A Study of Two Different Adalimumab Formulations in Adults withRheumatoid Arthritis.

Conditions: Rheumatoid Arthritis.
MedDRA version: 14.1Level: PTClassification code 10039073Term: Rheumatoid arthritisSystem Organ Class: 10028395 - Musculoskeletal and connective tissue disorders
Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]

Registration Number: EUCTR2011-002275-41-BE

Lead Sponsor: Abbott GmbH & Co. KG

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: ot Recruiting

Sex: All

Target Recruitment: 60

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.

Study & Design

Study Type: Interventional clinical trial of medicinal product

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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<br>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 Measures

Name	Time	Method
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.

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