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

Rheumatoid Arthritis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01870128
• Other study ID #: T-54/ 12.06.2009
• Status: Completed
• Phase: Phase 3
• First received: May 30, 2013
• Last updated: June 3, 2013
• Start date: August 2009
• Est. completion date: June 2011

Study information

• Verified date: June 2013
• Source: All India Institute of Medical Sciences, New Delhi
• Contact: n/a
• Is FDA regulated: No
• Health authority: India: Indian Council of Medical Research
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 60
• Est. completion date: June 2011
• Est. primary completion date: June 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 60 Years

Eligibility

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 -

Study Design

Allocation: Randomized, Endpoint Classification: Bio-equivalence Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Arthritis
• Arthritis, Rheumatoid
• Rheumatoid Arthritis

Intervention

Drug:
• 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
• Methotrexate
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

Locations

Country	Name	City	State
India	AIIMS	New Delhi	Delhi

Sponsors (1)

Lead Sponsor	Collaborator
All India Institute of Medical Sciences, New Delhi

Country where clinical trial is conducted

India, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Response to treatment	To compare the response (EULAR criteria) to treatment in the three treatment groups.	22 months	No
Secondary	Disease activity score (DAS28)	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).	22 months	No