A Study of Two Different Adalimumab Formulations in Adults with Rheumatoid Arthritis.

• 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

Countries of recruitment

Belgium, Czech Republic

Contacts

• Name: EU Clinical Trials Helpdesk
• Affiliation: Abbott Laboratories

• Name: EU Clinical Trials Helpdesk
• 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.

Secondary Objective: Compare the safety and injection site reaction adverse events between the 2 formulations.

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 Outcome(s)

Timepoint(s) of evaluation of this end point: Subjects will receive a dose of each formulation of Humira two weeks apart.

Secondary end point(s): Compare the safety and injection site reaction adverse events between the two different formulations of Humira.

Secondary ID(s)

M12-783

Source(s) of Monetary Support

Abbott Laboratories