Atacicept in Anti-Tumor Necrosis Factor Alpha-naïve Subjects With Rheumatoid Arthritis (AUGUST II)

PHASE2CompletedINTERVENTIONAL
Enrollment

311

Participants

Timeline

Start Date

September 30, 2007

Primary Completion Date

October 31, 2009

Study Completion Date

October 31, 2009

Conditions
Rheumatoid Arthritis
Interventions
DRUG

Placebo matched to atacicept

Placebo matched to atacicept will be administered subcutaneously twice a week for initial 4 weeks, followed by once a week for subsequent 21 weeks.

DRUG

Atacicept: with loading dose

Atacicept will be administered subcutaneously at a dose of 150 milligram (mg) twice a week for initial 4 weeks as loading dose, followed by 150 mg once a week for subsequent 21 weeks.

DRUG

Atacicept

Atacicept will be administered subcutaneously at a dose of 150 mg once a week for 25 weeks.

BIOLOGICAL

Adalimumab

Adalimumab (Humira®) will be administered subcutaneously at a dose of 40 mg every other week for 25 weeks.

Trial Locations (2)

Unknown

Please Contact US Medical Information, Rockland

Please contact the Merck KGaA Communication Center, Darmstadt

Sponsors

Lead Sponsor

All Listed Sponsors
collaborator

Merck KGaA, Darmstadt, Germany

INDUSTRY

lead

EMD Serono

INDUSTRY

NCT00595413 - Atacicept in Anti-Tumor Necrosis Factor Alpha-naïve Subjects With Rheumatoid Arthritis (AUGUST II) | Biotech Hunter | Biotech Hunter