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

UCB

Status and phase: Completed; Phase 2; Phase 1

Conditions: Arthritis; Rheumatoid Arthritis

Treatments: Biological: CDP6038; Drug: CDP 6038 SC; Other: Placebo SC; Other: Placebo IV; Drug: Methotrexate

Study type: Interventional

Funder types: Industry

Identifiers

NCT01009242

RA0010

2009-010813-57 (EudraCT Number)

Details and patient eligibility

About

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.

Full 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.

Enrollment: 40 patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No 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

Trial design

Primary purpose: Basic Science

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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40 participants in 3 patient groups

0.1mg/kg and 1mg/kg CDP6038 IV and Placebo IV

Experimental group

Description:

Cohort 1, Group 1 will compare 0.1mg/kg, 1mg/kg CDP6038 and placebo IV.

Treatment:

Drug: Methotrexate

Biological: CDP6038

Other: Placebo IV

Biological: CDP6038

Biological: CDP6038

1 mg/kg CDP6038 SC and Placebo SC

Experimental group

Description:

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

Treatment:

Drug: Methotrexate

Biological: CDP6038

Biological: CDP6038

Other: Placebo SC

Biological: CDP6038

Optimized CDP6038 SC

Experimental group

Description:

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

Treatment:

Drug: Methotrexate

Drug: CDP 6038 SC