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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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EUCTR |
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Last refreshed on:
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25 November 2019 |
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Main ID: |
EUCTR2009-011791-30-GB |
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Date of registration:
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14/10/2009 |
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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 randomised, double-blind, placebo-controlled, 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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14/04/2010 |
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Target sample size:
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48 |
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Recruitment status: |
Not Recruiting |
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URL:
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https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2009-011791-30 |
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Study type:
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Interventional clinical trial of medicinal product |
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Study design:
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Controlled: yes
Randomised: yes
Open: no
Single blind: no
Double blind: yes
Parallel group: yes
Cross over: no
Other: no
If controlled, specify comparator, Other Medicinial Product: no
Placebo: yes
Other: no
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Phase:
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Human pharmacology (Phase I): no
Therapeutic exploratory (Phase II): yes
Therapeutic confirmatory - (Phase III): no
Therapeutic use (Phase IV): no
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Countries of recruitment
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Czech Republic
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Denmark
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Germany
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Hungary
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Poland
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Romania
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Russian Federation
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Ukraine
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United Kingdom
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Contacts
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Key inclusion & exclusion criteria
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Inclusion criteria:
• A diagnosis of rheumatoid arthritis according to the American College of Rheumatology (ACR1987 classification), made at least three months prior to randomisation.
• Active RA, characterized by a DAS28 score =3.2
• Male and female subjects
• Age between 18 and 75 years (both inclusive)
• Subjects are on stable doses of methotrexate (up to and including 25 mg/week) for at least 4 weeks prior to dosing
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range
Exclusion criteria:
1. Known or suspected allergy to trial product or related products
2. Subjects with chronic inflammatory autoimmune disease other than RA (except secondary Sjögren's syndrome or stable hypothyroidism)
3. History of or current inflammatory joint disease other than RA (eg. gout (crystal proven), psoriatic, juvenile arthritis), current reactive arthritis or Lyme disease
4. Body mass index (BMI) <18.0 or >38.0 kg/m² (inclusive)
5. Chronic or ongoing active infectious disease requiring systemic anti-infectious treatment within 2 weeks prior to randomisation
6. History of severe systemic bacterial, viral or fungal infections within the past 12 months prior to randomisation
Age minimum:
Age maximum:
Gender:
Female: yes
Male: yes
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Health Condition(s) or Problem(s) studied
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Rheumatoid arthritis
MedDRA version: 14.1
Level: PT
Classification code 10039073
Term: Rheumatoid arthritis
System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders
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Intervention(s)
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Product Name: NNC151-0000
Product Code: NNC0151-0000-0000
Pharmaceutical Form: Powder for solution for injection
Current Sponsor code: NNC0151-0000-0000
Other descriptive name: Anti-C5aR
Concentration unit: mg/ml milligram(s)/millilitre
Concentration type: equal
Concentration number: 100-
Pharmaceutical form of the placebo: Solution for injection
Route of administration of the placebo: Subcutaneous use
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Primary Outcome(s)
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Secondary Objective: To assess the pharmacodynamics of NNC151-0000 (PD) including
- C5aR occupancy on neutrophils and monocytes
- effect on various biomarkers, including acute phase cytokines and immunophenotyping
• to assess the PK of NNC151-0000
• to assess the preliminary clinical improvement and efficacy of NNC151-0000 in subjects with RA using the ACR20/50/70 and ACR-N scores and DAS28.
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Main Objective: To assess the safety and tolerability, including immunogenicity, of NNC151-0000 after four multiple doses at up to seven dose levels in subjects with active RA.
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Primary end point(s): Adverse events (AEs) and toxicity (by use of National Cancer Institute’s CTCAE scale, version 3 including
- local tolerability at injection site
- vital signs (blood pressure (BP), pulse and body temperature) and body weight
- ECG
- haematology, biochemistry including CRP, Hs-CRP and lipids, urinalysis
- acute phase cytokine response (IL-1ß, IL-6, TNF-a, INF-?)
- complement markers (e.g. C5a-desArg, C3 and total haemolytic complement titre (CH50)
- immunogenicity (antibodies to NNC151-0000). The Immunogenicity samples will be analysed at Novo Nordisk A/S. The analysis for antibodies will be performed after completion of each dose level during dose escalation.
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Secondary ID(s)
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NN8209-3607
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Source(s) of Monetary Support
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Ethics review
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Status: Approved
Approval date:
Contact:
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