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

Phase 1

• Conditions: Moderately to Severely Active Rheumatoid Arthritis (RA); MedDRA version: 20.0Level: PTClassification code 10039073Term: Rheumatoid arthritisSystem Organ Class: 10028395 - Musculoskeletal and connective tissue disorders; Therapeutic area: Diseases [C] - Immune System Diseases [C20]

• Registration Number: EUCTR2013-003530-33-LV
• Lead Sponsor: AbbVie Deutschland GmbH & Co. KG

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2014-06-17
• Last Update Posted: 3 November 2021

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 494

Inclusion Criteria

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. Subject with new evidence of latent TB should initiate prophylactic treatment immediately per local guidelines while continuing study drug treatment. Prophylactic treatment must be completed.
3. If female, subject must be postmenopausal, OR permanently surgically sterile, OR for women of childbearing potential practicing at least one protocol-specified method of birth control (refer to Section 5.2.4), that is effective from Study Day 1 through at least 30 days after the last dose of study drug.
4. If male, and subject is sexually active with female partner(s) of childbearing potential, he must agree, from Study Day 1 through 90 days after the last dose of study drug, to practice the protocol-specified contraception (refer to Section 5.2.4).
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 354
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 140

Exclusion Criteria

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