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

Rheumatoid Arthritis Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00810836
• Other study ID #: 109RA201
• Status: Completed
• Phase: Phase 2
• First received: December 17, 2008
• Last updated: September 12, 2013
• Start date: December 2008
• Est. completion date: March 2010

Study information

• Verified date: March 2011
• Source: Biogen
• Contact: n/a
• Is FDA regulated: No
• Health authority: Australia: Department of Health and Ageing Therapeutic Goods AdministrationCzech Republic: State Institute for Drug ControlPoland: Ministry of HealthCzech Republic: Ethics CommitteeSlovakia: State Institute for Drug ControlAustralia: Human Research Ethics CommitteeCanada: Health CanadaIndia: Indian Council of Medical Research
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 153
• Est. completion date: March 2010
• Est. primary completion date: February 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 75 Years

Eligibility

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.

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Arthritis
• Arthritis, Rheumatoid
• Rheumatoid Arthritis

Intervention

Drug:
• BG00012
oral
• BG00012
Oral
• placebo
oral placebo

Locations

Country	Name	City	State
Australia	Research Site	Woodville	South Australia
Australia	Research Site	Woolloongabba	Queensland
Canada	Research Site	New Market
Canada	Research Site	Ottawa
Canada	Research Site	Rothesay
Canada	Research Site	Sarnia	Ontario
Czech Republic	Research Site	Active, not recruiting
Czech Republic	Research Site	Pardubice
Czech Republic	Research Site	Uh. Hradiste
Czech Republic	Research Site	Zlin
India	Research Site	Bangalore
India	Research Site	Hyderabaad
India	Research Site	Hyderabad
India	Research Site	Lucknow
Poland	Research Site	Bialystock
Poland	Research Site	Grodzisk Mazowiecki
Poland	Research Site	Lublin
Poland	Research Site	Poznan
Poland	Research Site	Torun
Poland	Research Site	Warsaw
Poland	Research Site	Warszawa
Slovakia	Research Site	Banska Bysterica
Slovakia	Research Site	Bratislava
Slovakia	Research Site	Kosice
Slovakia	Research Site	Piestany

Sponsors (1)

Lead Sponsor	Collaborator
Biogen

Countries where clinical trial is conducted

Australia,  Canada,  Czech Republic,  India,  Poland,  Slovakia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The primary objective is the proportion of subjects with ACR20 response in their RA at Week 12.		12 weeks	No
Secondary	To determine the safety and tolerability of BG00012 with methotrexate in this population.		12 weeks	Yes