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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: EUCTR
Last refreshed on: 18 March 2013
Main ID:  EUCTR2011-002275-41-CZ
Date of registration: 28/12/2011
Prospective Registration: Yes
Primary sponsor: Abbott GmbH & Co. KG
Public title: A Study of Two Different Adalimumab Formulations in Adults with Rheumatoid Arthritis.
Scientific title: A Multicenter, Randomized, Single-Blind Crossover Study of the Safety and Tolerability of Two Adalimumab Formulations in Adult Subjects with Rheumatoid Arthritis.
Date of first enrolment: 15/03/2012
Target sample size: 60
Recruitment status: Not Recruiting
URL:  https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2011-002275-41
Study type:  Interventional clinical trial of medicinal product
Study design:  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  
Phase: 
Countries of recruitment
Belgium Czech Republic
Contacts
Name: EU Clinical Trials Helpdesk   
Address:  Abbott House, Vanwall Business Park SL6 4XE Maidenhead, Berkshire United Kingdom
Telephone: +441628644475
Email: euclinicaltrials@abbott.com
Affiliation:  Abbott Laboratories
Name: EU Clinical Trials Helpdesk   
Address:  Abbott House, Vanwall Business Park SL6 4XE Maidenhead, Berkshire United Kingdom
Telephone: +441628644475
Email: euclinicaltrials@abbott.com
Affiliation:  Abbott Laboratories
Key inclusion & exclusion criteria
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
Health Condition(s) or Problem(s) studied
Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]
Rheumatoid Arthritis.
MedDRA version: 14.1 Level: PT Classification code 10039073 Term: Rheumatoid arthritis System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders
Intervention(s)

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-

Primary Outcome(s)
Main Objective: Compare the injection site related pain profile of two different formulations of Humira immediately after injection.
Primary end point(s): Compare the injection site related pain profile of two different
formulations of Humira immediately after injection.
Timepoint(s) of evaluation of this end point: Subjects will receive a dose of each formulation of Humira two weeks apart.
Secondary Objective: Compare the safety and injection site reaction adverse events between the 2 formulations.
Secondary Outcome(s)
Secondary end point(s): Compare the safety and injection site reaction adverse events between the two different formulations of Humira.
Timepoint(s) of evaluation of this end point: Subjects will receive a dose of each formulation of Humira two weeks apart.
Secondary ID(s)
M12-783
Source(s) of Monetary Support
Abbott Laboratories
Secondary Sponsor(s)
Ethics review
Results
Results available:
Date Posted:
Date Completed:
URL:
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