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

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

Status

Completed

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00664716

Acronym

RESPOND

Enrollment

391

Registered

2008-04-23

Start date

2007-07-31

Completion date

2008-10-31

Last updated

2016-01-21

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Rheumatoid Arthritis

Keywords

Rheumatoid Arthritis, RA, DMARD inadequate response, Methotrexate

Brief summary

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

Interventions

BIOLOGICALBaminercept alfa 1

experimental - one dose level

BIOLOGICALPlacebo

Placebo comparator

BIOLOGICALBaminercept alfa 2

experimental - second dose level

BIOLOGICALBaminercept alfa 3

experimental - third dose level

BIOLOGICALBaminercept alfa 4

experimental - fourth dose level

BIOLOGICALBaminercept alfa 5

experimental - fifth dose level

Study design

Allocation

RANDOMIZED

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

DOUBLE (Subject, Investigator)

Eligibility

Sex/Gender

ALL

Age

18 Years to 75 Years

Healthy volunteers

Inclusion criteria

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/

Design outcomes

Primary

Measure	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

Measure	Time frame
Assess the safety and tolerability of BG9924 in this participant population	3 months

Countries

Argentina, Brazil, Hungary, Mexico, Poland, Romania, Russia, United Kingdom

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 7, 2026