Abatacept and Infliximab in Combination With Methotrexate in Subjects With Rheumatoid Arthritis

Bristol-Myers Squibb (BMS)

Status and phase: Completed; Phase 3

Conditions: Rheumatoid Arthritis

Treatments: Drug: Placebo (PLA) + MTX, DB; Drug: PLA + MTX switched to ABA+ MTX, DB; Drug: Infliximab (INF) + MTX, DB; Drug: Abatacept (ABA) + Methotrexate (MTX), double-blind (DB); Drug: ABA, open-label (OL)

Study type: Interventional

Funder types: Industry

Identifiers

NCT00095147

IM101-043

Details and patient eligibility

About

The purpose of this clinical research study is to learn if Abatacept or Infliximab in combination with Methotrexate demonstrate a greater reduction in disease activity over placebo.

Enrollment: 431 patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Diagnosis of Rheumatoid Arthritis
• At least 3 months prior treatment with Methotrexate (MTX)
• At least 10 swollen joints and 12 tender joints and C-Reactive Protein of at least 1 mg/dl
• Washout required for other disease modifying anti-rheumatic drugs (DMARDS)

Exclusion criteria

• participants who have failed more than 3 DMARDs
• participants previously treated with an approved biologic drug
• History of cancer in the last 5 years
• Severe or recurrent bacterial infection
• Any previous or current medical conditions that are contraindications to the use of TNF blocking agents
• Women of Child Bearing Potential

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

---

431 participants in 5 patient groups, including a placebo group

Abatacept (ABA) + Methotrexate (MTX) (double-blind [DB])

Active Comparator group

Description:

Days 1-365

Treatment:

Drug: Abatacept (ABA) + Methotrexate (MTX), double-blind (DB)

Infliximab + MTX (DB)

Active Comparator group

Description:

Days 1-365

Treatment:

Drug: Infliximab (INF) + MTX, DB

Placebo + MTX (DB)

Placebo Comparator group

Description:

Days 1-197

Treatment:

Drug: Placebo (PLA) + MTX, DB

Placebo + MTX switched to abatacept + MTX (DB)

Experimental group

Description:

Participants received placebo plus methotrexate for days 1-197, and abatacept plus methotrexate for days 198-365

Treatment:

Drug: PLA + MTX switched to ABA+ MTX, DB

Abatacept (open-label)

Experimental group

Description:

Days 365 to 729 All participants receive Active Drug

Treatment:

Drug: ABA, open-label (OL)