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

Sponsor

UCB Pharma (Industry)

Overall Status

Completed

CT.gov ID

NCT01009242

Collaborator

(none)

Enrollment

Locations

Arms

Actual Duration (Months)

6.7

Patients Per Site

0.6

Patients Per Site Per Month

Study Details

Study Description

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 Biological: CDP6038 Biological: CDP6038 Other: Placebo IV Other: Placebo SC Drug: CDP 6038 SC Drug: Methotrexate	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.

Study Design

Study Type:

Interventional

Actual Enrollment :

40 participants

Allocation:

Randomized

Intervention Model:

Parallel 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

Actual Study Start Date :

Oct 1, 2009

Actual Primary Completion Date :

Sep 1, 2010

Actual Study Completion Date :

Sep 1, 2010

Arms and Interventions

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 Drug: Methotrexate Individual stable doses of methotrexate.
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 Drug: Methotrexate Individual stable doses of methotrexate.
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 Drug: Methotrexate Individual stable doses of methotrexate.

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

Drug: Methotrexate

Individual stable doses of methotrexate.

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

Drug: Methotrexate

Individual stable doses of methotrexate.

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

Drug: Methotrexate

Individual stable doses of methotrexate.

Outcome Measures

Primary Outcome Measures

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

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]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 75 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Contacts and Locations

Locations

	City	State	Country
1	Duncansville	Pennsylvania	United States
2	Dallas	Texas	United States
3	San Antonio	Texas	United States
4	Berlin		Germany
5	Cologne		Germany
6	Erlangen		Germany

Sponsors and Collaborators

UCB Pharma

Investigators

Study Director: UCB Clinical Trial Call Center, +1 877 822 9493 (UCB)

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

UCB Pharma

ClinicalTrials.gov Identifier:

NCT01009242

Other Study ID Numbers:

RA0010
2009-010813-57

First Posted:

Nov 6, 2009

Last Update Posted:

Jan 27, 2020

Last Verified:

Jan 1, 2020

Keywords provided by UCB Pharma

CDP6038

Additional relevant MeSH terms:

Arthritis

Arthritis, Rheumatoid

Methotrexate

Study Results

No Results Posted as of Jan 27, 2020