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: 18.1Level: 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-ES
• Lead Sponsor: AbbVie Deutschland GmbH & Co. KG

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2016-01-19
• Last Update Posted: 8 August 2016

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: 800

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 other than MTX may be enrolled if
completed the washout period.
? 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.
? ? 1 bone erosion on x-ray (by local reading) OR in the absence of 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 600
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 200

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

Primary Outcome Measures

Name	Time	Method
Main Objective: ? To compare the safety and efficacy of ABT-494 monotherapy versus methotrexate (MTX) monotherapy for the treatment of signs and symptoms of rheumatoid arthritis (RA) in MTX-naïve subjects.<br>? To compare the efficacy of ABT-494 monotherapy versus MTX monotherapy for prevention of structural progression in MTX-naive subjects with moderately to severely active RA.;Secondary Objective: Not applicable;Primary end point(s): ACR50 response; Low Disease Activity (LDA);Timepoint(s) of evaluation of this end point: week 24

Secondary Outcome Measures

Name	Time	Method
Secondary end point(s): ? Change from baseline in modified Total Sharp Score (mTSS);<br>? Change from baseline in Disease Activity Score (DAS) 28 (CRP);<br>? ACR70 response; <br>? Change from baseline in HAQ-DI; <br>? ACR20 response; <br>? Change from baseline in Short Form-36 (SF-36) Physical Component Score (PCS)<br>? Clinical Remission (CR);Timepoint(s) of evaluation of this end point: Week 24.