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

NCT02644499 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 186

Last updated 2019-10-01

No results posted yet for this study

Summary

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.

Conditions

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.

Sponsors & Collaborators

  • Jawaharlal Institute of Postgraduate Medical Education & Research

    lead OTHER_GOV

Principal Investigators

  • Vir S Negi, DM · Jawaharlal Institute of Postgraduate Medical Education & Research

  • Jignesh B Usdadiya, MD · Jawaharlal Institute of Postgraduate Medical Education & Research

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2015-12-31
Primary Completion
2017-02-17
Completion
2017-09-15

Countries

  • India

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02644499 on ClinicalTrials.gov