A Study Comparing Upadacitinib (ABT-494) to Placebo and to Adalimumab in Subjects with Rheumatoid Arthritis who are on a Stable Dose of Methotrexate and Who Have an Inadequate Response to Methotrexate (SELECT-COMPARE)

Phase 1

• Conditions: Moderately to Severely Active Rheumatoid Arthritis (RA); MedDRA version: 20.0Level: PTClassification code 10039073Term: Rheumatoid arthritisSystem Organ Class: 10028395 - Musculoskeletal and connective tissue disorders; Therapeutic area: Diseases [C] - Immune System Diseases [C20]

• Registration Number: EUCTR2015-003333-95-HR
• Lead Sponsor: AbbVie Deutschland GmbH & Co. KG

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2016-04-28
• Last Update Posted: 11 June 2018

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: 1500

Inclusion Criteria

• Adult male or female, at least 18 years old.
• Diagnosis of RA for = 3 months.
• Subjects must have been on oral or parenteral MTX therapy = 3 months prior to the first dose of study drug.
• Subjects meeting both: = 6 swollen joints and = 6 tender joints at screening and baseline, and hsCRP = 5 mg/L at screening
• At least one of the following at Screening: = 3 bone erosions on x-ray OR = 1 bone erosion and a positive rheumatoid factor OR = 1 bone erosion and a positive anti-cyclic citrullinated peptide autoantibodies.
• Subjects with prior exposure to at most one bDMARD (except ADA) may be enrolled (up to 20% of total study population)
• Except for MTX, subject must have discontinued all conventional synthetic disease-modifying anti-rheumatic drugs (csDMARDs).

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 1125
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 375

Exclusion Criteria

• Prior exposure to any Janus kinase (JAK) inhibitor (including but not limited to tofacitinib, baricitinib, and filgotinib).
• Subjects who are considered inadequate responders to bDMARD therapy
• History of inflammatory joint disease other than RA. History of secondary Sjogren's Syndrome is permitted.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified