104RA204 Assessment of the Safety and Efficacy of BG9924 in Rheumatoid Arthritis (RA) Participants

Rheumatoid Arthritis Clinical Trial

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Official title:

Assessment of Safety and Efficacy of BG9924 in Subjects With RA Who Have Participated in Study 104RA202.

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00664573
• Other study ID #: 104RA204
• Secondary ID: 2007-000733-19
• Status: Terminated
• Phase: Phase 2
• First received: April 21, 2008
• Last updated: December 17, 2015
• Start date: November 2007
• Est. completion date: October 2008

Study information

• Verified date: December 2015
• Source: Biogen
• Contact: n/a
• Is FDA regulated: No
• Health authority: Romania: National Medicines AgencyPoland: Ministry of HealthBrazil: Ministry of HealthMexico: Ministry of HealthHungary: National Institute of PharmacyUnited Kingdom: Medicines and Healthcare Products Regulatory AgencyArgentina: Administracion Nacional de Medicamentos, Alimentos y Tecnologia MedicaRussia: Ministry of Health of the Russian Federation
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 339
• Est. completion date: October 2008
• Est. primary completion date: October 2008
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 75 Years

Eligibility

Inclusion Criteria:

• Must be a participant from Study 104RA202 (NCT 00664716)

• Stable dose of Methotrexate for the duration of the study

Exclusion Criteria:

• Participants with a significant change in their medical history from their previous BG9924 study

• Any clinically significant infectious illness or serious local infection

NOTE: Other protocol defined Inclusion/Exclusion criteria may apply.

Study Design

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

Related Conditions & MeSH terms

• Arthritis
• Arthritis, Rheumatoid
• Rheumatoid Arthritis

Intervention

Biological:
• Baminercept alfa (BG9924)
dosage administered as per Biogen-Idec protocol

Locations

Country	Name	City	State
Argentina	Coordinating Research Site	Tucuman
Brazil	Coordinating Research Site	Sao Paulo
Hungary	Coordinating Research Site	Budapest
Mexico	Coordinating Research Site	Cuernavaca
Poland	Coordinating Research Site	Torun
Romania	Coordinating Research Site	Braila
Russian Federation	Coordinating Research Site	Moscow
United Kingdom	Coordinating Research Site	Leeds	Yorkshire

Sponsors (1)

Lead Sponsor	Collaborator
Biogen

Countries where clinical trial is conducted

Argentina,  Brazil,  Hungary,  Mexico,  Poland,  Romania,  Russian Federation,  United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	To Observe The Long-Term treatment with BG9924 When Administered to Participants with RA who Previously Participated in a Biogen Idec Study		Duration of this study is 18 months	Yes