A Multiple Dose Trial of NNC 0151-0000-0000 in Subjects With Rheumatoid Arthritis
NCT ID: NCT01223911
Last Updated: 2017-02-09
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE2
34 participants
INTERVENTIONAL
2011-01-31
2013-02-28
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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A
NNC 0151-0000-0000
Multiple doses will be administered subcutaneously (under the skin), one dose once weekly during a three week period
B
placebo
Multiple doses will be administered subcutaneously (under the skin), one dose once weekly during a three week period
Interventions
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NNC 0151-0000-0000
Multiple doses will be administered subcutaneously (under the skin), one dose once weekly during a three week period
placebo
Multiple doses will be administered subcutaneously (under the skin), one dose once weekly during a three week period
Eligibility Criteria
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Inclusion Criteria
* 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
* Body mass index (BMI) less than 18.0 or more than 38.0 kg/m2 (inclusive)
18 Years
75 Years
ALL
No
Sponsors
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Novo Nordisk A/S
INDUSTRY
Responsible Party
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Principal Investigators
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Global Clinical Registry (GCR, 1452)
Role: STUDY_DIRECTOR
Novo Nordisk A/S
Locations
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Novo Nordisk Investigational Site
Prague, , Czechia
Novo Nordisk Investigational Site
Frederiksberg, , Denmark
Novo Nordisk Investigational Site
Silkeborg, , Denmark
Novo Nordisk Investigational Site
Budapest, , Hungary
Novo Nordisk Investigational Site
Bialystok, , Poland
Novo Nordisk Investigational Site
Elblag, , Poland
Novo Nordisk Investigational Site
Krakow, , Poland
Novo Nordisk Investigational Site
Poznan, , Poland
Novo Nordisk Investigational Site
Bacau, Bacău, Romania
Novo Nordisk Investigational Site
Cluj-Napoca, Cluj, Romania
Novo Nordisk Investigational Site
Sfântu Gheorghe, Covasna, Romania
Novo Nordisk Investigational Site
Bucharest, , Romania
Novo Nordisk Investigational Site
Bucharest, , Romania
Novo Nordisk Investigational Site
Burslem, , United Kingdom
Novo Nordisk Investigational Site
Newcastle upon Tyne, , United Kingdom
Novo Nordisk Investigational Site
Swansea, , United Kingdom
Countries
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References
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Daniluk S, Skrumsager BK, Leszczynski P. Safety and tolerability of the anti-C5aR humanised monoclonal antibody NNC0151-0000 in patients with rheumatoid arthritis: A phase 2, randomised, double-blind, placebocontrolled, multiple-dose trial. EULAR (European League Against Rheumatism) 2014; Country: France City: Paris
Related Links
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Clinical Trials at Novo Nordisk
Other Identifiers
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U1111-1116-2430
Identifier Type: OTHER
Identifier Source: secondary_id
2009-011791-30
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
NN8209-3607
Identifier Type: -
Identifier Source: org_study_id
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