Moderately to Severely Active Rheumatoid Arthritis (RA) MedDRA version: 23.1 Level: PT Classification code 10039073 Term: Rheumatoid arthritis System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders
Conditions
Interventions
Product Name: Upadacitinib 3mg
Pharmaceutical Form: Capsule
INN or Proposed INN: Upadacitinib
CAS Number: 1310726-60-3
Current Sponsor code: ABT 494
Concentration unit: mg milligram(s)
Concentration t
Sponsors
AbbVie Deutschland GmbH & Co. KG
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Subjects who have completed Study M13-550 or Study M13-537 with upadacitinib 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 30 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
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Timepoint(s) of evaluation of this end point: • Weeks 6, 12, 24, 36, 48, 60, 72, 84, 96, 108, 120, 132, 144, 156, 168, 180, 192, 204, 216, 228, 240, 252, 264, 276, 288, 300, 312 and 30 day follow up visit • For AE's: Week 0 through 30 day follow-up visit (30 days after last dose of study drug);Secondary Objective: Not applicable;Main Objective: Main Study: To evaluate the long-term safety, tolerability, and efficacy of upadacitinib in RA subjects who have completed Study M13-550 or Study M13-537 Phase 2 RCT with upadacitinib. Optional Vaccine Sub-study: To assess the impact of upadacitinib treatment (15 mg QD or 30 mg QD) with a stable background of MTX on immunological responses following administration of Prevnar 13 pneumococcal vaccine in RA patients.;Primary end point(s): • ACR 20/50/70 response rates • Change from Baseline in individual ACR components: Tender Joint Count, Swollen Joint Count, Patient’s Assessment of Pain (VAS), Patient’s Global Assessment of Disease Activity, Physician’s Global Assessment of Disease Activity, hsCRP, and health Assessment Questionnaire Disability Index (HAQ-DI) • Proportion of subjects achieving Low Disease Activity or Clinical Remission, and the Proportion of subjects achieving Clinical Remission. • Change from Baseline in DAS28 [CRP] disease activity score, CDAI and Patient Reported Outcomes including FACIT-Fatigue Scale, RA-WIS, and EQ-5D • Incidence of adverse events, changes in vital signs, physical examination results and clinical laboratory data | — |
Countries
Belgium, Bulgaria, Chile, Czech Republic, European Union, Hungary, Israel, Latvia, Mexico, Netherlands, New Zealand, Puerto Rico, Russian Federation, South Africa, Spain, Ukraine, United Kingdom, United States
Contacts
Public ContactEU Clinical Trials Helpdesk
AbbVie Ltd
Outcome results
None listed