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Randomized, Double-blind, Placebo-controlled, Dose Ranging Study With an Active Comparator to Evaluate the Efficacy and Safety of CDP6038 Administered Subcutaneously for 12 Weeks to Subjects With Rheumatoid Arthritis Having Previously Failed TNF-blocker Therapy

Phase 2
18 Years
Not Enrolling
Rheumatoid Arthritis

Thank you

Trial Information

Randomized, Double-blind, Placebo-controlled, Dose Ranging Study With an Active Comparator to Evaluate the Efficacy and Safety of CDP6038 Administered Subcutaneously for 12 Weeks to Subjects With Rheumatoid Arthritis Having Previously Failed TNF-blocker Therapy

CDP6038 is a protein (antibody) that blocks interleukin-6 (IL-6), a substance involved in
the inflammation associated with rheumatoid arthritis. This is a multicenter, 12-week,
randomized, double-blind, placebo- and active- controlled study comparing several doses and
dosage regimens (every 2 weeks and every 4 weeks) of CDP6038 to placebo and tocilizumab in
patients with active rheumatoid arthritis who have had an unsuccessful response to
methotrexate and previous anti-TNF therapy. The study will test if CDP6038 is more
efficacious than placebo in reducing the signs and symptoms of rheumatoid arthritis at 12
weeks while maintaining an adequate safety profile. In order to maintain the study blinding
all subjects will be given a subcutaneous (sc) injection (under the skin) every 2 weeks, as
well as an intravenous (iv) infusion every 4 weeks. In addition subjects must remain on
stable weekly doses of methotrexate. Assessments during the study include evaluations of
joint pain and swelling, laboratory blood and urine tests, physical examinations, vital
signs, electrocardiograms, and questionnaires. Subjects who complete the 12-week study will
be eligible to enroll in a long-term extension study receiving CDP6038.

Inclusion Criteria:

- Have a diagnosis of rheumatoid arthritis (according to the 1987 ACR classification
criteria OR a score of ≥6 as defined by the ACR/European League Against Rheumatism
Classification and Diagnostic Criteria for rheumatoid arthritis ) for at least 6
months prior to screening

- Must have been treated with MTX 12.5-25 mg/week, for at least 6 weeks prior to
screening. Doses of 10 to < 12.5mg/week are allowed if there is documented

- Have moderately to severely active rheumatoid arthritis disease with at least 6
tender and 6 swollen joints

- CRP ≥1.2 times the upper limit of normal (central laboratory) or erythrocyte
sedimentation rate of more than 28mm/hour

- Intolerant or inadequate response to treatment (ie, TNF blocker failure)≥1 licensed
TNF-blocker therapies within 2 years of screening

Exclusion Criteria:

- Have a diagnosis of any other inflammatory arthritis or secondary, noninflammatory
type of arthritis, such as psoriatic arthritis, lupus, gout, or ankylosing

- Wheelchair bound or bedridden.

- Disease modifying antirheumatic drugs (DMARDs) other than MTX.

- Treatment with tocilizumab or any other anti-IL-6 investigational therapies at any

- Treatment with other biologics within 4-24 weeks (depending on the biologic)

- History of ongoing, chronic or recurrent infections or recent serious or
life-threatening infection

- Known concurrent acute or chronic viral hepatitis B or C infection or human
immunodeficiency virus (HIV) infection.

- Vaccinations (other than injectable influenza or pneumococcal) within 8 weeks prior
to screening or plan to receive vaccines during the study

- Concurrent or history of malignancy with the exception of nonmelanoma skin cancer
successfully treated more than 2 years prior to screening or cervical cancer
successfully treated more than 5 years prior to screening.

- History of chronic alcohol abuse or drug addiction within the last 1 year or current
drug addiction or use of illicit drugs.

Type of Study:


Study Design:

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Factorial Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Outcome Measure:

Change from Baseline in the Disease Activity Score (C-reactive protein) [DAS28(CRP)] for CDP6038 and placebo

Outcome Time Frame:

Baseline, Week 12

Safety Issue:


Principal Investigator

UCB Clinical Trial Call Center

Investigator Role:

Study Director

Investigator Affiliation:

+1 877 822 9493 (UCB)


Belgium: Federal Agency for Medicinal Products and Health Products

Study ID:




Start Date:

November 2010

Completion Date:

June 2012

Related Keywords:

  • Rheumatoid Arthritis
  • Rheumatoid Arthritis
  • CDP6038
  • Interleukin-6
  • Tocilizumab
  • Arthritis
  • Arthritis, Rheumatoid



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