A Phase 2 Study to Investigate the Safety and Efficacy of ABBV-105 Given Alone or in Combination with Upadacitinib (ABBV-599 Combination) with a Background of Conventional Synthetic DMARDs in Subjects with Active Rheumatoid Arthritis with Inadequate Response or Intolerance to Biologic DMARDs

AbbVie Deutschland GmbH & Co. KG0 sites240 target enrollmentJanuary 22, 2019

ConditionsRheumatoid Arthritis MedDRA version: 20.0Level: HLTClassification code 10039075Term: Rheumatoid arthritis and associated conditionsSystem Organ Class: 100000004870 Therapeutic area: Body processes [G] - Immune system processes [G12]

Overview

Phase: Phase 1
Intervention: Not specified
Conditions: Rheumatoid Arthritis
Sponsor: AbbVie Deutschland GmbH & Co. KG
Enrollment: 240
Status: Active, not recruiting
Last Updated: 5 years ago

Overview Investigators Eligibility Criteria Outcomes Similar Trials

Overview

Brief Summary

No summary available.

Registry

who.int

Start Date

January 22, 2019

End Date

TBD

Last Updated

5 years ago

Study Type

Interventional clinical trial of medicinal product

Sex

All

Investigators

Sponsor

AbbVie Deutschland GmbH & Co. KG

Eligibility Criteria

Inclusion Criteria

•\- Adult male or female, at least 18 years old.
•\- Diagnosis of RA for \= 3 months based on the 2010 ACR/EULAR classification criteria for RA.
•\- Subject meets the following minimum disease activity criteria:
•\= 6 swollen joints (based on 66 joint counts) and \= 6 tender joints (based on 68 joint counts) at Screening and Baseline Visits (Appendix E); and
•hsCRP \= 3 mg/L (central lab) at Screening Visit.
•\- Subjects must have been treated for \= 3 months with \= 1 bDMARD therapy but continue to exhibit active RA or had to discontinue due to intolerability or toxicity, irrespective of treatment duration
•\- Subjects must have discontinued all bDMARDs prior to the first dose of study drug. The washout period for bDMARDs prior to the first dose of study drug is specified below or should be at least five times the mean terminal elimination half\-life of a drug:
•\= 4 weeks for etanercept;
•\= 10 weeks for adalimumab, infliximab, certolizumab, golimumab, and tocilizumab;
•\= 1 year for rituximab OR \= 6 months if B cells have returned to pretreatment level or normal reference range (central lab) if pretreatment levels are not available.

Exclusion Criteria

•\- History of any of the following cardiovascular conditions:
•Moderate to severe congestive heart failure (New York Heart Association Class III or IV)
•Recent history (within past 6 months) cerebrovascular accident (CVA), myocardial infarction, coronary stenting
•Uncontrolled hypertension as defined by a persistent systolic blood pressure (BP) \> 160 mmHg or diastolic BP \> 100 mmHg. For subjects with known hypertension, the subject's BP must be stable for at least 4 weeks on current, stable anti\-hypertensive medications
•Prior unprovoked deep vein thrombosis (DVT) or pulmonary embolism (PE) (i.e., any spontaneous event not directly attributable to trauma or vascular instrumentation)
•Any other condition which, in the opinion of the Investigator, would put the subject at risk by participating in the protocol.
•\- Treated with intra\-articular, intramuscular, intravenous, trigger point or tender point, intra\-bursa, or intra\-tendon sheath corticosteroids in the preceding 8 weeks prior to the first dose of study drug.
•\- Treated with any investigational drug within 30 days or five half\-lives of the drug (whichever is longer) prior to the first dose of study drug or is currently enrolled in another clinical study.
•\- Receipt of any live vaccine within 4 weeks prior to the first dose of study drug, or expected need of live vaccination during study participation including at least 4 weeks after the last dose of oral study drug
•\- Any active or recurrent viral infection that, based on the Investigator's clinical assessment, makes the subject an unsuitable candidate for the study, including hepatitis B virus (HBV) or hepatitis C virus (HCV), recurrent or disseminated (even a single episode) herpes zoster, disseminated (even a single episode) herpes simplex, or human immunodeficiency virus (HIV).