Efficacy and Safety Study of BG00012 With Methotrexate in Patients With Active Rheumatoid Arthritis

Biogen

Status and phase: Completed; Phase 2

Conditions: Rheumatoid Arthritis

Treatments: Drug: placebo; Drug: BG00012

Study type: Interventional

Funder types: Industry

Identifiers

NCT00810836

109RA201

Details and patient eligibility

About

The purpose of this study is to investigate whether the drug BG00012 can improve the symptoms of rheumatoid arthritis (RA) in patients who are already taking methotrexate for RA, but who still suffer symptoms of RA. The purpose is also to ensure that the combination of methotrexate is safe for patients to take and that any side effects are acceptable to patients with RA.

Full description

The study is a double-blind, placebo-controlled study of BG00012 plus methotrexate, versus methotrexate alone, in patients with active RA, who have had an incomplete response to other conventional disease modifying anti-rheumatic (DMARD) therapy.

Enrollment: 153 patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• must be taking methotrexate
• inadequate response to at least one conventional DMARD
• swollen and tender joint count

Exclusion criteria

• previous treatment with TNF or any other biologic or prosorba column

Other criteria also apply.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

---

153 participants in 3 patient groups, including a placebo group

1

Active Comparator group

Description:

BG00012 480 mg/day

Treatment:

Drug: BG00012

Drug: BG00012

2

Active Comparator group

Description:

BG00012 720 mg/day

Treatment:

Drug: BG00012

Drug: BG00012

3

Placebo Comparator group

Treatment:

Drug: placebo