To Evaluate the Blood Levels and Safety of IV and Subcutaneous CDP6038 in Subjects With Rheumatoid Arthritis Using Methotrexate

Official Title: “A Multicenter, Randomized, Double-Blind, Placebo-Controlled, Single Dose Evaluation of the Pharmacokinetics, Pharmacodynamics and Safety of IV and Subcutaneous CDP6038 in Subjects With Rheumatoid Arthritis on a Stable Dose of 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.

The secondary objectives of the study include determination of the absolute bioavailability of CDP6038 given via sc administration compared with iv infusion; assessment of the immunogenicity potential of single dose CDP6038 and assessment, on an exploratory basis, of other relevant systemic biomarkers and changes in clinical response.

Intervention(s) in this Clinical Trial

• Biological: CDP6038
  • Single dose: 1 mg/kg CDP6038 IV
• Biological: CDP6038
  • Single dose: 0.1mg/kg CDP6038 IV
• Biological: CDP6038
  • Single dose: 1.0mg/kg CDP6038 SC
• Other: Placebo IV
  • Single dose: Placebo IV
• Other: Placebo SC
  • Single dose: Placebo SC
• Drug: CDP 6038 SC
  • Optimized CDP6038 SC doses based on outcome of Cohort 1 with placebo

Arms, Groups and Cohorts in this Clinical Trial

• Experimental: 0.1mg/kg and 1mg/kg CDP6038 IV and Placebo IV
  • Cohort 1, Group 1 will compare 0.1mg/kg, 1mg/kg CDP6038 and placebo IV.
• Experimental: 1 mg/kg CDP6038 SC and Placebo SC
  • Cohort 1, Group 2 will compare 1mg/kg CDP6038 and placebo sc.
• Experimental: Optimized CDP6038 SC
  • Cohort 2, Group 3 will compare optimized sc doses of CDP6038 based on outcome of Cohort 1 with placebo.

Primary Measures

• PK/PD relationship between systemic CDP6038 exposure and CRP suppression.
  • Time Frame: For 12 weeks following single dose
    Safety Issue?: Yes
• Evaluate the safety and tolerability of single doses of CDP6038 For 12 weeks following single dose
  • Time Frame: For 12 weeks following single dose
    Safety Issue?: Yes

Secondary Measures

• Absolute bioavailability of CDP6038 given by sc injection in comparison with iv infusion
  • Time Frame: For 12 weeks following single dose
    Safety Issue?: No
• Assess the immunogenicity of single dose CDP6038
  • Time Frame: Multiple sampling from 0 to 12 weeks following single dose
    Safety Issue?: No
• Assess, on an exploratory basis, changes in clinical response and other systemic biomarkers associated with RA
  • Time Frame: For 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 with defined agents and durations
• Previous treatment with defined agents and durations
• 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 Investigator: UCB, Inc. Industry

Overall Clinical Trial Officials and Contacts

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

Information obtained from ClinicalTrials.gov on February 09, 2012

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