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A Phase 3 Study of Abatacept in Chinese Patients With Active Rheumatoid Arthritis and Inadequate Response to Methotrexate

NCT02722694 · Status: UNKNOWN · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 360

Last updated 2016-09-13

No results posted yet for this study

Summary

The primary objective of this study is to demonstrate superior efficacy of abatacept 125mg administrated SC weekly comparing to placebo after 24 weeks treatment in Chinese subjects who have active rheumatoid arthritis, are receiving methotrexate and experiencing an inadequate response to methotrexate. This will be estimated by the proportion of subjects meeting the American College of Rheumatology (ACR) criteria for 20% improvement (ACR20).

Conditions

  • Rheumatoid Arthritis (RA)

Interventions

DRUG

Subcutaneous(SC) Abatacept

Subjects received 125mg weekly SC abatacept injections for 24 weeks. All subjects who complete 24 weeks double-blind treatment are eligible to enter open label period. During this period, subjects in placebo group will be switched to receive abatacept 125mg administered SC weekly till week 52. Subjects in abatacept group will continue to receive abatacept 125mg weekly.

OTHER

Placebo

Subjects received weekly SC placebo injections for 24 weeks

DRUG

Methotrexate

All Subjects received backup Methotrexate treatment.

Sponsors & Collaborators

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2016-08-31
Primary Completion
2017-06-30
Completion
2017-12-31

Countries

  • China

Study Locations

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Entities

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 NCT02722694 on ClinicalTrials.gov