A Phase 3, Multi-Center, Randomized, Double-Blind, Placebo-Controlled Study and Open-Label Study to Evaluate the Efficacy and Safety of Abatacept in Combination Therapy With Methotrexate Versus Methotrexate Alone in Subjects With Active Rheumatoid Arthritis and Inadequate Response to Methotrexate

PHASE III, MULTICENTER, RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED STUDY TO EVALUATE THE SAFETY AND CLINICAL EFFICACY OF THE COMBINED TREATMENT OF BMS-188667 PLUS METOTREXATE VERSUS METOTREXATE ONLY IN PATIENTS WITH ACTIVE RHEUMATOID ARTHRITIS WITH INADEQUATE METOTREXATE RESPONSE.

Status

Active, not recruiting

Phases

Early Phase 1

Study type

Interventional

Source

REPEC

Registry ID

PER-079-02

Enrollment

Registered

2002-12-12

Start date

Unknown

Completion date

Unknown

Last updated

2023-09-04

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Interventions

Abatacept + Methotrexate Type of group

Short term: Abatacept was dosed by weight with participants weighing 100 kg received abatacept 1 g. Participants continued treatment with methotrexate (MTX) orally or parenterally at a minimum dose of 15 mg. Group name:Abatacept + Methotrexate Open Label Type of group

Open label: Abatacept was administered intravenously by weight at 10 mg / kg in the OL period in staggered doses, so that participants weighing 100 kg received abatacept 1 g. The MTX was continued with the dose used in the DB period.

Eligibility

Inclusion criteria

Inclusion criteria: Rheumatoid Arthritis (RA) for greater than 1 year from the time of initial diagnosis of RA. Participants must have been taking methotrexate for at least 3 months with at least a weekly dose of 15 mg.

Exclusion criteria

Exclusion criteria: Women who are pregnant or nursing. Women who have obtained a positive result in the pregnancy test performed during the enrollment or before the administration of the study drug. Women of childbearing age who are unwilling or unable to use a method of birth control that is acceptable throughout the study and during a period of up to 10 weeks after the last infusion of the study medication.

Design outcomes

Primary

Measure	Time frame
Outcome name:ACR 20 response requires a patient to have a 20% reduction in the number of swollen and tender joints, and a reduction of 20% in three of the following five parameters: physician global assessment of disease, patient global assessment of disease, patient assessment of pain, C-reactive protein or erythrocyte sedimentation rate, and degree of disability in Health Assessment Questionnaire (HAQ) score. A participant achieved a sustained ACR 20 response if the participant had ACR 20 observed for at least 2 consecutive study visits. Measure:Number of American College of Rheumatology 20 (ACR 20) Responders at Day 169 Timepoints:day 169	—

Measure

Time frame

Outcome name:ACR 20 response requires a patient to have a 20% reduction in the number of swollen and tender joints, and a reduction of 20% in three of the following five parameters: physician global assessment of disease, patient global assessment of disease, patient assessment of pain, C-reactive protein or erythrocyte sedimentation rate, and degree of disability in Health Assessment Questionnaire (HAQ) score. A participant achieved a sustained ACR 20 response if the participant had ACR 20 observed for at least 2 consecutive study visits. Measure:Number of American College of Rheumatology 20 (ACR 20) Responders at Day 169 Timepoints:day 169

—

Secondary

Measure	Time frame
Outcome name:This analysis determined whether participants in the OL period were RF positive or RF negative based on serum samples. A positive value for RF was > 20 IU/ml; a negative value for RF was ≤ 20 IU/mL. Measure:BL Rheumatoid Factor (RF) Status for Participants Continuing in the OL Period Timepoints:day 365	—

Countries

Canada, Peru, United States

Outcome results