Study of Iguratimod Plus Methotrexate Compared to Leflunomid Plus Methotrexate in Patients With Rheumatoid Arthritis

NCT02275299 | Unknown Phase 4

• 1 other identifier: Tranmod
• Study Type: interventional
• Target: 240
• Locations: 1 country
• Sites: 1

Brief 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).

Conditions

Rheumatoid Arthritis

Outcome Measures

Primary Outcomes (1)

• Percentage of patients with ACR 20 response and Change in Disease Activity as measured by the DAS28

  week 52

Secondary Outcomes (6)

• Change from baseline in modified Total Sharp Score (mTSS)

  week 52

• Percentage of patients with ACR 50 response and ACR70 response

  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)

  week 24, week 52

• Time to achieve the ACR20, ACR50 and ACR70

  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)

  week 12, week 24, week 40, week 52

Study Arms (2)

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

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

Drug: Leflunomide; Drug: Methotrexate

Interventions

Iguratimod DRUG

Iguratimod 25 mg/tablet, taken orally, 2 tablets/day (bid),52 weeks

Also known as: Iremod

Iguratimod and MTX combination

Leflunomide DRUG

Leflunomide 10 mg/tablet, taken orally, 2 tablets/day (bid),52 weeks

Leflunomide and MTX combination

Methotrexate DRUG

Methotrexate 2.5 mg/tablet, taken orally once a week, 4 tablets/week,52 weeks

Iguratimod and MTX combination; Leflunomide and MTX combination

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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
• 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

You may not qualify if:

• 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
• 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

Sponsors & Collaborators

• Jiangsu Simcere Pharmaceutical Co., Ltd.: lead

Study Sites (1)

Peking Union Medical College Hospital

Beijing, Beijing Municipality, 100032, China

RECRUITING

MeSH Terms

Conditions

Arthritis, Rheumatoid

Interventions

iguratimod; Leflunomide; Methotrexate

Condition Hierarchy (Ancestors)

Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Connective Tissue Diseases; Skin and Connective Tissue Diseases; Autoimmune Diseases; Immune System Diseases

Intervention Hierarchy (Ancestors)

Isoxazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Aminopterin; Pterins; Pteridines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring

Central Study Contacts

weihong zhao, doctor

CONTACT

+86(25) 8556 6666; zhaoweihong@simcere.com

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 23, 2014
• First Posted: October 27, 2014
• Study Start: September 1, 2013
• Primary Completion: February 1, 2016
• Study Completion: February 1, 2016
• Last Updated: October 27, 2014

Record last verified: 2014-10

Locations

CN (1)