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. |
Register:
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EUCTR |
Last refreshed on:
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18 March 2013 |
Main ID: |
EUCTR2011-002275-41-CZ |
Date of registration:
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28/12/2011 |
Prospective Registration:
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Yes |
Primary sponsor: |
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Public title:
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A Study of Two Different Adalimumab Formulations in Adults with
Rheumatoid Arthritis.
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Scientific title:
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A Multicenter, Randomized, Single-Blind Crossover Study of the Safety and Tolerability of Two Adalimumab Formulations in Adult Subjects with Rheumatoid Arthritis.
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Date of first enrolment:
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15/03/2012 |
Target sample size:
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60 |
Recruitment status: |
Not Recruiting |
URL:
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https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2011-002275-41 |
Study type:
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Interventional clinical trial of medicinal product |
Study design:
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Controlled: yes
Randomised: yes
Open: no
Single blind: yes
Double blind: no
Parallel group: no
Cross over: yes
Other: no
If controlled, specify comparator, Other Medicinial Product: yes
Placebo: no
Other: no
Number of treatment arms in the trial: 2
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Phase:
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Countries of recruitment
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Belgium
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Czech Republic
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Contacts
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Name:
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EU Clinical Trials Helpdesk
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Address:
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Abbott House, Vanwall Business Park
SL6 4XE
Maidenhead, Berkshire
United Kingdom |
Telephone:
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+441628644475 |
Email:
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euclinicaltrials@abbott.com |
Affiliation:
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Abbott Laboratories |
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Name:
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EU Clinical Trials Helpdesk
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Address:
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Abbott House, Vanwall Business Park
SL6 4XE
Maidenhead, Berkshire
United Kingdom |
Telephone:
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+441628644475 |
Email:
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euclinicaltrials@abbott.com |
Affiliation:
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Abbott Laboratories |
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Key inclusion & exclusion criteria
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Inclusion criteria: 1. Subject must be a current, on-label user of Humira who rates his/her average Humira injection site related pain (in the last month) as at least 3 cm on a pain Visual Analogue Scale and has had at least 6 consecutive doses of Humira prior to Screening, or a biologic-naïve subject who requires initiation of on-label treatment with Humira.
2. Male and Female subjects over 18 who require adalimumab for RA
3. Subject has diagnosis of RA as defined by the 1987 revised ACR classifcation criteria.
4. Female subjects are either not of childbearing potential or are using
birth control.
5. Female subjects are not pregnant.
6. Subject has negative TB screening test.
7. Subjects are judged to be in good health. 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 45 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 15
Exclusion criteria: 1. Subject has been treated with an investigational product within the last 30 days or 5 half-lives which ever is longer.
2. Any infection requiring treatment with IV anti-infectives with 30 days.
3. Prior exposure to natalizumab or efalizumab.
4. History of invasive infection or demyelinatiing disease.
5. Subjects with an active viral infection.
6. Subjects with a positive Hepatitis B, HBV-DNR PCR qualitative test for HBc Ab/HBs screen.
7. Have received a live vaccine within 3 months prior to study drug
administration.
Age minimum:
Age maximum:
Gender:
Female: yes Male: yes
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Health Condition(s) or Problem(s) studied
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Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]
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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: Adalimumab Pharmaceutical Form: Solution for injection INN or Proposed INN: ADALIMUMAB CAS Number: 331731-18-1 Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 40-
Trade Name: Humira 40 mg solution for injection in pre-filled syringe Product Name: Adalimumab Pharmaceutical Form: Solution for injection INN or Proposed INN: ADALIMUMAB CAS Number: 331731-18-1 Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 40-
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Primary Outcome(s)
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Main Objective: Compare the injection site related pain profile of two different formulations of Humira immediately after injection.
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Primary end point(s): Compare the injection site related pain profile of two different formulations of Humira immediately after injection.
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Timepoint(s) of evaluation of this end point: Subjects will receive a dose of each formulation of Humira two weeks apart.
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Secondary Objective: Compare the safety and injection site reaction adverse events between the 2 formulations.
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Secondary Outcome(s)
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Secondary end point(s): Compare the safety and injection site reaction adverse events between the two different formulations of Humira.
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Timepoint(s) of evaluation of this end point: Subjects will receive a dose of each formulation of Humira two weeks apart.
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Source(s) of Monetary Support
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Abbott Laboratories
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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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