A Phase 2, Multicenter, Double-Blind, Parallel Group Long Term Extension Study in Rheumatoid Arthritis Subjects Who Have Completed a Preceding Phase 2 Randomized Controlled Trial with ABBV-105 Given Alone or in Combination with Upadacitinib (ABBV-599)

INTERVENTION: Product Code: ABBV‐105 Pharmaceutical Form: Capsule INN or Proposed INN: ABBV‐105 CAS Number: 1643570‐24‐4 Current Sponsor code: ABBV‐105 Other descriptive name: ABBV‐105 Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 5‐ Pharmaceutical form of the placebo: Capsule Route of administration of the placebo: Oral use Product Code: ABBV‐105 Pharmaceutical Form: Capsule INN or Proposed INN: ABBV‐105 CAS Number: 1643570‐24‐4 Current Sponsor code: ABBV‐105 Other descriptive name: ABBV‐105 Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 20‐ Pharmaceutical form of the placebo: Capsule Route of administration of the placebo: Oral use Product Name: Upadacitinib Product Code: ABT‐494 Pharmaceutical Form: Film‐coated tablet INN or Proposed INN: Upadacitinib CAS Number: 1310726‐60‐3 Current Sponsor code: ABT‐494 Other descriptive name: ABT‐494 Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 15‐ Pharmaceutical form of the placebo: Film‐coated tablet Route of administration of the placebo: Oral use CONDITION: Rheumatoid Arthritis ; MedDRA version: 20.0 Level: HLT Classification code 10039075 Term: Rheumatoid arthritis and associated conditions System Organ Class: 100000004870 Therapeutic area: Body processes [G] ‐ Immune system processes [G12] PRIMARY OUTCOME: Main Objective: The primary objective of this study is to evaluate the long‐term safety, tolerability, and efficacy of ABBV‐105 and ABBV‐599 in RA subjects who have completed Study M16‐063. Primary end point(s): Change in disease activity score (DAS)28 (C‐reactive protein [CRP]) from baseline of Study M16‐063. Secondary Objective: n/a Timepoint(s) of evaluation of this end point: Week 12/Baseline, Week 18, Week 24, Week 30, Week 36, Week 48, Week 60/Premature Discontinuation. SECONDARY OUTCOME: ; Secondary end point(s): Proportion of subjects achieving DAS Low Disease Activity (LDA), defined as DAS28 CRP =3.2;; Proportion of subjects achieving DAS Clinical Remission (CR), defined as DAS28 CRP < 2.6;; Proportion of subjects achieving American College of Rheumatology (ACR) 20/50/70 response.; Timepoint(s) of evaluation of this end point: Week 12/Baseline, Week 18, Week 24, Week 30, Week 36, Week 48, Week 60/Premature Discontinuation. 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. Females must not be pregnant, breastfeeding, or considering becoming pregnant during the study or for approximately 30 days after the last dose of study drug. For all females of child‐bearing potential: a negative serum pregnancy test at the Screening Visit and a negative urine pregnancy test at baseline prior to the first dose of study drug in the M16‐063 study as well as persistently negative urine pregnancy test throughout M16‐063 and at entrance into this study. Female subjects of childbearing potential must practice at least 1 protocol‐specified method of birth control that is effective from Study Day 1 through at least 30 days. If required per local practices, male or female condom with or without spermicide OR cap