A RANDOMISED DOUBLE-BLIND PLACEBO CONTROLLED MULTICENTRE PHASE II STUDY OF ATACICEPT IN ANTI-TNFA NAIVE PATIENTS WITH MODERATE TO SEVERELY ACTIVE RHEUMATOID ARTHRITIS AND AN INADEQUATE RESPONSE TO METHOTREXATE - ATACICEPT IN ANTI TNF-a NAIVE SUBJECTS WITH RA

• Conditions: RHEUMATOID ARTHRITIS; MedDRA version: 9.1Level: LLTClassification code 10039073Term: Rheumatoid arthritis

• Registration Number: EUCTR2007-002536-29-IT
• Lead Sponsor: MERCK SERONO INTERNATIONAL SA

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2008-01-09
• Last Update Posted: 18 September 2012

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 264

Inclusion Criteria

1. Rheumatoid arthritis satisfying American College of Rheumatology (ACR) criteria for RA (22); see Appendix B) with a disease history of at least 6 months. 2. Male or female ≥18 years of age at time of Informed Consent. Active RA as defined by: ≥8 swollen joints (66 joint count), ≥8 tender joints (68 joint count), and CRP ≥10 mg/L. 4. Persistent and active RA despite MTX treatment (≥ 15 mg/week) lasting for >3 months. 5. Stable MTX dose (15-25 mg) for at least the last 28 days before SD 1. 6. Written informed consent, obtained before any study-related procedure. Subjects must review and understand the Informed Consent Form, and must fully understand the requirements of the study and be willing to comply with all study visits and assessments. 7. Women of childbearing potential must have a negative urine pregnancy test at the screening visit. For the purposes of this trial, women of childbearing potential are defined as all female subjects after puberty unless they are post-menopausal for at least two years or are surgically sterile. 8. Female patients of childbearing potential must be willing to avoid pregnancy by using an adequate method of contraception for four weeks prior to, during and three months after the last dose study medication. Women randomized to adalimumab will be required to maintain an adequate method of contraception for at least 5 months after the last dose. For the purposes of this study, women of childbearing potential is defined as: All female patients after puberty unless they are post-menopausal for at least two years, or are surgically sterile. Adequate contraception is defined as two barrier methods, or one barrier method with a spermicide, or an intrauterine device or use of the oral female contraceptive (or other hormonal methods).
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range

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: all DMARDs except MTX should be discontinued >28 days (>60 days for leflunomide) before SD 1 - More than one intra-articular steroid injection or parenteral glucocorticoid treatment within 28 days before SD 1 - Participation in any interventional clinical trial within 1 month before SD 1 (or within 5 half-lives of the investigated compound before SD 1, whichever is longer)- 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 - Known hypersensitivity to adalimumab or to any of the components of the formulated adalimumab and/or any other contraindications as per adalimumab label - Any surgical procedure, including bone or joint surgery or synovectomy, within 12 weeks before SD 1 or planned major surgery during the study period - Breastfeeding or pregnancy

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: 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 TNF ALFA THERAPY;Secondary Objective: - To evaluate the safety and tolerability profile of atacicept in treating anti-TNFα-naïve subjects with active RA and an inadequate response to methotrexate. - To gain further information on the effect of atacicept on biomarkers reflecting its mechanism of action (MoA) and disease activity. - To further characterise atacicept?s pharmacokinetic (PK) and Pharmacodynamic (PD)profiles.;Primary end point(s): The proportion of subjects achieving an ACR20 response at Week 26.