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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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12 December 2020 |
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Main ID: |
NCT02644499 |
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Date of registration:
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30/12/2015 |
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Prospective Registration:
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Yes |
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Primary sponsor: |
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Public title:
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Comparison of Combination Disease Modifying Antirheumatic Drugs With Methotrexate Therapy in Early Rheumatoid Arthritis
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Scientific title:
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Comparison of Combination Disease Modifying Antirheumatic Drugs (DMARDs) With Single Drug (Methotrexate) Therapy in Early Rheumatoid Arthritis |
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Date of first enrolment:
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December 31, 2015 |
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Target sample size:
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186 |
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Recruitment status: |
Completed |
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URL:
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https://clinicaltrials.gov/show/NCT02644499 |
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Study type:
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Interventional |
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Study design:
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Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: None (Open Label).
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Phase:
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Phase 4
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Countries of recruitment
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India
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Contacts
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Name:
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Vir S Negi, DM |
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Address:
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Telephone:
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Email:
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Affiliation:
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Jawaharlal Institute of Postgraduate Medical Education & Research |
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Name:
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Jignesh B Usdadiya, MD |
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Address:
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Telephone:
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Email:
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Affiliation:
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Jawaharlal Institute of Postgraduate Medical Education & Research |
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Key inclusion & exclusion criteria
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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
Age minimum:
18 Years
Age maximum:
N/A
Gender:
All
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Health Condition(s) or Problem(s) studied
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Rheumatoid Arthritis
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Intervention(s)
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Drug: Folic Acid
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Drug: Prednisolone
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Drug: Hydroxychloroquine
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Drug: Methotrexate
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Drug: Leflunomide
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Primary Outcome(s)
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A good response according to European league against rheumatism (EULAR) response criteria and Functional ability with Indian health assessment questionnaire (iHAQ)
[Time Frame: 3 months]
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Secondary Outcome(s)
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Mean changes over time in erythrocyte sedimentation rate (ESR)
[Time Frame: 3 months]
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Adverse drug reactions
[Time Frame: 3 months]
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Disease activity as per ultrasound (US-7) score
[Time Frame: 3 months]
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Mean changes over time in early morning stiffness (EMS)
[Time Frame: 3 months]
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Radiographic progression assessed with Simple Erosion Narrowing Score (SENS)
[Time Frame: 3 months]
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Secondary ID(s)
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JIP/IEC/SC/2013/5/433
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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