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

Biogen

Status and phase

Completed

Phase 2

Conditions

Rheumatoid Arthritis

Treatments

Biological: Placebo

Biological: Baminercept alfa 4

Biological: Baminercept alfa 2

Biological: Baminercept alfa 5

Biological: Baminercept alfa 3

Biological: Baminercept alfa 1

Study type

Interventional

Funder types

Industry

Identifiers

NCT00664716

104RA202

Details and patient eligibility

About

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

Enrollment

391 patients

Sex

All

Ages

18 to 75 years old

Volunteers

No Healthy Volunteers

Inclusion and exclusion 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/Exclusion criteria may apply.

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Single Group Assignment

Masking

Double Blind

391 participants in 6 patient groups, including a placebo group

Placebo

Placebo Comparator group

Description:

subcutaneous administration of placebo given for 12 weeks

Treatment:

Biological: Placebo

One Dose

Experimental group

Description: