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

A Phase 2a, Randomised, Double-Blind, Placebo-Controlled, Multicentre Study to Evaluate the Efficacy, Safety and Tolerability of BG00012 When Given With Methotrexate to Subjects With Active RA Who Have Had an Inadequate Response to Conventional Disease-Modifying Anti-rheumatic Drug Therapy

Status

Completed

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00810836

Enrollment

153

Registered

2008-12-18

Start date

2008-12-31

Completion date

2010-03-31

Last updated

2013-09-16

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

Conditions

Rheumatoid Arthritis

Brief summary

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.

Detailed 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.

Interventions

DRUGBG00012

oral

DRUGplacebo

oral placebo

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

18 Years to 75 Years

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.

Design outcomes

Primary

Measure	Time frame
The primary objective is the proportion of subjects with ACR20 response in their RA at Week 12.	12 weeks

Secondary

Measure	Time frame
To determine the safety and tolerability of BG00012 with methotrexate in this population.	12 weeks

Countries

Australia, Canada, Czechia, India, Poland, Slovakia

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026