Home
Search
Study Topics
Glossary
|
|
|
|
|
Sponsored by: |
Biogen Idec |
---|---|
Information provided by: | Biogen Idec |
ClinicalTrials.gov Identifier: | NCT00664716 |
Safety and efficacy of BG9924 in RA patients that have had an inadequate response to DMARD therapy
Condition | Intervention | Phase |
---|---|---|
Rheumatoid Arthritis |
Biological: Placebo Biological: baminercept alfa Biological: Baminercept alfa |
Phase II |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Double Blind (Subject, Investigator), Placebo Control, Single Group Assignment, Safety/Efficacy Study |
Official Title: | Assessment Of Safety, Efficacy, PK&PD Of BG9924 in RA Patients Who Have Had An Inadequate Response To Conventional DMARD Therapy. |
Estimated Enrollment: | 380 |
Study Start Date: | July 2007 |
Study Completion Date: | October 2008 |
Primary Completion Date: | October 2008 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
---|---|
1: Placebo Comparator
subcutaneous administration of placebo given for 12 weeks
|
Biological: Placebo
Placebo comparator
|
2: Experimental
BG9924 - dosage level administered as per Biogen Idec protocol
|
Biological: baminercept alfa
experimental - one dose level
|
3: Experimental
BG9924 - dosage level administered as per Biogen Idec protocol
|
Biological: Baminercept alfa
Experimental - second dose level
|
4: Experimental
BG9924 - dosage level administered as per Biogen Idec protocol
|
Biological: Baminercept alfa
Experimental - third dose level
|
5: Experimental
BG9924 - dosage level administered as per Biogen Idec protocol
|
Biological: Baminercept alfa
Experimental - fourth dose level
|
6: Experimental
BG9924 - dosage level administered as per Biogen Idec protocol
|
Biological: Baminercept alfa
Experimental - fifth dose level
|
Ages Eligible for Study: | 18 Years to 75 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Key Inclusion Criteria:
Key Exclusion Criteria:
Argentina | |
Coordinating Research Site | |
Tucuman, Argentina, T4000AXL | |
Brazil | |
Coordinating Research Site | |
Sao Paulo, Brazil, 04027-000 | |
Hungary | |
Coordinating Research Site | |
Budapest, Hungary, H2143 | |
Mexico | |
Coordinating Research Site | |
Cuernavaca, Mexico, 62270 | |
Poland | |
Coordinating Research Site | |
Torun, Poland, 87100 | |
Romania | |
Coordinating Research Site | |
Braila, Romania, 810112 | |
Russian Federation | |
Coordinating Research Site | |
Moscow, Russian Federation, 115522 | |
United Kingdom, Yorkshire | |
Coordinating Research Site | |
Leeds, Yorkshire, United Kingdom, LS7 4SA |
Study Director: | Biogen-Idec Investigator, MD | Biogen Idec |
Responsible Party: | Biogen Idec ( Biogen Idec (Biogen Idec MD) ) |
Study ID Numbers: | 104RA202 |
Study First Received: | April 21, 2008 |
Last Updated: | January 9, 2009 |
ClinicalTrials.gov Identifier: | NCT00664716 History of Changes |
Health Authority: | Argentina: Administracion Nacional de Medicamentos, Alimentos y Tecnologia Medica; Brazil: National Committee of Ethics in Research; Hungary: National Institute of Pharmacy; Mexico: Ministry of Health; Poland: Ministry of Health; Romania: National Medicines Agency; Russia: Ministry of Health and Social Development of the Russian Federation; United Kingdom: Medicines and Healthcare Products Regulatory Agency |
Rheumatoid Arthritis RA Methotrexate DMARD inadequate response |
Autoimmune Diseases Musculoskeletal Diseases Joint Diseases Arthritis |
Connective Tissue Diseases Arthritis, Rheumatoid Methotrexate Rheumatic Diseases |
Autoimmune Diseases Immune System Diseases Musculoskeletal Diseases Joint Diseases |
Arthritis Connective Tissue Diseases Arthritis, Rheumatoid Rheumatic Diseases |