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Baminercept alfa 1

Phase 2

Rheumatoid Arthritis | Monoclonal antibody | Immunology |Biogen Inc.|Last Updated: Jan 21, 2016

Success Probability

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Trial Design

RandomizedDouble-BlindPLACEBO_CONTROLLEDDMC
Total Trials1
Total Enrollment391

FDA Designations

No designations recorded

Clinical trial landscape

Baminercept alfa 1 · 1 trial · 1 indication

Phase 2 1
NCT00664716Assessment Of The Safety And Efficacy Of BG9924 In Rheumatoid Arthritis (RA) ParticipantsRheumatoid Arthritis
COMPLETED391 Analytics
PHASE2COMPLETED
Assessment Of The Safety And Efficacy Of BG9924 In Rheumatoid Arthritis (RA) Participants
Rheumatoid ArthritisUnlock trial analytics

Study Endpoints

Primary Endpoints

Evaluate efficacy of BG9924 in combination with methotrexate (MTX) in RA participants who have had an inadequate response to DMARD therapy
3 months

Secondary Endpoints

Assess the safety and tolerability of BG9924 in this participant population
3 months
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Study Design & Arms

AllocationRANDOMIZED
MaskingDOUBLE
ModelSINGLE_GROUP
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
PlaceboPLACEBO_COMPARATORsubcutaneous administration of placebo given for 12 weeks
One DoseEXPERIMENTALBG9924 - dosage level administered as per Biogen Idec protocol
Second DoseEXPERIMENTALBG9924 - dosage level administered as per Biogen Idec protocol
Third DoseEXPERIMENTALBG9924 - dosage level administered as per Biogen Idec protocol
Fourth DoseEXPERIMENTALBG9924 - dosage level administered as per Biogen Idec protocol
Fifth DoseEXPERIMENTALBG9924 - dosage level administered as per Biogen Idec protocol

Interventions

NameTypeDescription
Baminercept alfa 1BIOLOGICALexperimental - one dose level
PlaceboBIOLOGICALPlacebo comparator
Baminercept alfa 2BIOLOGICALexperimental - second dose level
Baminercept alfa 3BIOLOGICALexperimental - third dose level
Baminercept alfa 4BIOLOGICALexperimental - fourth dose level
Baminercept alfa 5BIOLOGICALexperimental - fifth dose level
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Eligibility Criteria

Age Range18 Years to 75 Years
SexALL
Healthy VolunteersNo
Study Sites8

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 an...

Countries:ArgentinaBrazilHungaryMexicoPolandRomaniaRussiaUnited Kingdom
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Frequently asked questions about Baminercept alfa 1

What is Baminercept alfa 1 used for?

Baminercept alfa 1 is an investigational monoclonal antibody being developed for the treatment of rheumatoid arthritis. It is currently in Phase 2 clinical development and has not been approved by regulatory authorities. The drug is being studied in patients with rheumatoid arthritis to assess its safety and efficacy.

Who makes Baminercept alfa 1?

Baminercept alfa 1 is being developed by Biogen Inc., a biotechnology company traded on the NASDAQ under the ticker symbol BIIB. The company is conducting clinical trials to evaluate the drug's potential in treating rheumatoid arthritis.

What phase is Baminercept alfa 1 in?

Baminercept alfa 1 is in Phase 2 clinical development. It is an investigational drug and has not been approved by the FDA or other regulatory agencies. The drug is being studied in a completed Phase 2 trial for rheumatoid arthritis.

What clinical trials is Baminercept alfa 1 in?

Baminercept alfa 1 has one completed Phase 2 clinical trial registered as NCT00664716, titled 'Assessment Of The Safety And Efficacy Of BG9924 In Rheumatoid Arthritis (RA) Participants'. This randomized, double-blind, placebo-controlled trial enrolled 391 participants across multiple countries including Argentina, Brazil, Hungary, Mexico, Poland, Romania, Russia, and the United Kingdom.

Is Baminercept alfa 1 the same as BG9924?

Yes, Baminercept alfa 1 is also known as BG9924. The clinical trial NCT00664716, which evaluated the drug in rheumatoid arthritis, used the name BG9924 in its title. Both names refer to the same investigational monoclonal antibody being developed by Biogen Inc.