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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2009-08-31

Study Completion Date

2011-06-30

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Rheumatoid Arthritis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Methotrexate

Single agent Methotrexate 15 to 25 mg PO per week

Group Type ACTIVE_COMPARATOR

Methotrexate

Intervention Type DRUG

Methotrexate 15 to 25 mg PO per week

Combination

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

Group Type ACTIVE_COMPARATOR

Combination

Intervention Type DRUG

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

Combination Steroid

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

Group Type EXPERIMENTAL

Combination Steroid

Intervention Type DRUG

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

Interventions

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Combination Steroid

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

Intervention Type DRUG

Methotrexate

Methotrexate 15 to 25 mg PO per week

Intervention Type DRUG

Combination

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

Intervention Type DRUG

Other Intervention Names

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

Eligibility Criteria

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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 -

Minimum Eligible Age

18 Years

Maximum Eligible Age

60 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No