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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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19 October 2017 |
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Main ID: |
NCT01181050 |
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Date of registration:
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12/08/2010 |
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Prospective Registration:
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No |
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Primary sponsor: |
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Public title:
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Efficacy of NNC0142-0002 in Subjects With Rheumatoid Arthritis (RA)
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Scientific title:
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A Randomised, Single-dose, Double-blind, Placebo-controlled, Parallel-group Trial to Assess Clinical Efficacy of NNC0142-0002 in Subjects With Active Rheumatoid Arthritis |
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Date of first enrolment:
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August 2010 |
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Target sample size:
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63 |
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Recruitment status: |
Completed |
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URL:
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https://clinicaltrials.gov/show/NCT01181050 |
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Study type:
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Interventional |
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Study design:
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Phase:
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Phase 2
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Countries of recruitment
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Germany
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Russian Federation
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Ukraine
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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:
- A diagnosis of RA meeting the American College of Rheumatology 1987 (ACR1987)
criteria, obtained at least three months prior to dosing with the trial product
- Subjects with active RA having a Disease Activity Score (DAS28-CRP) of 4.5 or more, at
least five tender and five swollen joints (can be the same), including one swollen
wrist or at least two swollen ipsilateral metacarpophalangeal (MCP) joints (second to
fifth)
- Concomitant treatment with methotrexate (MTX) (7.5-25 mg/week) for at least 12 weeks,
with stable dose for at least 4 weeks prior to dosing
- Ability to be examined by Magnetic Resonance Imaging (MRI)
- Having failed no biologic therapies for RA and no more than two non-biologic disease
modifying antirheumatic drugs
Exclusion Criteria:
- Chronic inflammatory autoimmune disease other than RA (rheumatoid arthritis)
- Any ongoing chronic or active infectious disease or microbial infection requiring
systemic oral or intravenous treatment against infection within 1 month prior to trial
start
- Body mass index (BMI) below or equal to 18 or above or equal to 40 kg/m^2
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: NNC0142-0002
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Drug: placebo
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Primary Outcome(s)
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Change in DAS28-CRP After 12 Weeks of Treatment
[Time Frame: Week 0, Week 12]
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Secondary Outcome(s)
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Change in DAS28-CRP After 24 Weeks of Treatment.
[Time Frame: Week 0, Week 24]
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Change in DAS28-CRP After 6 Weeks of Treatment.
[Time Frame: Week 0, Week 6]
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Secondary ID(s)
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U1111-1114-9194
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2010-019261-28
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NN8555-3796
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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