Assessment of the Safety and Efficacy of BG9924 in Rheumatoid Arthritis (RA) Patients - Full Text View

Assessment of the Safety and Efficacy of BG9924 in Rheumatoid Arthritis (RA) Patients (RESPOND-EXT)

This study has been terminated.

( Analysis of data from 104RA202 failed to meet primary endpoint )

First Received: April 21, 2008 Last Updated: January 9, 2009 History of Changes

Sponsored by:	Biogen Idec
Information provided by:	Biogen Idec
ClinicalTrials.gov Identifier:	NCT00664573

Purpose

To observe the long-term treatment with BG9924 when administered to patients with RA who previously participated in a Biogen Idec Study.

Condition	Intervention	Phase
Rheumatoid Arthritis	Biological: Baminercept alfa (BG9924)	Phase II

MedlinePlus related topics: Rheumatoid Arthritis

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double Blind (Subject, Investigator), Dose Comparison, Parallel Assignment, Safety/Efficacy Study
Official Title:	Assessment of Safety and Efficacy of BG9924 in Subjects With RA Who Have Participated in Study 104RA202.

Further study details as provided by Biogen Idec:

Primary Outcome Measures:

To Observe The Long-Term treatment with BG9924 When Administered to Subjects with RA who Previously Participated in a Biogen Idec Study [ Time Frame: Duration of this study is 18 months ] [ Designated as safety issue: Yes ]

Estimated Enrollment:	380
Study Start Date:	November 2007
Study Completion Date:	October 2008
Primary Completion Date:	October 2008 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
2: Experimental Drug: BG9924 - dose administered as per Biogen-Idec protocol	Biological: Baminercept alfa (BG9924) dosage administered as per Biogen-Idec protocol
1: Experimental Drug: BG9924 - dose administered as per Biogen-Idec protocol	Biological: Baminercept alfa (BG9924) dosage administered as per Biogen-Idec protocol
3: Experimental Drug: BG9924 - dose administered as per Biogen-Idec protocol	Biological: Baminercept alfa (BG9924) dosage administered as per Biogen-Idec protocol
4: Experimental Drug: BG9924 - dose administered as per Biogen-Idec protocol	Biological: Baminercept alfa (BG9924) dosage administered as per Biogen-Idec protocol

Eligibility

Criteria

Inclusion Criteria:

Exclusion Criteria:

Subjects with a significant change in their medical history from their previous BG9924 study
Any clinically significant infectious illness or serious local infection

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00664573

Locations

Argentina
Coordinating Research Site
Tucuman, Argentina, T4000AXL
Brazil
Coordinating Research Site
Sao Paulo, Brazil
Hungary
Coordinating Research Site
Budapest, Hungary, H-1036
Mexico
Coordinating Research Site
Cuernavaca, Mexico, 62270
Poland
Coordinating Research Site
Torun, Poland, 87-100
Romania
Coordinating Research Site
Braila, Romania, 810112
Russian Federation
Coordinating Research Site
Moscow, Russian Federation, 127644
United Kingdom, Yorkshire
Coordinating Research Site
Leeds, Yorkshire, United Kingdom, LS74SA

Sponsors and Collaborators

Biogen Idec

Investigators

Study Director:

Biogen-Idec Medic, MD

Biogen Idec

More Information

No publications provided

Responsible Party:	Biogen Idec ( Biogen Idec (Biogen Idec MD) )
Study ID Numbers:	104RA204
Study First Received:	April 21, 2008
Last Updated:	January 9, 2009
ClinicalTrials.gov Identifier:	NCT00664573 History of Changes
Health Authority:	United Kingdom: Medicines and Healthcare Products Regulatory Agency; Brazil: Ministry of Health; Mexico: Ministry of Health; Argentina: Administracion Nacional de Medicamentos, Alimentos y Tecnologia Medica; Hungary: National Institute of Pharmacy; Romania: National Medicines Agency; Poland: Ministry of Health; Russia: Ministry of Health and Social Development of the Russian Federation

Keywords provided by Biogen Idec:

Rheumatoid Arthritis
BG9924
Baminercept alfa

Safety
Methotrexate
Efficacy

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 May 07, 2009