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

Primary Purpose

Rheumatoid Arthritis

Status
Completed
Phase
Phase 3
Locations
India
Study Type
Interventional
Intervention
Combination Steroid
Methotrexate
Combination
Sponsored by
All India Institute of Medical Sciences, New Delhi
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Rheumatoid Arthritis focused on measuring Rheumatoid arthritis, Steroid

Eligibility Criteria

18 Years - 60 Years (Adult)All SexesDoes not accept 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 -

Sites / Locations

  • AIIMS

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Active Comparator

Active Comparator

Experimental

Arm Label

Methotrexate

Combination

Combination Steroid

Arm Description

Single agent 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

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

Outcomes

Primary Outcome Measures

Response to treatment
To compare the response (EULAR criteria) to treatment in the three treatment groups.

Secondary Outcome Measures

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).

Full Information

First Posted
May 30, 2013
Last Updated
June 3, 2013
Sponsor
All India Institute of Medical Sciences, New Delhi
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1. Study Identification

Unique Protocol Identification Number
NCT01870128
Brief Title
Comparison of Three Different Treatment Regimes in Early Rheumatoid Arthritis: A Randomized Open-labelled Trial
Official Title
Comparison of Three Different Treatment Regimes in Early Rheumatoid Arthritis: A Randomized Open-labelled Trial
Study Type
Interventional

2. Study Status

Record Verification Date
June 2013
Overall Recruitment Status
Completed
Study Start Date
August 2009 (undefined)
Primary Completion Date
June 2011 (Actual)
Study Completion Date
June 2011 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
All India Institute of Medical Sciences, New Delhi

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Rheumatoid Arthritis
Keywords
Rheumatoid arthritis, Steroid

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
60 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Methotrexate
Arm Type
Active Comparator
Arm Description
Single agent Methotrexate 15 to 25 mg PO per week
Arm Title
Combination
Arm Type
Active Comparator
Arm Description
Methotrexate 15 to 25 mg PO per week Hydroxychloroquine 200 mg Twice daily Sulfasalazine 2000 to 3000 mg per day
Arm Title
Combination Steroid
Arm Type
Experimental
Arm 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
Intervention Type
Drug
Intervention Name(s)
Combination Steroid
Other Intervention Name(s)
Methylprednisolone 1000 mg intravenous for 3 days
Intervention Description
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
Intervention Name(s)
Methotrexate
Other Intervention Name(s)
Methotrexate 15 to 25 mg PO per week
Intervention Description
Methotrexate 15 to 25 mg PO per week
Intervention Type
Drug
Intervention Name(s)
Combination
Other Intervention Name(s)
Methotrexate 15 to 25 mg PO per week, Hydroxychloroquine 200 mg Twice daily, Sulfasalazine 2000 to 3000 mg per day
Intervention Description
Methotrexate 15 to 25 mg PO per week Hydroxychloroquine 200 mg Twice daily Sulfasalazine 2000 to 3000 mg per day
Primary Outcome Measure Information:
Title
Response to treatment
Description
To compare the response (EULAR criteria) to treatment in the three treatment groups.
Time Frame
22 months
Secondary Outcome Measure Information:
Title
Disease activity score (DAS28)
Description
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).
Time Frame
22 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Rheumatoid Arthritis diagnosed on the basis of revised American college of rheumatology criteria,1987 Age >18 years Early Rheumatoid Arthritis i.e. less than 2 years duration Patient giving consent to participate in study Disease Modifying Anti-Rheumatic Drugs naive - Exclusion Criteria: Pregnant and lactating patient or planning to conceive in next year Patient who had joint surgery in last 6 months Co morbidities such as liver disease, kidney disease, hematological malignancies Uncontrolled hypertension, diabetes mellitus Coronary artery disease -
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
ATUL BATRA, MD
Organizational Affiliation
All India Institute of Medical Sciences, New Delhi
Official's Role
Principal Investigator
Facility Information:
Facility Name
AIIMS
City
New Delhi
State/Province
Delhi
ZIP/Postal Code
110029
Country
India

12. IPD Sharing Statement

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

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