NCT01223911
Completed
Phase 2
A Randomised, Double-blind, Placebo-controlled, Multiple Dose Trial of NNC 0151-0000-0000 in Subjects With Rheumatoid Arthritis
Overview
- Phase
- Phase 2
- Intervention
- NNC 0151-0000-0000
- Conditions
- Inflammation
- Sponsor
- Novo Nordisk A/S
- Enrollment
- 34
- Locations
- 1
- Primary Endpoint
- Number of adverse events (AEs)
- Status
- Completed
- Last Updated
- 9 years ago
Overview
Brief Summary
This trial is conducted in Europe. The aim of this clinical trial is to investigate the safety, tolerability and pharmacokinetics (at which rate the drug is eliminated from the body) of NNC 151-0000-0000 in subjects with rheumatoid arthritis (RA).
Investigators
Eligibility Criteria
Inclusion Criteria
- •CZ: Age between 18 and 65 years (both inclusive)
- •A diagnosis of rheumatoid arthritis of at least three months before entry in trial
- •Active rheumatoid arthritis (RA)
- •Subjects are on stable doses of methotrexate (up to and including 25 mg/week) for at least 4 weeks before trial drug administration
Exclusion Criteria
- •Known or suspected allergy to trial product or related products
- •Body mass index (BMI) less than 18.0 or more than 38.0 kg/m2 (inclusive)
Arms & Interventions
A
Intervention: NNC 0151-0000-0000
B
Intervention: placebo
Outcomes
Primary Outcomes
Number of adverse events (AEs)
Time Frame: at all scheduled visits (week 1 - week 11)
Secondary Outcomes
- Serum concentrations of NNC 151-0000-0000(at 48 hours after all dose administrations)
Study Sites (1)
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