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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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16 December 2017 |
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Main ID: |
NCT01223911 |
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Date of registration:
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14/10/2010 |
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Prospective Registration:
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Yes |
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Primary sponsor: |
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Public title:
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A Multiple Dose Trial of NNC 0151-0000-0000 in Subjects With Rheumatoid Arthritis
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Scientific title:
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A Randomised, Double-blind, Placebo-controlled, Multiple Dose Trial of NNC 0151-0000-0000 in Subjects With Rheumatoid Arthritis |
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Date of first enrolment:
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January 2011 |
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Target sample size:
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34 |
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Recruitment status: |
Completed |
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URL:
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https://clinicaltrials.gov/show/NCT01223911 |
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Study type:
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Interventional |
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Study design:
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Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: Double (Participant, Investigator).
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Phase:
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Phase 2
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Countries of recruitment
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Czech Republic
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Denmark
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Hungary
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Poland
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Romania
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United Kingdom
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Contacts
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Name:
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Global Clinical Registry (GCR, 1452) |
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Address:
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Telephone:
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Email:
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Affiliation:
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Novo Nordisk A/S |
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Key inclusion & exclusion criteria
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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)
Age minimum:
18 Years
Age maximum:
75 Years
Gender:
All
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Health Condition(s) or Problem(s) studied
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Inflammation
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Rheumatoid Arthritis
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Intervention(s)
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Drug: NNC 0151-0000-0000
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Drug: placebo
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Primary Outcome(s)
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Number of adverse events (AEs)
[Time Frame: at all scheduled visits (week 1 - week 11)]
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Secondary Outcome(s)
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Serum concentrations of NNC 151-0000-0000
[Time Frame: at 48 hours after all dose administrations]
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Secondary ID(s)
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NN8209-3607
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2009-011791-30
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U1111-1116-2430
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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