Arthritis, Rheumatoid Arthritis
Conditions
Keywords
CDP6038
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.
Interventions
BIOLOGICALCDP6038
Single dose: 1 mg/kg CDP6038 IV
OTHERPlacebo IV
Single dose: Placebo IV
OTHERPlacebo SC
Single dose: Placebo SC
DRUGCDP 6038 SC
Optimized CDP6038 SC doses based on outcome of Cohort 1 with placebo
DRUGMethotrexate
Individual stable doses of methotrexate.
Sponsors
UCB Pharma
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
BASIC_SCIENCE
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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
| Measure | Time frame |
|---|---|
| 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 |
Countries
Germany, United States
Outcome results
None listed