Overview

This trial is active, not recruiting.

Condition rheumatoid arthritis
Treatment abt-494
Phase phase 2
Sponsor AbbVie
Start date January 2014
End date June 2017
Trial size 470 participants
Trial identifier NCT02049138, 2013-003530-33, M13-538

Summary

This is a Phase 2, multicenter, open-label extension study in RA subjects.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Endpoint classification safety/efficacy study
Intervention model single group assignment
Masking open label
Primary purpose treatment
Arm
(Experimental)
All subjects will start treatment with ABT-494.
abt-494
Capsule

Primary Outcomes

Measure
American College Rheumatology (ACR) 20 Response Rate
time frame: Up to Week 264
ACR 50 Response Rate
time frame: Up to Week 264
ACR 70 Response Rate
time frame: Up to Week 264
Change in Tender Joint Count
time frame: From Week 0 to Week 264
Change in Swollen Joint Count
time frame: From Week 0 to Week 264
Change in Patient's Assessment of Pain
time frame: From Week 0 to Week 264
Change in Patient's Global Assessment of Disease Activity
time frame: From Week 0 to Week 264
Change in High-Sensitivity C-Reactive Protein (hsCRP)
time frame: From Week 0 to Week 264
Change in Health Assessment Questionnaire Disability Index
time frame: From Week 0 to Week 264
Proportion of subjects achieving Low Disease Activity
time frame: Up to Week 264
Proportion of subjects achieving Clinical Remission
time frame: Up to Week 264
Change in DAS28 [CRP]
time frame: From Week 0 to Week 264
Change in CDAI
time frame: From Week 0 to Week 264
Change in Functional Assessment of Chronic Illness Therapy - Fatigue (FACIT-F) Scale
time frame: From Week 0 to Week 264
Change in Work Instability Scale - Rheumatoid Arthritis (RA-WIS)
time frame: From Week 0 to Week 264
Change in EQ-5D
time frame: From Week 0 to Week 264
Incidence of Adverse Events
time frame: Up to 30 day follow-up visit (30 days after last dose of study drug)
Change in Vital Signs
time frame: From Week 0 to 30 day follow-up visit (30 days after the last dose of study drug)
Change in Physical Examination
time frame: From Week 0 through 30 day follow-up visit (30 days after last dose of study drug)
Change in Clinical Laboratory Data
time frame: From Week 0 through 30 day follow-up visit (30 days after last dose of study drug)

Eligibility Criteria

Male or female participants from 18 years up to 100 years old.

Inclusion Criteria: 1. Subjects who have completed Study M13-550 or Study M13-537 with ABT-494 and has not developed any discontinuation criteria. 2. If the subject has evidence of new latent Tuberculosis (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: 1. Tubal ligation 2. Partner vasectomy (at least 6 months earlier) (the vasectomized male partner should be the sole partner for that female subject) 3. Intrauterine device 4. A male condom with spermicidal jelly or cream 5. Diaphragm, contraceptive sponge or cervical cap with spermicidal jelly or cream 6. 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. 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 × Upper Limit of Normal (ULN) - Estimated glomerular filtration rate by simplified 4-variable Modification of Diet in Renal Disease (MDRD) formula < 40mL/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.

Additional Information

Official title 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
Trial information was received from ClinicalTrials.gov and was last updated in October 2016.
Information provided to ClinicalTrials.gov by AbbVie.