An Open-label Extension Study Evaluating the Safety and Efficacy of Upadacitinib (ABT-494) in Rheumatoid Arthritis Subjects
a study on Rheumatoid Arthritis
This is a Phase 2, multicenter, open-label extension study in RA subjects. The sub-study is to assess the impact of upadacitinib treatment (15 mg QD and 30 mg QD) with background MTX on immunological responses to Prevnar 13® in RA patients.
A 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 Upadacitinib (ABT-494)
Rheumatoid ArthritisMusculoskeletal DiseaseArthritisJoint DiseasesAnti-inflammatory AgentsAntirheumatic agentsArthritis, RheumatoidUpadacitinibABT-494Open-label extension
You can join if…
Open to people ages 18-100
- Subjects who have completed Study M13-550 or Study M13-537 with Upadacitinib (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.
- Must currently be enrolled in the main study.
- Must have been receiving a stable dose of upadacitinib (either 15 mg QD or 30 mg QD) for a minimum of 4 weeks prior to the Vaccination visit.
- Must have been on a stable dose of background methotrexate (no change in dose or frequency) for a minimum of 4 weeks prior to the Vaccination visit.
- If subject is on corticosteroids, must remain on a stable dose of ≤ 10 mg/day of prednisone or equivalent corticosteroid therapy for at least 4 weeks after the vaccination visit.
- Must meet the prescribing specifications as per local label requirements to receive Prevnar 13® vaccine.
- Willing to receive Prevnar13® vaccine.
You CAN'T join if...
- 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 (local requirements may apply) 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.
- Consideration by the investigator, for any reason, that the subject is an unsuitable candidate to receive study drug.
- Receiving any csDMARDs other than MTX
- Receiving > 10 mg/day of prednisone or equivalent corticosteroid therapy.
- Receipt of any steroid injection within 4 weeks prior to Vaccination visit.
- History of severe allergic reaction (e.g., anaphylaxis) to any component of Prevnar 13®.
- History of any documented pneumococcal infection within the last 6 months prior to the vaccination visit.
- Receipt of any vaccine 4 weeks prior to the vaccination visit and/or anticipation of any vaccination for 4 weeks after the vaccination visit.
- Receipt of any pneumococcal vaccine.
- Subject is not suitable for the sub-study as per the Investigator's judgment.
- Ucsd /Id# 128747
La JollaCalifornia92037United States
- C.V. Mehta MD, Med Corporation /ID# 124092
- in progress, not accepting new patients
- Start Date
- Completion Date
- Phase 2
- Study Type
- Last Updated