A Study to Compare ABT-494 Monotherapy to Methotrexate Monotherapy in Subjects with Rheumatoid Arthritis (RA) Who have not Previously taken Methotrexate (SELECT-EARLY)

Phase 1

• Conditions: Moderately to Severely Active Rheumatoid Arthritis (RA); MedDRA version: 19.0Level: PTClassification code 10039073Term: Rheumatoid arthritisSystem Organ Class: 10028395 - Musculoskeletal and connective tissue disorders; Therapeutic area: Diseases [C] - Immune System Diseases [C20]

• Registration Number: EUCTR2015-003334-27-RO
• Lead Sponsor: AbbVie Deutschland GmbH & Co. KG

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2016-06-28
• Last Update Posted: 24 January 2022

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: 975

Inclusion Criteria

• Adult male or female, at least 18 years old.
• Diagnosis of RA for = 3 months.
• Naïve to MTX or, if already on MTX, have received no more than 3 weekly MTX doses with requirement to complete a 4-week MTX washout before the first dose of study drug.
• Subjects with prior exposure to conventional synthetic disease modifying anti-rheumatic drugs (csDMARDs) other than MTX may be enrolled if completed the washout period.
• Subject meets the following 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.
• = 1 bone erosion on x-ray (by local reading) OR in the absence of a documented bone erosion, both positive rheumatoid factor and positive anti-cyclic citrullinated peptide autoantibodies are required at Screening.
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 731
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 244

Exclusion Criteria

• Intolerant to MTX.
• Prior exposure to any JAK inhibitor (including but not limited to tofacitinib, baricitinib, and filgotinib).
• Prior exposure to any bDMARD(s).
• 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