Rheumatoid Arthritis Clinical Trial
Official title:
Comparison of Combination Disease Modifying Antirheumatic Drugs (DMARDs) With Single Drug (Methotrexate) Therapy in Early Rheumatoid Arthritis
Verified date | September 2019 |
Source | Jawaharlal Institute of Postgraduate Medical Education & Research |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
This study will be conducted to find out how well a patient of rheumatoid arthritis (RA) will respond to disease-modifying antirheumatic drugs (DMARDs). RA is a chronic inflammatory arthritis, which leads to joint damage & disability if not treated properly. A DMARD is used to treat RA that slows down or prevents joint damage, as opposed to just relieve pain or inflammation by painkillers. The study will be conducted at the Department of Clinical Immunology, JIPMER (Jawaharlal Institute of Postgraduate Medical Education & Research). Patients will receive either a single DMARD (Methotrexate) or combination DMARDs therapy (Methotrexate + Leflunomide + Hydroxychloroquine). During treatment course, routine blood investigations will be carried out to monitor treatment response and side effects.
Status | Completed |
Enrollment | 186 |
Est. completion date | September 15, 2017 |
Est. primary completion date | February 17, 2017 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility |
Inclusion Criteria: 1. Age > 18 years satisfying 2010 ACR (American college of rheumatology) - EULAR criteria for RA 2. Arthritis in one or more joint (s) 3. Symptom duration <1 year 4. DMARD naive 5. Patients with moderate to severe disease activity (DAS28 =3.2) Exclusion Criteria: 1. Disease in Remission/inactive disease (DAS28 criteria) 2. End stage disease (deformed fixed joints) 3. Patients with vasculitis or other severe extra-articular features 4. Contraindications to DMARD therapy (Chronic Alcoholism, Chronic liver disease, Evidence of acute/chronic infection, Chronic kidney disease, Patients with leucopenia (<3.0×109/l), thrombocytopenia (<150×109/l), aspartate aminotransferase (AST)/alanine aminotransferase (ALT)>2× upper normal value and creatinine level >150 µmol/l ) 5. Pregnant, lactating females or inadequate contraception 6. Patients unable to come for regular follow up |
Country | Name | City | State |
---|---|---|---|
India | Jawaharlal Institute of Postgraduate Medical Education & Research (JIPMER) | Pondicherry | Pondicherry UT |
Lead Sponsor | Collaborator |
---|---|
Jawaharlal Institute of Postgraduate Medical Education & Research |
India,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | A good response according to European league against rheumatism (EULAR) response criteria and Functional ability with Indian health assessment questionnaire (iHAQ) | A good response is defined as a decrease after randomization of disease activity score- 28 joints (DAS28) score by >1.2, and a resulting DAS28 score = 3.2. Indian version of HAQ (iHAQ) has been validated in patients with RA, which comprises 12 questions (nine basic and three advanced activity of daily living) relevant to the Indian population. For each question there is a four-level difficulty scale ranging from 0 to 3 that represent no difficulty ('0'), some difficulty ('1'), much difficulty ('2'), and inability to do ('3'). The final score is the mean of the highest scores across the eight categories and ranges from 0 to 3, with higher levels indicating more disability. |
3 months | |
Secondary | Mean changes over time in early morning stiffness (EMS) | 3 months | ||
Secondary | Mean changes over time in erythrocyte sedimentation rate (ESR) | 3 months | ||
Secondary | Disease activity as per ultrasound (US-7) score | 3 months | ||
Secondary | Radiographic progression assessed with Simple Erosion Narrowing Score (SENS) | 3 months | ||
Secondary | Adverse drug reactions | 3 months |
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