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Clinical Trials/NCT01282255
NCT01282255
Completed
Phase 2

A Randomised, Double Blind, Placebo-controlled, Multiple Dose Trial of Anti-IL-20 (109-0012) in Subjects With Rheumatoid Arthritis

Novo Nordisk A/S1 site in 1 country67 target enrollmentFebruary 2011
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ConditionsInflammationRheumatoid Arthritis
InterventionsNNC109-0012placebo

Overview

Phase
Phase 2
Intervention
NNC109-0012
Conditions
Inflammation
Sponsor
Novo Nordisk A/S
Enrollment
67
Locations
1
Primary Endpoint
Change in DAS28-CRP (disease activity score 28 calculated with C-reactive protein value)
Status
Completed
Last Updated
9 years ago
OverviewInvestigatorsEligibility CriteriaArms & InterventionsOutcomesSitesSimilar Trials

Overview

Brief Summary

This trial is conducted in Europe. The aim of this trial is to evaluate the change in disease activity following 12 weekly s.c. (under the skin) doses of NNC109-0012 compared to placebo in subjects with active Rheumatoid Arthritis (RA).

Registry
clinicaltrials.gov
Start Date
February 2011
End Date
January 2012
Last Updated
9 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Sponsor

Eligibility Criteria

Inclusion Criteria

  • •Czech Republic: Age between 18 - 65 years (both inclusive)
  • •A diagnosis of RA made at least 3 months prior to trial start
  • •Active RA
  • •Methotrexate treatment (between 7.5 mg and 25 mg/week, both inclusive) for at least 12 weeks with a stable dose for at least 4 weeks prior to trial start
  • •Female subjects must be willing to avoid pregnancy and breast feeding throughout this trial at least until 15 weeks following the last dose of trial medication
  • •Male subjects with partners of childbearing potential must be willing to use a highly effective contraception throughout trial incl. a 15 week follow up periode

Exclusion Criteria

  • •Known or suspected allergy to trial product or related products
  • •Body Mass Index (BMI) lower than 18.5 or higher than 35.0 kg/m\^2
  • •Subjects with chronic inflammatory autoimmune disease other than RA (except secondary Sjögren's syndrome or stable hypothyroidism)

Arms & Interventions

A

Intervention: NNC109-0012

B

Intervention: placebo

Outcomes

Primary Outcomes

Change in DAS28-CRP (disease activity score 28 calculated with C-reactive protein value)

Time Frame: week 0, week 12

Secondary Outcomes

  • Terminal serum half-life (t½)(end of treatment period)
  • Serum levels of NNC109-0012(end of treatment period)

Study Sites (1)

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