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

Status

Completed

Phases

Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01870128

Enrollment

Registered

2013-06-05

Start date

2009-08-31

Completion date

2011-06-30

Last updated

2013-06-05

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Rheumatoid Arthritis

Keywords

Rheumatoid arthritis, Steroid

Brief summary

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.

Detailed 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.

Interventions

DRUGCombination 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

DRUGMethotrexate

Methotrexate 15 to 25 mg PO per week

DRUGCombination

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

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to 60 Years

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 -

Design outcomes

Primary

Measure	Time frame	Description
Response to treatment	22 months	To compare the response (EULAR criteria) to treatment in the three treatment groups.

Secondary

Measure	Time frame	Description
Disease activity score (DAS28)	22 months	To compare the disease activity score (DAS28) score and its defining variables (tender joint count, swollen joint count, erythrocyte sedimentation rate and patient global assessment on visual analogue scale).

Countries

India

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026