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

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.

Study Overview

• Status: Completed
• Conditions: Arthritis; Rheumatoid Arthritis
• Intervention / Treatment: Biological: CDP6038; Biological: CDP6038; Biological: CDP6038; Other: Placebo IV; Drug: Methotrexate; Other: Placebo SC; Drug: CDP 6038 SC

Detailed Description

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.

• Study Type: Interventional
• Enrollment (Actual): 40
• Phase: Phase 2; Phase 1

Contacts and Locations

Study Locations

• Germany
  • Berlin, Germany
  • Cologne, Germany
  • Erlangen, Germany
• United States
  • Pennsylvania
    • Duncansville, Pennsylvania, United States
  • Texas
    • Dallas, Texas, United States
    • San Antonio, Texas, United States

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 75 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Basic Science
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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.	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; Drug: Methotrexate; Individual stable doses of methotrexate.
Experimental: 1 mg/kg CDP6038 SC and Placebo SC; Cohort 1, Group 2 will compare 1mg/kg CDP6038 and placebo sc.	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; Drug: Methotrexate; Individual stable doses of methotrexate.; Other: Placebo SC; Single dose: 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.	Drug: Methotrexate; Individual stable doses of methotrexate.; Drug: CDP 6038 SC; Optimized CDP6038 SC doses based on outcome of Cohort 1 with placebo

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
PK/PD relationship between systemic CDP6038 exposure and CRP suppression.	For 12 weeks following single dose
Evaluate the safety and tolerability of single doses of CDP6038 For 12 weeks following single dose	For 12 weeks following single dose

Secondary Outcome Measures

Outcome Measure	Time Frame
Absolute bioavailability of CDP6038 given by sc injection in comparison with iv infusion	For 12 weeks following single dose
Assess the immunogenicity of single dose CDP6038	Multiple sampling from 0 to 12 weeks following single dose
Assess, on an exploratory basis, changes in clinical response and other systemic biomarkers associated with RA	For 12 weeks following single dose

Collaborators and Investigators

• Sponsor: UCB Pharma
• Investigators: Study Director: UCB Clinical Trial Call Center, +1 877 822 9493 (UCB)

Study record dates

Study Major Dates

• Study Start (Actual): October 1, 2009
• Primary Completion (Actual): September 1, 2010
• Study Completion (Actual): September 1, 2010

Study Registration Dates

• First Submitted: November 4, 2009
• First Submitted That Met QC Criteria: November 4, 2009
• First Posted (Estimated): November 6, 2009

Study Record Updates

• Last Update Posted (Actual): November 15, 2024
• Last Update Submitted That Met QC Criteria: November 12, 2024
• Last Verified: November 1, 2024

More Information

Terms related to this study

• Keywords: CDP6038
• Additional Relevant MeSH Terms: Musculoskeletal Diseases; Joint Diseases; Rheumatic Diseases; Connective Tissue Diseases; Autoimmune Diseases; Immune System Diseases; Arthritis; Arthritis, Rheumatoid; Antineoplastic Agents; Immunosuppressive Agents; Immunologic Factors; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Enzyme Inhibitors; Antirheumatic Agents; Abortifacient Agents, Nonsteroidal; Abortifacient Agents; Reproductive Control Agents; Antimetabolites, Antineoplastic; Antimetabolites; Dermatologic Agents; Folic Acid Antagonists; Nucleic Acid Synthesis Inhibitors; Methotrexate
• Other Study ID Numbers: RA0010; 2009-010813-57 (EudraCT Number)