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

NCT00595413 | Completed Phase 2 Results

• 2 other identifiers: 279052007-002536-29
• Study Type: interventional
• Target: 311
• Locations: 2 countries
• Sites: 2

Brief 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

Keywords

Rheumatoid arthritis; Atacicept; Adalimumab; Humira®

Outcome Measures

Primary Outcomes (1)

• Percentage of Participants Achieving American College of Rheumatology 20 Response Based on C-reactive Protein (ACR20-CRP) at Week 26

  ACR20-CRP response is defined as greater than or equal to (\>=) 20 percent (%) improvement from Baseline in both tender joint counts (based on a total of 68 joints) and swollen joint counts (based on a total of 66 joints) together with \>=20% improvement from Baseline in at least 3 of the following 5 measures: 1) participant's assessment of pain; 2) participant's global assessment of disease activity; 3) physician's global assessment of disease activity; 4) participant's assessment of physical function; and 5) acute-phase marker (CRP).

  Week 26

Secondary Outcomes (4)

• Percentage of Participants Achieving American College of Rheumatology 50 Response Based on CRP (ACR50-CRP) at Week 26

  Week 26

• Percentage of Participants Achieving American College of Rheumatology 70 Response Based on CRP (ACR70-CRP) at Week 26

  Week 26

• Percentage of Participants With Good or Moderate European League Against Rheumatism (EULAR) Responses at Week 26

  Week 26

• Number of Participants With Treatment-Emergent Adverse Events (TEAEs) and Serious TEAEs

  From the first dose of study drug up to 30 days after the last dose of study drug, assessed up to Week 38

Study Arms (4)

Atacicept 150 mg with loading dose

EXPERIMENTAL

Drug: Atacicept: with loading dose

Atacicept 150 mg without loading dose

EXPERIMENTAL

Drug: Atacicept

Adalimumab

ACTIVE COMPARATOR

Biological: Adalimumab

Placebo

PLACEBO COMPARATOR

Drug: Placebo matched to atacicept

Interventions

Placebo matched to atacicept DRUG

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

Placebo

Atacicept: with loading dose DRUG

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.

Atacicept 150 mg with loading dose

Atacicept DRUG

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

Atacicept 150 mg without loading dose

Adalimumab BIOLOGICAL

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

Also known as: Humira®

Adalimumab

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Male or female subjects greater than or equal to (\>=) 18 years of age at the time of informed consent who have RA satisfying American College of Rheumatology (ACR) criteria with a disease history of at least 6 months
• Subjects must have active disease, defined by \>=8 swollen joints (out of 66), \>=8 tender joints (out of 68) and CRP \>=10 milligram per liter (mg/L) and/or erythrocyte sedimentation rate (ESR) \>=28 millimeter per hour (mm/hr), despite treatment with MTX at a dose of \>=15 milligram per week (mg/week) for greater than (\>) 3 months

You may not qualify if:

• Inflammatory joint disease other than RA
• Previous or concurrent treatment with any approved or investigational biological compound for RA, including but not restricted to any anti-TNFalpha agents, rituximab, abatacept, tocilizumab, interleukin-1 receptor antagonist (IL-1Ra) and belimumab
• Treatment with disease-modifying anti-rheumatic drug (DMARDs) other than MTX
• Participation in any interventional clinical trial within 1 month before study Day 1
• MTX dose \>25 mg/week, prednisone dose \>10 mg/day (or equivalent), or change in steroid or non-steroidal anti-inflammatory drug (NSAID) dosing regimen within 28 days before study Day 1
• Immunization with live vaccine or immunoglobulin (Ig) treatment within 28 days before study Day 1 or need for such treatment during the study (including follow-up)
• Any history or presence of active or latent tuberculosis, major infection requiring hospitalization or intravenous anti-infectives within 28 days before study Day 1
• Other major concurrent illness or organ dysfunction as specified in the protocol
• Serum IgG below 6 gram per liter (g/L)
• Known hypersensitivity to atacicept or to any of the components of the formulated atacicept

Sponsors & Collaborators

• EMD Serono: lead
• Merck KGaA, Darmstadt, Germany: collaborator

Study Sites (2)

Please Contact US Medical Information

Rockland, Massachusetts, United States

Location

Please contact the Merck KGaA Communication Center

Darmstadt, Germany

Location

Related Publications (1)

• van Vollenhoven RF, Kinnman N, Vincent E, Wax S, Bathon J. Atacicept in patients with rheumatoid arthritis and an inadequate response to methotrexate: results of a phase II, randomized, placebo-controlled trial. Arthritis Rheum. 2011 Jul;63(7):1782-92. doi: 10.1002/art.30372.

  PMID: 21452294 DERIVED

Related Links

• The European League Against Rheumatism (EULAR)

MeSH Terms

Conditions

Arthritis, Rheumatoid

Interventions

TACI receptor-IgG Fc fragment fusion protein; Adalimumab

Condition Hierarchy (Ancestors)

Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Connective Tissue Diseases; Skin and Connective Tissue Diseases; Autoimmune Diseases; Immune System Diseases

Intervention Hierarchy (Ancestors)

Antibodies, Monoclonal, Humanized; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins

Results Point of Contact

• Title: Merck KGaA Communication Center
• Organization: Merck Healthcare, a business of Merck KGaA, Darmstadt, Germany

service@merckgroup.com

+49-6151-72-5200

Study Officials

• Medical Responsible

  Merck Serono International SA, an affiliate of Merck KGaA Darmstadt, Germany

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 7, 2008
• First Posted: January 16, 2008
• Study Start: September 1, 2007
• Primary Completion: October 1, 2009
• Study Completion: October 1, 2009
• Last Updated: February 17, 2016
• Results First Posted: February 17, 2016

Record last verified: 2016-01

Locations

DE (1); US (1)