NCT01870128

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
60

participants targeted

Target at below P25 for phase_3 rheumatoid-arthritis

Timeline
Completed

Started Aug 2009

Shorter than P25 for phase_3 rheumatoid-arthritis

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 2009

Completed
1.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2011

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2011

Completed
2 years until next milestone

First Submitted

Initial submission to the registry

May 30, 2013

Completed
6 days until next milestone

First Posted

Study publicly available on registry

June 5, 2013

Completed
Last Updated

June 5, 2013

Status Verified

June 1, 2013

Enrollment Period

1.8 years

First QC Date

May 30, 2013

Last Update Submit

June 3, 2013

Conditions

Rheumatoid Arthritis

Keywords

Rheumatoid arthritisSteroid

Outcome Measures

Primary Outcomes (1)

  • Response to treatment

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

    22 months

Secondary Outcomes (1)

  • Disease activity score (DAS28)

    22 months

Study Arms (3)

Methotrexate

ACTIVE COMPARATOR

Single agent Methotrexate 15 to 25 mg PO per week

Drug: Methotrexate

Combination

ACTIVE COMPARATOR

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

Drug: Combination

Combination Steroid

EXPERIMENTAL

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

Drug: Combination Steroid

Interventions

Combination SteroidDRUG

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

Also known as: Methylprednisolone 1000 mg intravenous for 3 days
Combination Steroid
MethotrexateDRUG

Methotrexate 15 to 25 mg PO per week

Also known as: Methotrexate 15 to 25 mg PO per week
Methotrexate
CombinationDRUG

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

Also known as: Methotrexate 15 to 25 mg PO per week, Hydroxychloroquine 200 mg Twice daily, Sulfasalazine 2000 to 3000 mg per day
Combination

Eligibility Criteria

Age18 Years - 60 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • 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 -

You may not qualify if:

  • 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 -

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

AIIMS

New Delhi, National Capital Territory of Delhi, 110029, India

Location

MeSH Terms

Conditions

Arthritis, Rheumatoid

Interventions

MethylprednisoloneMethotrexateHydroxychloroquine

Condition Hierarchy (Ancestors)

ArthritisJoint DiseasesMusculoskeletal DiseasesRheumatic DiseasesConnective Tissue DiseasesSkin and Connective Tissue DiseasesAutoimmune DiseasesImmune System Diseases

Intervention Hierarchy (Ancestors)

PrednisolonePregnadienetriolsPregnadienesPregnanesSteroidsFused-Ring CompoundsPolycyclic CompoundsAminopterinPterinsPteridinesHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-RingHeterocyclic CompoundsChloroquineAminoquinolinesQuinolines

Study Officials

  • ATUL BATRA, MD

    All India Institute of Medical Sciences

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Senio Resident

Study Record Dates

First Submitted

May 30, 2013

First Posted

June 5, 2013

Study Start

August 1, 2009

Primary Completion

June 1, 2011

Study Completion

June 1, 2011

Last Updated

June 5, 2013

Record last verified: 2013-06

Locations

IN(1)