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Clinical Trials/NCT01223911
NCT01223911
Completed
Phase 2

A Randomised, Double-blind, Placebo-controlled, Multiple Dose Trial of NNC 0151-0000-0000 in Subjects With Rheumatoid Arthritis

Novo Nordisk A/S1 site in 1 country34 target enrollmentJanuary 2011

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).

Registry
clinicaltrials.gov
Start Date
January 2011
End Date
February 2013
Last Updated
9 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Sponsor

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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