NCT01009242

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

• Status: Completed
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 40 (actual)
• Sponsor: UCB Pharma · Industry
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Arthritis
• Rheumatoid Arthritis

Interventions

Type	Name	Description
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
DRUG	Methotrexate	Individual stable doses of methotrexate.

Timeline

• Start date: 2009-10-01
• Primary completion: 2010-09-01
• Completion: 2010-09-01
• First posted: 2009-11-06
• Last updated: 2024-11-15

Locations

6 sites across 2 countries: United States, Germany