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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1/PHASE2

Total Enrollment

40 participants

Study Classification

INTERVENTIONAL

Study Start Date

2009-10-31

Study Completion Date

2010-09-30

Brief Summary

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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.

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Detailed Description

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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

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Arthritis Rheumatoid Arthritis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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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.

Group Type EXPERIMENTAL

CDP6038

Intervention Type BIOLOGICAL

Single dose:

1 mg/kg CDP6038 IV

CDP6038

Intervention Type BIOLOGICAL

Single dose:

0.1mg/kg CDP6038 IV

Placebo IV

Intervention Type OTHER

Single dose:

Placebo IV

Methotrexate

Intervention Type DRUG

Individual stable doses of methotrexate.

1 mg/kg CDP6038 SC and Placebo SC

Cohort 1, Group 2 will compare 1mg/kg CDP6038 and placebo sc.

Group Type EXPERIMENTAL

CDP6038

Intervention Type BIOLOGICAL

Single dose:

1.0mg/kg CDP6038 SC

Placebo SC

Intervention Type OTHER

Single dose:

Placebo SC

Methotrexate

Intervention Type DRUG

Individual stable doses of methotrexate.

Optimized CDP6038 SC

Cohort 2, Group 3 will compare optimized sc doses of CDP6038 based on outcome of Cohort 1 with placebo.

Group Type EXPERIMENTAL

CDP 6038 SC

Intervention Type DRUG

Optimized CDP6038 SC doses based on outcome of Cohort 1 with placebo

Methotrexate

Intervention Type DRUG

Individual stable doses of methotrexate.

Interventions

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CDP6038

Single dose:

1 mg/kg CDP6038 IV

Intervention Type BIOLOGICAL

CDP6038

Single dose:

0.1mg/kg CDP6038 IV

Intervention Type BIOLOGICAL

CDP6038

Single dose:

1.0mg/kg CDP6038 SC

Intervention Type BIOLOGICAL

Placebo IV

Single dose:

Placebo IV

Intervention Type OTHER

Placebo SC

Single dose:

Placebo SC

Intervention Type OTHER

CDP 6038 SC

Optimized CDP6038 SC doses based on outcome of Cohort 1 with placebo

Intervention Type DRUG

Methotrexate

Individual stable doses of methotrexate.

Intervention Type DRUG

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No