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

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ClinicalTrials.gov Identifier: NCT01009242
Recruitment Status : Completed
First Posted : November 6, 2009
Last Update Posted : August 27, 2014
Sponsor:
Information provided by (Responsible Party):
UCB Pharma

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Arthritis Rheumatoid Arthritis Biological: CDP6038 Other: Placebo IV Other: Placebo SC Drug: CDP 6038 SC Phase 1 Phase 2

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 40 participants
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Basic Science
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
Study Start Date : October 2009
Actual Primary Completion Date : September 2010
Actual Study Completion Date : September 2010

Resource links provided by the National Library of Medicine


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


Other: Placebo IV

Single dose:

Placebo IV


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:

1.0mg/kg CDP6038 SC


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: CDP 6038 SC
Optimized CDP6038 SC doses based on outcome of Cohort 1 with placebo




Primary Outcome Measures :
  1. PK/PD relationship between systemic CDP6038 exposure and CRP suppression. [ Time Frame: For 12 weeks following single dose ]
  2. Evaluate the safety and tolerability of single doses of CDP6038 For 12 weeks following single dose [ Time Frame: For 12 weeks following single dose ]

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


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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01009242


Locations
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United States, Pennsylvania
Duncansville, Pennsylvania, United States
United States, Texas
Dallas, Texas, United States
San Antonio, Texas, United States
Germany
Berlin, Germany
Cologne, Germany
Erlangen, Germany
Sponsors and Collaborators
UCB Pharma
Investigators
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Study Director: UCB Clinical Trial Call Center +1 877 822 9493 (UCB)

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Responsible Party: UCB Pharma
ClinicalTrials.gov Identifier: NCT01009242     History of Changes
Other Study ID Numbers: RA0010
2009-010813-57 ( EudraCT Number )
First Posted: November 6, 2009    Key Record Dates
Last Update Posted: August 27, 2014
Last Verified: October 2011
Keywords provided by UCB Pharma:
CDP6038
Additional relevant MeSH terms:
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Arthritis
Arthritis, Rheumatoid
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases
Connective Tissue Diseases
Autoimmune Diseases
Immune System Diseases
Methotrexate
Abortifacient Agents, Nonsteroidal
Abortifacient Agents
Reproductive Control Agents
Physiological Effects of Drugs
Antimetabolites, Antineoplastic
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Dermatologic Agents
Enzyme Inhibitors
Folic Acid Antagonists
Immunosuppressive Agents
Immunologic Factors
Antirheumatic Agents
Nucleic Acid Synthesis Inhibitors