Rheumatoid arthritis MedDRA version: 13.1 Level: PT Classification code 10039073 Term: Rheumatoid arthritis System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders
Conditions
Sponsors
Wyeth Pharmaceuticals Inc. Acting through its division Wyeth Research, a Pfizer Company
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Subjects must have completed study 3242K1-2000-WW or 3242K1-2001-JA and have had no events that, in the opinion of the investigator, would preclude entry or participation in this study. 2. All women of childbearing potential (WOCBP) as determined during the previous study (data must be available as source documents for this study) must have a negative urine pregnancy test result at the baseline visit and throughout the duration of the study (defined as the time of the signing of the ICF through the conclusion of subject participation). - Women of nonchildbearing potential (WONCBP) as determined during the previous study do not require a urine pregnancy test. 3. WOCBP who have sexual intercourse with a non-surgically sterilized male partner must agree and commit to the use of the following highly effective and reliable forms of contraception: hormone contraception, double-barrier contraception (eg, condom with spermicide), or an intrauterine device for the duration of the study and for 8 weeks after the last dose of investigational product. - To be considered surgically sterilized, a male partner must have had a vasectomy at least 24 weeks before the baseline visit. All men (unless surgically sterile, as defined above) and WOCBP who have sexual intercourse must agree and commit to use a highly effective and reliable form of contraception, as stated above, for the duration of the study and for 8 weeks after the last dose of investigational product. 4. Willingness and ability to participate in all aspects of the study, including SC administration of the investigational product (by study personnel), completion of subject assessments, attending scheduled clinic visits, and compliance with all protocol requirements as evidenced by written informed consent. 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 255 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 5
Exclusion criteria
Exclusion criteria: 1. Pregnant or nursing women. 2. Any major illness/condition or evidence of an unstable clinical condition (eg, renal, hepatic, cardiovascular, hematological, gastrointestinal, endocrine, pulmonary, immunologic [eg, Felty syndrome, human immunodeficiency virus (HIV) infection], infectious, neurological, or cerebral psychiatric disease, or evidence of demyelinating disease) that, in the investigator’s judgment, will substantially increase the risk associated with the subject’s developing an adverse event (AE) or serious adverse event (SAE) during the study, or preclude the evaluation of the subject’s response. 3. Other clinically important abnormalities on the baseline physical examination or vital sign measurements (performed at week 20 in the previous study) or, any unresolved clinically significant abnormalities on laboratory tests prior to the week 20 visit. 4. Received any prohibited treatment during the previous study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To evaluate the long-term safety and tolerability of ATN-103 administered SC to subjects with RA.;Secondary Objective: There are no pre-defined secondary objectives. Exploratory analyses are planned as described in the protocol.;Primary end point(s): There is no pre-defined primary endpoint. The primary objective is to evaluate the long-term safety and tolerability of ATN-103 administered SC to subjects with RA. As such, a number of safety parameters will be evaluated over the period of the clinical trial.;Timepoint(s) of evaluation of this end point: Exploratory Analysis throughout the study | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): Not applicable;Timepoint(s) of evaluation of this end point: Exploratory analysis throughout the study | — |
Countries
Belgium, Canada, Germany, Hungary, Japan, Russian Federation, South Africa, Switzerland, United States
Contacts
Public ContactClinical Trials.gov Call Center
Pfizer Inc.
Outcome results
None listed