A Phase III multicentre, double blind, placebo-controlled, parallel group 52-week study to assess the efficacy and safety of 2 dose regimens of lyophilised CDP870 given subcutaneously as additional medication to methotrexate in the treatment of signs and symptoms and preventing structural damage in patients with active rheumatoid arthritis who have an incomplete response to methotrexate.

Recruitment & Eligibility

Status: ot Recruiting

Sex: All

Target Recruitment: 950

Inclusion Criteria

A diagnosis of adult-onset RA (of at least six months duration but not longer then 15 years prior to Screening) as defined by the 1987 American College of Rheumatology classification criteria.

Active RA disease at Screening and Baseline as defined as =9 tenderjoints, =9 swollen joints and fulfilling one of the following two criteria, namely, =30mm/hour ESR (Westergren) or CRP> 15 mg/L.

Must have received treatment with MTX (with or without folic acid) for at least six months prior to Baseline visit. The dose of MTX must have been stable for at least two months prior to Baseline visit. The minimum dose of MTX is equivalent to 10 mg weekly.
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) yes
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

A diagnosis of any other inflammatory arthritis e.g. psoriatic arthritis or ankylosing spondylitis.

A secondary, non-inflammatory type arthritis (e.g. OA or fibromyalgia) that in the Investigator's opinion is symptomatic enough to interfere with evaluation of the effect of CDP870 on the patient's primary diagnosis of RA.

Does not meet any of the concomitant medication criteria (see protocol, section 3.3.2).

A history of chronic infection, recent serious or life-threatening infection (within 6 months, including herpes zoster), or any current sign or symptom that my indicate an infection (e.g. fever, cough).

A history of tuberculosis (TB) or positive chest X-ray for TB or positive (defined as positive induration per local medical practice) PPD skin test. Patients with a positive PPD skin test associated with previous vaccination where there is no clinical or radiographic suspicion of TB may be enrolled at the discretion of the Investigator.

NB: Consideration should be given to the fact that a positive PPD skin test with prior vaccination does not exclude latent TB.

A history of an adverse reaction to PEG or a protein medicinal product.

Study & Design

Study Type: Interventional clinical trial of medicinal product

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: To assess the efficacy of 2 dose regimens of CDP870 in combination with methotrexate compared to methotrexate alone in:<br>1. The treatment of signs and symptoms in patients with active rheumatoid arthritis (RA).<br>2. The prevention of structural damage in patients with RA.;Secondary Objective: To assess the 2 dose regimens of CDP870 in combination with MTX compared to MTX<br>alone in:<br>1. The safety and tolerability in patients with active RA.<br>2. Improving physical function in patients with active RA.<br>3. Achieving a major clinical response in patients with active RA.<br>4. Health Outcome Measures in patients with active RA.<br>5. Assessing the pharmacokinetic profile and immunogenicity of 2 dose regimens of<br>CDP870 in combination with methotrexate.;Primary end point(s): ACR20 responder rate at week 24.<br>Change from baseline in Modified Total Sharp Score at week 52.

Secondary Outcome Measures