A Phase 2 Dose-finding Study of Atacicept in Subjects With Rheumatoid Arthritis (AUGUST I)

PHASE2CompletedINTERVENTIONAL
Enrollment

256

Participants

Timeline

Start Date

December 31, 2006

Primary Completion Date

September 30, 2009

Study Completion Date

September 30, 2009

Conditions
Rheumatoid Arthritis
Interventions
DRUG

Atacicept

Atacicept was administered subcutaneously at a dose of 25 milligram (mg) twice a week for initial 4 weeks as loading dose, followed by 25 mg once a week for subsequent 21 weeks.

DRUG

Atacicept

Atacicept was administered subcutaneously at a dose of 75 mg twice a week for initial 4 weeks as loading dose, followed by 75 mg once a week for subsequent 21 weeks.

DRUG

Atacicept

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

DRUG

Placebo matched to atacicept

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

Trial Locations (2)

02370

EMD Serono, Rockland

Unknown

Merck/Serono, Canada

Sponsors

Lead Sponsor

All Listed Sponsors
collaborator

Merck KGaA, Darmstadt, Germany

INDUSTRY

lead

EMD Serono

INDUSTRY

NCT00430495 - A Phase 2 Dose-finding Study of Atacicept in Subjects With Rheumatoid Arthritis (AUGUST I) | Biotech Hunter | Biotech Hunter