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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: |
NCT00927927 |
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Date of registration:
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24/06/2009 |
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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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First-in-man Trial of NNC0142-0002 in Patients With Rheumatoid Arthritis
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Scientific title:
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A Randomized, Double-blind, Placebo-controlled, Dose-escalation, Single and Multiple Dose Trial to Investigate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of NNC0142-0002 Administered Subcutaneously to Subjects With Rheumatoid Arthritis |
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Date of first enrolment:
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June 2009 |
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Target sample size:
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65 |
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Recruitment status: |
Completed |
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URL:
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https://clinicaltrials.gov/show/NCT00927927 |
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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 1
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Countries of recruitment
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Germany
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Contacts
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Name:
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Britta Væver Bysted, DVM, PhD |
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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:
- Active rheumatoid arthritis, characterized by a Disease Activity Score (DAS28) above
3.2, and a diagnosis of at least three months duration
- Aged between 18 and 75 years (both inclusive)
- Subjects on stable doses of methotrexate for at least 4 weeks prior to dosing
- Use of highly effective contraception during the trial (both males and females)
Exclusion Criteria:
- A chronic inflammatory autoimmune or joint disease other than RA (rheumatoid
arthritis)
- An active or latent tuberculosis
- Any investigational or experimental therapy within 4 weeks or 5 half-lives (whichever
is longer) prior to the screening visit
- A known significant cardio-vascular disease
- Vaccination against live virus or bacteria within 4 weeks prior to randomization
- The use of concomitant medications that are prohibited in the trial (e.g., certain
DMARDs (antirheumatic therapies that are disease modifying), biologics (here:
biotechnologically produced antibodies), intra-articular corticoid-injections, etc.)
- A positive test result for human immunodeficiency virus (HIV) infection, hepatitis B
and/or hepatitis C, or tuberculosis skin test
- Donation of greater than or equal to 400 ml of blood within 8 weeks prior to trial
entry
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: placebo
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Drug: NNC0142-0002
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Primary Outcome(s)
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Frequency of Adverse Events
[Time Frame: Adverse events were collected for a mean (min; max) of 15.7 (6.4; 42.6) weeks for single-dose subjects, and 30.6 (12.7; 43.1) for multiple-dose subjects. Visits were scheduled until receptor occupancy was below the cut-off level for receptor positivity.]
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Secondary Outcome(s)
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Area Under the Concentration-time Curve (AUC)
[Time Frame: Data were collected from 0 hours to at least Day 43 (SD cohorts) and Day 85 (MD cohorts), and until the receptor occupancy was confirmed below the cut-off level for receptor positivity.]
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Secondary ID(s)
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2008-008703-18
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NN8555-3618
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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