Phase 2 Study, Multicenter, Open-Label Extension (OLE) Study in Rheumatoid Arthritis Subjects Who Have Completed a Preceding Phase 2 Randomized Controlled Trial (RCT) with ABT-494
- Conditions
- Moderately to Severely Active Rheumatoid Arthritis (RA)MedDRA version: 17.0Level: PTClassification code 10039073Term: Rheumatoid arthritisSystem Organ Class: 10028395 - Musculoskeletal and connective tissue disordersTherapeutic area: Diseases [C] - Immune System Diseases [C20]
- Registration Number
- EUCTR2013-003530-33-ES
- Lead Sponsor
- AbbVie Deutschland GmbH & Co. KG
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 520
1. Subjects who have completed Study M13-550 or Study M13-537 with ABT-494 and has not developed any discontinuation criteria, defined in Section 5.4.1 of that study.
2. If the subject has evidence of new latent TB infection, the subject must initiate and complete a minimum of 2 weeks (or per local guidelines, whichever is longer) of an ongoing TB prophylaxis before continuing to receive study drug.
3. If female, subject must meet one of the following criteria:
? Postmenopausal (defined as no menses for at least 1 year).
? Surgically sterile (bilateral oophorectomy or hysterectomy).
? Practicing from the time of screening until at least 30 days after the last dose of study drug at least TWO of the following methods of birth control:
- Tubal ligation
- Partner vasectomy (at least 6 months earlier) (the vasectomized male partner should be the sole partner for that female subject)
- Intrauterine device
- A male condom with spermicidal jelly or cream
- Diaphragm, contraceptive sponge or cervical cap with spermicidal jelly or cream
- Hormonal contraceptives (injected, oral, transdermal or implanted methods) must have been taking at least 2 months prior to dosing
4. Male subjects must agree to follow protocol-specified pregnancy avoidance measures, including refraining from donating sperm, for up to 30 days post last dose of study drug.
5. Subjects must voluntarily sign and date an informed consent, approved by an Independent Ethics Committee (IEC)/Institutional Review Board (IRB), prior to the initiation of any screening or study specific procedures.
6. Subject is judged to be in good health as determined by the Investigator based on the results of medical history, physical examination and laboratory profile performed.
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 390
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 130
1. Pregnant or breastfeeding female.
2. Ongoing infections at Week 0 that have NOT been successfully treated. Subjects with ongoing infections undergoing treatment may be enrolled BUT NOT dosed until the infection has been successfully treated.
3. Anticipated requirement or receipt of any live vaccine during study participation including up to 30 days after the last dose of study drug.
4. Laboratory values from the visit immediately prior to Baseline Visit meeting the following criteria:
? Serum aspartate transaminase (AST) or alanine transaminase (ALT) > 3.0 × ULN
? Estimated glomerular filtration rate by simplified 4-variable Modification of Diet in Renal Disease (MDRD) formula < 40 mL/min/1.73m2
? Total white blood cell count (WBC) < 2,000/µL
? Absolute neutrophil count (ANC) < 1,000/µL
? Platelet count < 50,000/µL
? Absolute lymphocytes count < 500/µL
? Hemoglobin < 8 gm/dL
5. Enrollment in another interventional clinical study while participating in this study.
6. Consideration by the investigator, for any reason, that the subject is an unsuitable candidate to receive study drug.
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method