Comparison of Combination Disease Modifying Antirheumatic Drugs With Methotrexate Therapy in Early Rheumatoid Arthritis

PHASE4CompletedINTERVENTIONAL
Enrollment

186

Participants

Timeline

Start Date

December 31, 2015

Primary Completion Date

February 17, 2017

Study Completion Date

September 15, 2017

Conditions
Rheumatoid Arthritis
Interventions
DRUG

Methotrexate

Methotrexate, a structural analogue of folic acid, can be administered orally or parenterally to treat a variety of rheumatic dise

DRUG

Leflunomide

Leflunomide inhibits pyrimidine synthesis, resulting in blockade of T-cell proliferation. Leflunomide is used in patients with moderate to severe active rheumatoid arthritis with early or late disease

DRUG

Hydroxychloroquine

Hydroxychloroquine (HCQ) is a well-tolerated DMARD that is commonly used in combination therapy regimens for RA. HCQ is more commonly used than chloroquine.

DRUG

Prednisolone

Low dose prednisolone (weeks 1-2: 15 mg/day, weeks 2-4: 10 mg/day, weeks 4-6: 5 mg/day and weeks 6-8: 2.5 mg/day then stop)

DRUG

Folic Acid

Folic acid is to be given to all patients receiving methotrexate at a dose of 5 mg twice a week.

Trial Locations (1)

605006

Jawaharlal Institute of Postgraduate Medical Education & Research (JIPMER), Puducherry

All Listed Sponsors
lead

Jawaharlal Institute of Postgraduate Medical Education & Research

OTHER_GOV

NCT02644499 - Comparison of Combination Disease Modifying Antirheumatic Drugs With Methotrexate Therapy in Early Rheumatoid Arthritis | Biotech Hunter | Biotech Hunter