Rheumatoid Arthritis. MedDRA version: 14.1 Level: PT Classification code 10039073 Term: Rheumatoid arthritis System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders
Conditions
Sponsors
Abbott GmbH & Co. KG
Eligibility
Sex/Gender
All
Inclusion 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
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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
| Measure | Time frame |
|---|---|
| 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. | — |
Countries
Belgium, Czech Republic
Contacts
Public ContactEU Clinical Trials Helpdesk
Abbott Laboratories
Outcome results
None listed