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Efficacy and Safety Study of Abatacept Subcutaneous Plus Methotrexate in Inducing Remission in Adults With Very Early Rheumatoid Arthritis

NCT01142726 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 511

Last updated 2016-01-14

Study results available
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Summary

The primary purpose of the protocol is to demonstrate the ability of abatacept plus methotrexate to induce remission in patients with very early rheumatoid arthritis after 12 months of treatment and to maintain remission following 6 months of drug withdrawal.

Conditions

Interventions

DRUG

Abatacept

Injection, subcutaneous, 125 mg by syringe, once weekly, 12 months

DRUG

Methotrexate

Tablets, oral, 2.5 mg, once weekly, 12 months

DRUG

Abatacept placebo

Injection, subcutaneous, to match 125 mg by syringe, once weekly, 12 months

DRUG

Methotrexate placebo

Tablets, oral, to match 2.5-mg tablet, once weekly, 12 months

Sponsors & Collaborators

Principal Investigators

  • Bristol-Myers Squibb · Bristol-Myers Squibb

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2010-12-31
Primary Completion
2013-09-30
Completion
2014-10-31

Countries

  • United States
  • Australia
  • Belgium
  • Canada
  • Denmark
  • Finland
  • France
  • Germany
  • Italy
  • Mexico
  • Poland
  • Russia
  • South Africa
  • South Korea
  • Sweden

Study Locations

More Related Trials

Entities

Drugs
Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01142726 on ClinicalTrials.gov