Comparison of Three Different Treatment Regimes in Early Rheumatoid Arthritis: A Randomized Open-labelled Trial

All India Institute Of Medical Science (AIIMS)

Status and phase: Completed; Phase 3

Conditions: Rheumatoid Arthritis

Treatments: Drug: Combination; Drug: Methotrexate; Drug: Combination Steroid

Study type: Interventional

Funder types: Other

Identifiers

NCT01870128

T-54/ 12.06.2009

Details and patient eligibility

About

Many studies have been conducted to evaluate the role of pulse steroids in early rheumatoid arthritis (RA) but no consensus exists. The aim of this study is to study the efficacy of various treatment regimens in early RA. Methods: This is a randomized open-labeled trial. Patients were randomised into three groups. In group A, patients were treated with single drug (methotrexate 15 mg/wk). The patients in Group B were treated with a combination of DMARDS (Methotrexate, sulfasalazine and hydroxychloroquine). The patients in Group C received combination therapy as in group B and 3 pulses of methylprednisolone intravenously.

Full description

Many studies have been conducted to evaluate the role of pulse steroids in early rheumatoid arthritis (RA) but no consensus exists. The aim of this study is to study the efficacy of various treatment regimens in early RA. Patients were divided into three groups. In group A, patients were treated with single drug (methotrexate 15 mg/wk). The patients in Group B were treated with a combination of DMARDS (Methotrexate, sulfasalazine and hydroxychloroquine). The patients in Group C received combination therapy as in group B and 3 pulses of methylprednisolone intravenously.

Enrollment: 60 patients

Sex: All

Ages: 18 to 60 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. Rheumatoid Arthritis diagnosed on the basis of revised American college of rheumatology criteria,1987
2. Age >18 years
3. Early Rheumatoid Arthritis i.e. less than 2 years duration
4. Patient giving consent to participate in study
5. Disease Modifying Anti-Rheumatic Drugs naive -

Exclusion criteria

1. Pregnant and lactating patient or planning to conceive in next year
2. Patient who had joint surgery in last 6 months
3. Co morbidities such as liver disease, kidney disease, hematological malignancies
4. Uncontrolled hypertension, diabetes mellitus
5. Coronary artery disease -

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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60 participants in 3 patient groups

Methotrexate

Active Comparator group

Description:

Single agent Methotrexate 15 to 25 mg PO per week

Treatment:

Drug: Methotrexate

Combination

Active Comparator group

Description:

Methotrexate 15 to 25 mg PO per week Hydroxychloroquine 200 mg Twice daily Sulfasalazine 2000 to 3000 mg per day

Treatment:

Drug: Combination

Combination Steroid

Experimental group

Description:

Methotrexate 15 to 25 mg PO per week Hydroxychloroquine 200 mg Twice daily Sulfasalazine 2000 to 3000 mg per day Methylprednisolone 1000 mg intravenous per day for 3 days

Treatment:

Drug: Combination Steroid