Health Condition 1: null- Rheumatoid Arthritis
Conditions
Interventions
Low dose revamilast for 12 weeks
(Maximum 2 gm/day Paracetamol to be used as rescue medication)
Intervention2: Revamilast: Oral
Medium dose revamilast for 12 weeks
(Maximum 2 gm/day Paracetamol to be used as rescue medication)
Intervention3: Revamilast: Oral
High dose revamilast for 12 weeks
(Maximum 2 gm/day Paracetamol to be used as rescue medication)
Control Intervention1: Placebo: matching placebo in a triple dummy format. Oral
Once a day for 12 weeks
(Maximum 2 gm/day Paracetamol to be used as rescue medication)
Sponsors
Glenmark Pharmaceuticals Ltd
Eligibility
Inclusion criteria
Inclusion criteria: 1. Male or female 18 to 65 years of age 2. Documented history of RA; diagnosed according to the revised American College of Rheumatology criteria (ACR) 3. Active RA defined as patients with: a. More than 6 swollen joint counts b. More than 6 tender/painful joint counts, and c. At least two of the three following criteria: i. Rheumatoid Factor positive or Anti CCP positive ii. CRP more than 1.2 times upper limit of normal reference range or ESR >28 mm/hr iii. Morning stiffness lasting >45 min for at least last4 weeks 4. DAS-28 CRP values more than 4.5 at screening 5. 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 6. The patient¡¯s written informed consent to participate in the study 7. Female participants must have a negative serum pregnancy test at screening visit. 8. Males must agree to use barrier while on study medication and for 90 days after taking the last dose of study medication 9. Must meet the following laboratory criteria: a. Hemoglobin >9 g/dL b. White blood cell (WBC) count; >3.0 X 109/L c. Platelet count >100,000 /L (100 X 109/L) d. Serum creatinine e. Total bilirubin f. AST & ALT <1.5 times upper limit of normal
Exclusion criteria
Exclusion criteria: 1. Diagnosis of RA prior to 16 years of age 2. Non-degenerative joint diseases or other joint diseases that could interfere with the evaluation of RA 3. Patients with any other autoimmune rheumatic disorders with the exception of Sjogren?s syndrome. 4. Patients with first degree relative with immune deficiency 5. History of infection with human immunodeficiency virus and/or active hepatitis B or C 6. Severe disabling arthritis leaving the patient eligible for surgical intervention, or incapacitated and prostrated patients 7. Patients with a history of drug or alcohol abuse or chronic smoking 8. Uncontrolled diabetes mellitus 9. Concurrent diseases that might interfere with the conduct of the study, 10. ECG abnormalities judged by the investigator to be clinically significant 11. History of using any other test drug, one month before the beginning of this trial 12. Women who are pregnant or breast-feeding or on hormonal therapy 13. Patients who in the Investigator?s opinion might not be suitable for the study 14. Patients with a life expectancy of less than 1 year
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Percentage of patients achieving ACR20 responseTimepoint: 12 weeks | — |
Secondary
| Measure | Time frame |
|---|---|
| Change in DAS-28 scoreTimepoint: 12 weeks;Change in serum CRP and ESR valuesTimepoint: 12 weeks;Frequency and use of rescue medicationTimepoint: 12 weeks;Percentage of patients with ACR50 and ACR70 responseTimepoint: 12 weeks | — |
Countries
India, Philippines, Poland, Sri Lanka, United Kingdom
Contacts
Public ContactDr Shailendra Sachan
Glenmark Pharmaceuticals Ltd
Outcome results
None listed