Clinical trial NCT00810836: Efficacy and Safety Study of BG00012 With Methotrexate in Patients With Active Rheumatoid Arthritis
Official title: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Rheumatoid Arthritis
Lead sponsor: Biogen
Sponsor class: INDUSTRY
First posted: 2008-12-18
Enrollment: 153
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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.

Primary outcomes:
measure: The primary objective is the proportion of subjects with ACR20 response in their RA at Week 12.
timeFrame: 12 weeks
Secondary outcomes:
measure: To determine the safety and tolerability of BG00012 with methotrexate in this population.
timeFrame: 12 weeks
Other outcomes:
Locations:
city: Woolloongabba
country: Australia
facility: Research Site
state: Queensland
city: Woodville
country: Australia
facility: Research Site
state: South Australia
city: Sarnia
country: Canada
facility: Research Site
state: Ontario
city: New Market
country: Canada
facility: Research Site
city: Ottawa
country: Canada
facility: Research Site
city: Rothesay
country: Canada
facility: Research Site
city: Active, not recruiting
country: Czech Republic
facility: Research Site
city: Pardubice
country: Czech Republic
facility: Research Site
city: Uh. Hradiste
country: Czech Republic
facility: Research Site
city: Zlin
country: Czech Republic
facility: Research Site
city: Bangalore
country: India
facility: Research Site
city: Hyderabaad
country: India
facility: Research Site
city: Hyderabad
country: India
facility: Research Site
city: Lucknow
country: India
facility: Research Site
city: Bialystock
country: Poland
facility: Research Site
city: Grodzisk Mazowiecki
country: Poland
facility: Research Site
city: Lublin
country: Poland
facility: Research Site
city: Poznan
country: Poland
facility: Research Site
city: Torun
country: Poland
facility: Research Site
city: Warsaw
country: Poland
facility: Research Site
city: Warszawa
country: Poland
facility: Research Site
city: Banska Bysterica
country: Slovakia
facility: Research Site
city: Bratislava
country: Slovakia
facility: Research Site
city: Kosice
country: Slovakia
facility: Research Site
city: Piestany
country: Slovakia
facility: Research Site
Study officials:
References: