Status:
COMPLETED
A Clinical Trial to Study the Effects of Revamilast in Patients With Rheumatoid Arthritis
Lead Sponsor:
Glenmark Pharmaceuticals Ltd. India
Collaborating Sponsors:
Glenmark Pharmaceuticals S.A.
Conditions:
Rheumatoid Arthritis
Eligibility:
All Genders
18-65 years
Phase:
PHASE2
Brief Summary
Rheumatoid arthritis (RA) is a systemic autoimmune and chronic inflammatory disease that causes progressive damage to joints of the body, affecting the functional capacity. Effective management of pat...
Eligibility Criteria
Inclusion
- Male or female ≥18 to ≤ 65 years of age
- Documented history of RA; diagnosed according to the revised American College of Rheumatology criteria (ACR)
- Active RA defined as patients with:
- 6 swollen joint counts
- 6 tender/painful joint counts, and
- At least two of the three following criteria:
- Rheumatoid Factor positive or Anti CCP positive
- CRP ≥1.2 times upper limit of normal reference range or ESR \>28 mm/hr
- Morning stiffness lasting \>45 min for at least last4 weeks
- DAS-28 CRP values ≥ 4.5 at screening (visit 1)
- Patients must have been on stable (15 mg to 25 mg) or maximum tolerated dose of MTX for at least 12 weeks prior to screening
- The patient's written informed consent to participate in the study
- Female participants must have a negative serum pregnancy test at screening visit.
- Males must agree to use barrier while on study medication and for 90 days after taking the last dose of study medication
- Must meet the following laboratory criteria:
- Hemoglobin ≥ 9 g/dL
- White blood cell (WBC) count; ≥3.0 X 109/L
- Platelet count ≥ 100,000 /L (100 X 109/L)
- Serum creatinine \<1.5 mg/dL (or 133mol/L)
- Total bilirubin \<2.0 mg/dL
- AST \& ALT\<1.5 times upper limit of normal
Exclusion
- Diagnosis of RA prior to 16 years of age (Juvenile RA)
- Non-degenerative joint diseases or other joint diseases that could interfere with the evaluation of RA
- Patients with any other autoimmune rheumatic disorders with the exception of Sjogren's syndrome.
- Patients with first degree relative with immune deficiency
- History of infection with human immunodeficiency virus and/or active hepatitis B or C
- Severe disabling arthritis leaving the patient eligible for surgical intervention, or incapacitated and prostrated patients
- Patients with a history of drug or alcohol abuse or chronic smoking
- Uncontrolled diabetes mellitus
- Concurrent diseases that might interfere with the conduct of the study,
- ECG abnormalities judged by the investigator to be clinically significant
- History of using any other test drug, one month before the beginning of this trial
- Women who are pregnant or breast-feeding or on hormonal therapy
- Patients who in the Investigator's opinion might not be suitable for the study.
- Patients with a life expectancy of less than 1 year
Key Trial Info
Start Date :
September 1 2011
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2012
Estimated Enrollment :
406 Patients enrolled
Trial Details
Trial ID
NCT01430507
Start Date
September 1 2011
End Date
December 1 2012
Last Update
December 28 2012
Active Locations (36)
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1
Advance Rheumatology Clinic
Hyderabad, Andhra Pradesh, India
2
Mahavir Hospital and Research Center
Hyderabad, Andhra Pradesh, India
3
Sri Deepti Rheumatology Center
Hyderabad, Andhra Pradesh, India
4
Krishna Institute of Medical Sciences
Secunderabad, Andhra Pradesh, India