Assessment Of The Safety And Efficacy Of BG9924 In Rheumatoid Arthritis (RA) Participants

Rheumatoid Arthritis Clinical Trial

— RESPOND  

Official title:

Assessment Of Safety, Efficacy, PK&PD Of BG9924 in RA Patients Who Have Had An Inadequate Response To Conventional DMARD Therapy.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00664716
• Other study ID #: 104RA202
• Status: Completed
• Phase: Phase 2
• First received: April 21, 2008
• Last updated: December 17, 2015
• Start date: July 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 AgencyBrazil: National Committee of Ethics in ResearchPoland: 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

Safety and efficacy of BG9924 in RA participants that have had an inadequate response to disease-modifying anti-rheumatic drug (DMARD) therapy.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 391
• 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

Key Inclusion Criteria:

• Diagnosis of RA (functional class I - III)

• Stable dose of MTX

• Inadequate response to at least one conventional DMARD therapy

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

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

Study Design

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

Related Conditions & MeSH terms

• Arthritis
• Arthritis, Rheumatoid
• Rheumatoid Arthritis

Intervention

Biological:
• Baminercept alfa 1
experimental - one dose level
• Placebo
Placebo comparator
• Baminercept alfa 2
experimental - second dose level
• Baminercept alfa 3
experimental - third dose level
• Baminercept alfa 4
experimental - fourth dose level
• Baminercept alfa 5
experimental - fifth dose level

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	Evaluate efficacy of BG9924 in combination with methotrexate (MTX) in RA participants who have had an inadequate response to DMARD therapy		3 months	No
Secondary	Assess the safety and tolerability of BG9924 in this participant population		3 months	No