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

Merck KGaA (EMD Serono)

Status and phase: Completed; Phase 2

Conditions: Rheumatoid Arthritis

Treatments: Drug: Atacicept; Drug: Placebo matched to atacicept

Study type: Interventional

Funder types: Industry

Identifiers

NCT00430495

27298

Details and patient eligibility

About

This was a double-blind, placebo-controlled, parallel-arm, multicentre, prospective dose-finding trial of the safety and efficacy of atacicept in subjects with active rheumatoid arthritis who had failed a three month therapeutic trial with a tumor necrosis factor alpha (TNFa) antagonist due to lack of efficacy.

Enrollment: 256 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. Rheumatoid arthritis (RA) satisfying American College of Rheumatology (ACR) diagnostic criteria with a disease history of at least one year

2. Male or female greater than or equal to (>=)18-years of age at time of informed consent

3. Active RA as defined by:

   • >=8 swollen joints (66-joint count),
   • >=8 tender joints (68-joint count), and
   • C-reactive protein (CRP) >=10 milligram per liter (mg/L) (central laboratory) and/or erythrocyte sedimentation rate (ESR) >= to 28 millimeter per hour (mm/h)

4. Failure of at least one TNFa antagonist therapy (previously or at the time of screening) as specified in the protocol

5. Other protocol defined inclusion criteria could apply

Exclusion criteria

1. Any condition, including laboratory findings or findings in the medical history or pre-trial assessments, that in the opinion of the Investigator constitutes a risk or a contraindication for the subject's participation in the trial or that could interfere with the trial objectives, conduct or evaluation
2. Treatment with biologics aiming at B cell modulation such as rituximab or belimumab within 2 years before study Day 1
3. Any previous treatment with anakinra (Kineret), abatacept (Orencia) or tocilizumab within 3 months before study Day 1
4. Use of etanercept (Enbrel) within 28 days before study Day 1, or of infliximab (Remicade) or adalimumab (Humira) within 60 days before study Day 1
5. Participation in any interventional clinical trial with an unapproved investigational therapy within the 3 months before the start of this study (or within 5 half-lives of the investigated compound before study Day 1, whichever is longer)
6. Other protocol defined exclusion criteria could apply

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

---

256 participants in 4 patient groups, including a placebo group

Atacicept 25 mg

Experimental group

Treatment:

Drug: Atacicept

Drug: Atacicept

Drug: Atacicept

Atacicept 75 mg

Experimental group

Treatment:

Drug: Atacicept

Drug: Atacicept

Drug: Atacicept

Atacicept 150 mg

Experimental group

Treatment:

Drug: Atacicept

Drug: Atacicept

Drug: Atacicept

Placebo

Placebo Comparator group

Treatment:

Drug: Placebo matched to atacicept