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 494 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

  • Subjects who have completed Study M13-550 or Study M13-537 with ABT-494 and has not developed any discontinuation criteria.
  • 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.
  • 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
  • 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.
  • 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

  • Pregnant or breastfeeding female.
  • 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.
  • Anticipated requirement or receipt of any live vaccine during study participation including up to 30 days after the last dose of study drug.
  • 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
  • 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 January 2017.
Information provided to ClinicalTrials.gov by AbbVie.