NCT00595413

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

A Randomised, Double-blind, Placebo Controlled, Multi-centre Phase II Study of Atacicept in Anti-TNFα-naïve Patients With Moderate to Severely Active Rheumatoid Arthritis and an Inadequate Response to Methotrexate

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 311 (actual)
• Sponsor: EMD Serono · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The primary objective of this study is to evaluate the efficacy of atacicept compared to placebo in the treatment of signs and symptoms in a subject population with active rheumatoid arthritis (RA), inadequate response to methotrexate (MTX) and no previous exposure to anti-tumor necrosis factor alpha (anti-TNFalpha) therapy.

Conditions

• Rheumatoid Arthritis

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2007-09-01
• Primary completion: 2009-10-01
• Completion: 2009-10-01
• First posted: 2008-01-16
• Last updated: 2016-02-17
• Results posted: 2016-02-17

Locations

2 sites across 2 countries: United States, Germany