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

Phase 1

Completed

• Conditions: Arthritis; Rheumatoid Arthritis
• Interventions: Drug: CDP 6038 SC; Biological: CDP6038; Other: Placebo IV; Other: Placebo SC; Drug: Methotrexate

• Registration Number: NCT01009242
• Lead Sponsor: 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.

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 Timeline

• Study Start: 2009-10
• Study First Submitted: 2009-11-04
• Study First Submitted QC: 2009-11-04
• Study First Posted: 2009-11-06
• Primary Completion: 2010-09
• Study Completion: 2010-09
• Disposition First Submitted: 2011-10-03
• Disposition First Submitted QC: 2011-10-03
• Disposition First Posted: 2011-10-05
• Status Verified: 2024-11
• Last Update Submitted: 2024-11-12
• Last Update Posted: 2024-11-15

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 40

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
0.1mg/kg and 1mg/kg CDP6038 IV and Placebo IV	Placebo IV	Cohort 1, Group 1 will compare 0.1mg/kg, 1mg/kg CDP6038 and placebo IV.
1 mg/kg CDP6038 SC and Placebo SC	Placebo SC	Cohort 1, Group 2 will compare 1mg/kg CDP6038 and placebo sc.
Optimized CDP6038 SC	CDP 6038 SC	Cohort 2, Group 3 will compare optimized sc doses of CDP6038 based on outcome of Cohort 1 with placebo.
0.1mg/kg and 1mg/kg CDP6038 IV and Placebo IV	CDP6038	Cohort 1, Group 1 will compare 0.1mg/kg, 1mg/kg CDP6038 and placebo IV.
1 mg/kg CDP6038 SC and Placebo SC	CDP6038	Cohort 1, Group 2 will compare 1mg/kg CDP6038 and placebo sc.
0.1mg/kg and 1mg/kg CDP6038 IV and Placebo IV	Methotrexate	Cohort 1, Group 1 will compare 0.1mg/kg, 1mg/kg CDP6038 and placebo IV.
1 mg/kg CDP6038 SC and Placebo SC	Methotrexate	Cohort 1, Group 2 will compare 1mg/kg CDP6038 and placebo sc.
Optimized CDP6038 SC	Methotrexate	Cohort 2, Group 3 will compare optimized sc doses of CDP6038 based on outcome of Cohort 1 with placebo.

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
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