iguratimod, Leflunomide and Methotrexate in people with Rheumatoid Arthritis, run by Jiangsu Simcere Pharmaceutical Co., Ltd. at 1 site in China.
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 10 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: status not confirmed, as of the sponsor's last update on 27 Oct 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact weihong zhao, doctor (+86(25) 8556 6666 ext. 8701, zhaoweihong@simcere.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Percentage of patients with ACR 20 response and Change in Disease Activity as measured by the DAS28 (time frame: week 52). 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 27 Oct 2014.