Substudy - Low Dose of Abatacept in Subjects With Rheumatoid Arthritis

Bristol-Myers Squibb (BMS)

Status and phase: Completed; Phase 3

Conditions: Rheumatoid Arthritis

Treatments: Drug: Abatacept

Study type: Interventional

Funder types: Industry

Identifiers

NCT00989235

IM101-023 LT (Sub study)

Eudrac # 2002-000784-26

Details and patient eligibility

About

The purpose of this exploratory sub-study was to evaluate from a clinical perspective the impact on disease activity of lowering the dose of abatacept from 10 mg/kg to 5 mg/kg in subjects who had achieved remission (Disease Activity Score 28 [DAS 28]-erythrocyte sedimentation rate [ESR] < 2.6) at Day 701 of study IM101023.

Enrollment: 108 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Subjects who have completed the main study, are willing to participate and have a DAS 28 ESR score of < 2.6 on Day 701 of the main study

Exclusion criteria

• None

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

---

108 participants in 2 patient groups

Abatacept (10 mg/Kg)

Active Comparator group

Treatment:

Drug: Abatacept

Drug: Abatacept

Abatacept (5 mg/Kg)

Active Comparator group

Treatment:

Drug: Abatacept

Drug: Abatacept