Study of Atacicept in Anti-TNFα-naïve Patients With Moderate to Severely Active Rheumatoid Arthritis and an Inadequate Response to Methotrexate
This study has been completed.
Sponsor:
EMD Serono
Information provided by (Responsible Party):
EMD Serono
ClinicalTrials.gov Identifier:
NCT00595413
First received: January 7, 2008
Last updated: August 23, 2011
Last verified: August 2011
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Purpose
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 RA, inadequate response to methotrexate (MTX) and no previous exposure to anti-TNFα therapy
| Condition | Intervention | Phase |
|---|---|---|
|
Rheumatoid Arthritis |
Drug: Atacicept Other: Placebo Biological: Humira |
Phase 2 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Investigator) Primary Purpose: Treatment |
| Official Title: | 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 |
Resource links provided by NLM:
Further study details as provided by EMD Serono:
Primary Outcome Measures:
- The proportion of subjects achieving an ACR20 response at Week 26. [ Time Frame: Approximately Monthly ] [ Designated as safety issue: No ]
| Enrollment: | 311 |
| Study Start Date: | September 2007 |
| Study Completion Date: | August 2009 |
| Primary Completion Date: | May 2009 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: 1
Atacicept
|
Drug: Atacicept
Atacicept 150 mg tiw for 4 weeks, qw weeks 5 thru 25
|
|
Experimental: 2
Atacicept alternating with placebo
|
Drug: Atacicept
Atacicept 150 mg qw weeks 1 thru 25
|
|
Placebo Comparator: 3
Placebo
|
Other: Placebo
Placebo qw weeks 1 thru 25
|
|
Active Comparator: 4
Humira
|
Biological: Humira
Humira 40 mg eow
|
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria:
- Male and female subjects ≥ 18 years of age at the time of Informed Consent who have rheumatoid arthritis satisfying American College of Rheumatology criteria and 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 ≥ 10mg/L and/or ESR ≥ 28 mm/hr, despite treatment with methotrexate (MTX) at a dose of ≥ 15 mg/week for > 3 months
Exclusion Criteria:
- 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-TNFα agents, rituximab, abatacept, tocilizumab, interleukin-1 receptor antagonist (IL-1Ra) and belimumab.
- Treatment with DMARDs other than MTX
- Participation in any interventional clinical trial within 1 month before SD1
- Methotrexate dose > 25 mg/week, prednisone dose >10 mg/day (or equivalent), or change in steroid or NSAID dosing regimen within 28 days before SD 1.
- Live vaccine or Ig treatment within 28 days before SD 1 or need for such treatment during the study (including follow-up).
- Any history or presence of active or latent tuberculosis, major infection requiring hospitalisation or intravenous anti-infectives within 28 days before SD 1.
- Other major concurrent illness or organ dysfunction.
- Serum IgG below 6 g/L.
- Known hypersensitivity to atacicept or to any of the components of the formulated atacicept.
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00595413
Locations
| United States, Massachusetts | |
| Rockland, Massachusetts, United States, 02370 | |
Sponsors and Collaborators
EMD Serono
Investigators
| Study Director: | Nils Kinnman | Merck Serono International SA, an affiliate of Merck KGaA Darmstadt, Germany |
More Information
Additional Information:
No publications provided by EMD Serono
Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
| Responsible Party: | EMD Serono |
| ClinicalTrials.gov Identifier: | NCT00595413 History of Changes |
| Other Study ID Numbers: | 27905, 2007-002536-29 |
| Study First Received: | January 7, 2008 |
| Last Updated: | August 23, 2011 |
| Health Authority: | United States: Food and Drug Administration |
Additional relevant MeSH terms:
|
Arthritis Arthritis, Rheumatoid Joint Diseases Musculoskeletal Diseases Rheumatic Diseases Connective Tissue Diseases Autoimmune Diseases Immune System Diseases Methotrexate Adalimumab Abortifacient Agents, Nonsteroidal Abortifacient Agents Reproductive Control Agents Physiological Effects of Drugs |
Pharmacologic Actions Therapeutic Uses Antimetabolites, Antineoplastic Antimetabolites Molecular Mechanisms of Pharmacological Action Antineoplastic Agents Dermatologic Agents Enzyme Inhibitors Folic Acid Antagonists Immunosuppressive Agents Immunologic Factors Antirheumatic Agents Nucleic Acid Synthesis Inhibitors Anti-Inflammatory Agents |
ClinicalTrials.gov processed this record on May 19, 2013