Clinical trial NCT01009242: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
PHASE2
Conditions: Arthritis
Rheumatoid Arthritis
Keywords: CDP6038
Lead sponsor: UCB Pharma
Sponsor class: INDUSTRY
First posted: 2009-11-06
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: BASIC_SCIENCE

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.

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.

Eligibility 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

Primary outcomes:
measure: PK/PD relationship between systemic CDP6038 exposure and CRP suppression.
timeFrame: For 12 weeks following single dose
measure: Evaluate the safety and tolerability of single doses of CDP6038 For 12 weeks following single dose
timeFrame: For 12 weeks following single dose
Secondary outcomes:
measure: Absolute bioavailability of CDP6038 given by sc injection in comparison with iv infusion
timeFrame: For 12 weeks following single dose
measure: Assess the immunogenicity of single dose CDP6038
timeFrame: Multiple sampling from 0 to 12 weeks following single dose
measure: Assess, on an exploratory basis, changes in clinical response and other systemic biomarkers associated with RA
timeFrame: For 12 weeks following single dose
Other outcomes:
Locations:
city: Duncansville
country: United States
state: Pennsylvania
city: Dallas
country: United States
state: Texas
city: San Antonio
country: United States
state: Texas
city: Berlin
country: Germany
city: Cologne
country: Germany
city: Erlangen
country: Germany
Study officials:
affiliation: +1 877 822 9493 (UCB)
name: UCB Clinical Trial Call Center
role: STUDY_DIRECTOR
References: