Assessment Of The Safety And Efficacy Of BG9924 In Rheumatoid Arthritis (RA) Patients - Full Text View

Sponsored by:	Biogen Idec
Information provided by:	Biogen Idec
ClinicalTrials.gov Identifier:	NCT00664716

Purpose

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.

Resource links provided by NLM:

MedlinePlus related topics: Rheumatoid Arthritis

Further study details as provided by Biogen Idec:

Primary Outcome Measures:

Evaluate efficacy of BG9924 in combination with MTX in RA patients who have had an inadequate response to DMARD therapy [ Time Frame: 3 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Assess the safety and tolerability of BG9924 in this patient population [ Time Frame: 3 months ] [ Designated as safety issue: No ]

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

Eligibility

Criteria

Key Inclusion Criteria:

Key Exclusion Criteria:

Serious local infection or systemic infection.
History (Hx) of recurrent infections requiring oral or parenteral anti-infective treatment.
Hx of tuberculosis (TB) or positive purified protein derivative (PPD) test during the screening period.
Clinical significant lab tests at screening.
Positive for Hep C or Hep B at screening.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00664716

Locations

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

Sponsors and Collaborators

Biogen Idec

Investigators

Study Director:

Biogen-Idec Investigator, MD

Biogen Idec

More Information

No publications provided

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

Keywords provided by Biogen Idec:

Rheumatoid Arthritis
RA
Methotrexate
DMARD inadequate response

Study placed in the following topic categories:

Autoimmune Diseases
Musculoskeletal Diseases
Joint Diseases
Arthritis

Connective Tissue Diseases
Arthritis, Rheumatoid
Methotrexate
Rheumatic Diseases

Additional relevant MeSH terms:

Autoimmune Diseases
Immune System Diseases
Musculoskeletal Diseases
Joint Diseases

Arthritis
Connective Tissue Diseases
Arthritis, Rheumatoid
Rheumatic Diseases

ClinicalTrials.gov processed this record on September 11, 2009