A Study in Rheumatoid Arthritis Patients Who Have Completed a Preceding Study With ABBV-105 Given Alone or in Combination With Upadacitinib.

• Register: ClinicalTrials.gov
• Last refreshed on: 12 December 2020
• Main ID: NCT03823378
• Date of registration: 08/01/2019
• Prospective Registration: Yes
• Primary sponsor: AbbVie
• Public title: A Study in Rheumatoid Arthritis Patients Who Have Completed a Preceding Study With ABBV-105 Given Alone or in Combination With Upadacitinib.
• Scientific title: 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)
• Date of first enrolment: May 13, 2019
• Target sample size: 97
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/show/NCT03823378
• Study type: Interventional
• Study design: Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor).
• Phase: Phase 2

Countries of recruitment

Belgium, Canada, Czechia, Hungary, Poland, Spain, United Kingdom

Contacts

• Name: AbbVie Inc.
• Affiliation: AbbVie

Key inclusion & exclusion criteria

Inclusion Criteria:

- Participant has completed M16-063.

- Participant has not developed any laboratory or clinical discontinuation criteria as
defined in M16-063.

- Participant is willing and/or able to comply with procedures required in protocol.

Exclusion Criteria:

- Participant is currently enrolled or planning to enroll in another interventional
clinical study while participating in this study (except the preceding study M16-063).

- Participant requires vaccination with any live vaccine during study participation,
including at least 30 days after the last dose of study drug.



Age minimum: 18 Years
Age maximum: N/A
Gender: All

Health Condition(s) or Problem(s) studied

Rheumatoid Arthritis (RA)

Intervention(s)

Drug: Upadacitinib placebo

Drug: ABBV-105 placebo

Drug: ABBV-105

Drug: Upadacitinib

Primary Outcome(s)

Number of Participants with Adverse Events (AEs) [Time Frame: Up to Week 60]

Secondary Outcome(s)

Change in Physician Global Assessment of Disease Activity (PhGA) from Baseline of Study M16-063 [Time Frame: Up to Week 60]

Change in Clinical Disease Activity Index (CDAI) from Baseline of Study M16-063 [Time Frame: Up to Week 60]

Change in Health Assessment Questionnaire Disability Index (HAQ-DI) from Baseline of Study M16-063 [Time Frame: Up to Week 60]

Percentage of Participants Achieving CR based on CDAI Criteria [Time Frame: Up to Week 60]

Percentage of Participants Achieving DAS Low Disease Activity (LDA) [Time Frame: Up to Week 60]

Percentage of Participants Achieving LDA based on CDAI Criteria [Time Frame: Up to Week 60]

American College of Rheumatology (ACR) 50 Response Rate [Time Frame: Up to Week 60]

Change in Disease Activity Score (DAS) 28 (C-reactive protein (CRP)) from Baseline of Study M16-063 [Time Frame: Up to Week 60]

Change in Patient's Assessment of Pain from Baseline of Study M16-063 [Time Frame: Up to Week 60]

Change in Swollen Joint Count (SJC) from Baseline of Study M16-063 [Time Frame: Up to Week 60]

American College of Rheumatology (ACR) 20 Response Rate [Time Frame: Up to Week 60]

Change in Tender Joint Count (TJC) from Baseline of Study M16-063 [Time Frame: Up to Week 60]

American College of Rheumatology (ACR) 70 Response Rate [Time Frame: Up to Week 60]

Change in Morning Stiffness from Baseline of Study M16-063 [Time Frame: Up to Week 60]

Change in Patient Global Assessment of Disease Activity (PtGA) from Baseline of Study M16-063 [Time Frame: Up to Week 60]

Change in High-Sensitivity C-Reactive Protein (hs-CRP) from Baseline of Study M16-063 [Time Frame: Up to Week 60]

Percentage of Participants Achieving DAS Clinical Remission (CR) [Time Frame: Up to Week 60]

Secondary ID(s)

2018-002306-31

M16-763

Source(s) of Monetary Support

Please refer to primary and secondary sponsors