Official Title: “A Multicenter, Randomized, Double-Blind, Placebo-Controlled, Single Dose Study of the Pharmacokinetics (PK), Pharmacodynamics (PD) and Safety of Intravenous and Subcutaneous CDP6038 in Subjects With Rheumatoid Arthritis on Stable Methotrexate”

The primary objectives are to determine the relationship between blood levels of CDP6038 and suppression of C-reactive Protein (CRP) following single doses given as intravenous (IV) infusion or subcutaneous (SC) injection to Rheumatoid Arthritis (RA) patients. The safety of CDP6038 will also be evaluated.

Study Type: Interventional

Study Design: Basic Science, Randomized, Double Blind (Subject, Investigator), Single Group Assignment, Pharmacokinetics/Dynamics Study

Study Primary Completion Date: June 2010

Intervention(s) in this Clinical Trial

• Biological: CDP6038
  • Single dose: 0.1mg/kg IV
• Biological: CDP6038
  • Single dose: 1.0mg/kg IV
• Biological: CDP6038
  • Single dose: 1.0mg/kg SC
• Biological: CDP6038
  • Single dose: Optimized dose IV to be decided on outcome of cohort 1
• Biological: CDP6038
  • Single dose: Optimized dose SC to be decided on outcome of cohort 1
• Biological: CDP6038
  • Single dose: Optimized dose SC or IV to be decided on outcome of cohort 1
• Other: Placebo IV
  • Single dose: Placebo IV
• Other: Placebo SC
  • Single dose: Placebo SC

Arms, Groups and Cohorts in this Clinical Trial

• Placebo Comparator: Placebo IV
  • Placebo IV
• Placebo Comparator: Placebo SC
  • Placebo SC
• Experimental: CDP6038 0.1mg/kg IV
  • CDP6038 0.1mg/kg IV
• Experimental: CDP6038 1.0mg/kg IV
  • CDP6038 1.0mg/kg IV
• Experimental: CDP6038 1.0mg/kg SC
  • CDP6038 1.0mg/kg SC
• Experimental: CDP6038 optimized dose IV
  • CDP6038 optimized dose IV
• Experimental: CDP6038 optimized dose SC
  • CDP6038 optimized dose SC
• Experimental: CDP6038 optimized dose IV or SC
  • CDP6038 optimized dose IV or SC

Primary Measures

• Parameters characterizing the pharmacokinetic/pharmacodynamic relationship between CDP6038 exposure and C-reactive protein suppression following intravenous & subcutaneous administration.
  • Time Frame: Multiple sampling from 0 to 12 weeks following single dose
    Safety Issue?: No

Secondary Measures

• The absolute bioavailability of CDP6038 given via subcutaneous administration compared to intravenous infusion.
  • Time Frame: Multiple sampling from 0 to 12 weeks following single dose
    Safety Issue?: No
• Assess the immunogenicity of CDP6038 (percentage of patients with titers above the cut-off)
  • Time Frame: Multiple sampling from 0 to 12 weeks following single dose
    Safety Issue?: No

Inclusion Criteria:

• RA > 6 months duration on stable Methotrexate
• ≤9 swollen and ≤9 tender joints (28 joint count)
• Minimum Screening CRP of 0.5mg/L

Exclusion Criteria:

• Participation in previous studies including biologics within 5 half lives
• Previous treatment with etanercept, anakinra, golimumab, infliximab, adalimumab, certolizumab pegol, abatacept, B cell depleting therapy tocilizumab or other anti
• IL-6 preparations for defined durations prior to study
• Presence of, or history of defined medical conditions including those particularly associated with deficiency in immune response
• Pregnancy
• Positive tests/signs of possible latent/active tuberculosis
• Positive HIV
• Drug addiction or alcohol abuse

Gender Eligibility for this Clinical Trial: Both

Minimum Age for this Clinical Trial: 18 Years

Maximum Age for this Clinical Trial: 75 Years

Are Healthy Volunteers Accepted for this Clinical Trial?: No

Lead Sponsor: UCB, Inc.

Overall Clinical Trial Officials and Contacts

UCB Clinical Trial Call Center Study Director +1 877 822 9493 (UCB)  

Overall Contact: UCB Clinical Trial Call Center +1 877 822 9493 

Information obtained from ClinicalTrials.gov on February 08, 2010

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT01009242

Study ID Number: RA0010

ClinicalTrials.gov Identifier: NCT01009242

Health Authority: United States: Food and Drug Administration