This is a Phase 2, multicenter, 24-week, open-label extension (OLE) study to assess the safety and tolerability of ABT-122 in rheumatoid arthritis (RA) subjects who have completed Study M12-963.
- Conditions
- Rheumatoid ArthritisMedDRA version: 18.1Level: PTClassification code 10039073Term: Rheumatoid arthritisSystem Organ Class: 10028395 - Musculoskeletal and connective tissue disordersTherapeutic area: Diseases [C] - Immune System Diseases [C20]
- Registration Number
- EUCTR2014-001471-31-HU
- Lead Sponsor
- AbbVie Deutschland GmbH & Co. KG
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 160
1. Subjects who have completed the preceding Study M12-963 (ABT-122) RCT study and have not developed any discontinuation criteria, as defined in Section 5.4.1 of Study M12-963.
2. If female, subject must meet one of the following criteria:
•Postmenopausal (defined as no menses for at least 1 year).
•Surgically sterile (bilateral tubal ligation, bilateral oophorectomy or hysterectomy).
•Practicing appropriate birth control, from the time of enrollment in this study until at least 150 days after the last dose of study drug.
•Females who have undergone tubal ligation will be required to agree to use a second form of contraception for the same period of time.
3. Male who agrees to follow one of the protocol-specified pregnancy avoidance measures, including refraining from donating sperm, for up to 150 days post last dose of study drug.
4. 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.
5. 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 106
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 54
1. Pregnant or breastfeeding female.
2. Ongoing infections at Week 0 that have NOT been successfully treated within 14 days.
3. Anticipated requirement or receipt of any live vaccine during study participation including up to 120 days after the last dose of study drug.
4. Current enrollment in another investigational study; with the exception of M12-963, which is required.
5. Consideration by the Investigator, for any reason, that the subject is an unsuitable candidate to receive ABT-122.
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Main Objective: The primary objective is to assess the long-term safety and tolerability of ABT-122 in subjects with rheumatoid arthritis (RA) who have completed Study M12-963 Phase 2 RCT.;Secondary Objective: -To explore the effect of continued dosing on anti-drug antibody (ADA) profiles for ABT-122<br>-To explore the influence of ABT-122 dose on maintenance of efficacy, as assessed by ACR response criteria and EULAR remission criteria and the individual components of these measures<br>-To explore the longer term effects of ABT-122 on function, quality of life, fatigue and work instability.;Primary end point(s): The primary objective is to assess the long-term safety and tolerability of ABT-122 in subjects with rheumatoid arthritis (RA) who have completed Study M12-963 Phase 2 RCT.;Timepoint(s) of evaluation of this end point: Week 24
- Secondary Outcome Measures
Name Time Method Secondary end point(s): -To explore the effect of continued dosing on anti-drug antibody (ADA) profiles for ABT-122<br>-To explore the influence of ABT-122 dose on maintenance of efficacy, as assessed by ACR response criteria and EULAR remission criteria and the individual components of these measures<br>-To explore the longer term effects of ABT-122 on function, quality of life, fatigue and work instability.;Timepoint(s) of evaluation of this end point: Week 24