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

Rheumatoid Arthritis Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01009242
• Other study ID #: RA0010
• Secondary ID: 2009-010813-57
• Status: Completed
• Phase: Phase 1/Phase 2
• Start date: October 2009
• Est. completion date: September 2010

Study information

• Verified date: January 2020
• Source: UCB Pharma
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 40
• Est. completion date: September 2010
• Est. primary completion date: September 2010
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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

Related Conditions & MeSH terms

• Arthritis
• Arthritis, Rheumatoid
• Rheumatoid Arthritis

Intervention

Biological:
• CDP6038
Single dose: 1 mg/kg CDP6038 IV
• CDP6038
Single dose: 0.1mg/kg CDP6038 IV
• CDP6038
Single dose: 1.0mg/kg CDP6038 SC

Other:
• Placebo IV
Single dose: Placebo IV
• Placebo SC
Single dose: Placebo SC

Drug:
• CDP 6038 SC
Optimized CDP6038 SC doses based on outcome of Cohort 1 with placebo
• Methotrexate
Individual stable doses of methotrexate.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
UCB Pharma

Countries where clinical trial is conducted

United States,  Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	PK/PD relationship between systemic CDP6038 exposure and CRP suppression.		For 12 weeks following single dose
Primary	Evaluate the safety and tolerability of single doses of CDP6038 For 12 weeks following single dose		For 12 weeks following single dose
Secondary	Absolute bioavailability of CDP6038 given by sc injection in comparison with iv infusion		For 12 weeks following single dose
Secondary	Assess the immunogenicity of single dose CDP6038		Multiple sampling from 0 to 12 weeks following single dose
Secondary	Assess, on an exploratory basis, changes in clinical response and other systemic biomarkers associated with RA		For 12 weeks following single dose