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

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

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

Conditions
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Rheumatoid Arthritis

Intervention / Treatment
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* Biological: Baminercept alfa 1
* Biological: Placebo
* Biological: Baminercept alfa 2
* Biological: Baminercept alfa 3
* Biological: Baminercept alfa 4
* Biological: Baminercept alfa 5


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: Placebo<br>subcutaneous administration of placebo given for 12 weeks | Biological: Placebo<br>* Placebo comparator<br>* Other names: LT beta;|
| Experimental: One Dose<br>BG9924 - dosage level administered as per Biogen Idec protocol | Biological: Baminercept alfa 1<br>* experimental - one dose level<br>* Other names: LT beta;|
| Experimental: Second Dose<br>BG9924 - dosage level administered as per Biogen Idec protocol | Biological: Baminercept alfa 2<br>* experimental - second dose level<br>* Other names: BG9924;|
| Experimental: Third Dose<br>BG9924 - dosage level administered as per Biogen Idec protocol | Biological: Baminercept alfa 3<br>* experimental - third dose level<br>* Other names: LT beta;|
| Experimental: Fourth Dose<br>BG9924 - dosage level administered as per Biogen Idec protocol | Biological: Baminercept alfa 4<br>* experimental - fourth dose level<br>* Other names: LT beta;|
| Experimental: Fifth Dose<br>BG9924 - dosage level administered as per Biogen Idec protocol | Biological: Baminercept alfa 5<br>* experimental - fifth dose level<br>* Other names: BG9924;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Evaluate efficacy of BG9924 in combination with methotrexate (MTX) in RA participants who have had an inadequate response to DMARD therapy |  | 3 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Assess the safety and tolerability of BG9924 in this participant population |  | 3 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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RA, Rheumatoid Arthritis, DMARD inadequate response, Methotrexate