A Study Comparing ABT-494 Monotherapy to Methotrexate (MTX) Monotherapy in Subjects with Rheumatoid Arthritis (RA) Who Have an Inadequate Response to MTX (SELECT-MONOTHERAPY)

• Register: EUCTR
• Last refreshed on: 4 July 2016
• Main ID: EUCTR2015-003376-75-ES
• Date of registration: 19/01/2016
• Prospective Registration: Yes
• Primary sponsor: AbbVie Deutschland GmbH & Co. KG
• Public title: A Study Comparing ABT-494 Monotherapy to Methotrexate (MTX) Monotherapy in Subjects with Rheumatoid Arthritis (RA) Who Have an Inadequate Response to MTX (SELECT-MONOTHERAPY)
• Scientific title: A Phase 3, Randomized, Double-Blind Study Comparing ABT-494 Monotherapy to Methotrexate (MTX) in Subjects with Moderately to Severely Active Rheumatoid Arthritis with Inadequate Response to MTX
• Date of first enrolment: 23/06/2016
• Target sample size: 600
• Recruitment status: Authorised-recruitment may be ongoing or finished
• URL: https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2015-003376-75
• Study type: Interventional clinical trial of medicinal product
• Study design: Controlled: yes Randomised: yes Open: no Single blind: no Double blind: yes Parallel group: yes Cross over: no Other: no If controlled, specify comparator, Other Medicinial Product: yes Placebo: yes Other: no Number of treatment arms in the trial: 4
• Phase: Human pharmacology (Phase I): no Therapeutic exploratory (Phase II): no Therapeutic confirmatory - (Phase III): yes Therapeutic use (Phase IV): no

Countries of recruitment

Argentina, Australia, Austria, Chile, Colombia, European Union, Israel, Japan, Mexico, New Zealand, Puerto Rico, Russian Federation, Serbia, Spain, Turkey, Ukraine, United States

Contacts

• Name: EU Clinical Trials Helpdesk
• Affiliation: AbbVie Ltd

• Name: EU Clinical Trials Helpdesk
• Affiliation: AbbVie Ltd

Key inclusion & exclusion criteria

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 and on a stable dose for ? 4 weeks prior to Screening.
? Must have discontinued all conventional synthetic disease-modifying anti-rheumatic drugs (csDMARDs) (other than MTX) ? 4 weeks prior to first dose of study drug.
? 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.
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 465
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 135

Exclusion criteria:
? Prior exposure to any Janus kinase (JAK) inhibitor (including but not limited to tofacitinib, baricitinib, and filgotinib).
? Prior exposure to any biological disease-modifying anti-rheumatic drugs (bDMARDs).
? History of inflammatory joint disease other than RA. History of secondary Sjogren's Syndrome is permitted.


Age minimum:
Age maximum:
Gender:
Female: yes
Male: yes

Health Condition(s) or Problem(s) studied

Therapeutic area: Diseases [C] - Immune System Diseases [C20]

Moderately to Severely Active Rheumatoid Arthritis (RA)
MedDRA version: 19.0 Level: PT Classification code 10039073 Term: Rheumatoid arthritis System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders

Intervention(s)

Product Name: ABT-494
Pharmaceutical Form: Tablet
INN or Proposed INN: ABT-494
CAS Number: 1310726-60-3
Current Sponsor code: ABT-494
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 30-
Pharmaceutical form of the placebo: Tablet
Route of administration of the placebo: Oral use

Product Name: Methotrexate
Pharmaceutical Form: Capsule
INN or Proposed INN: Methotrexate
Other descriptive name: METHOTREXATE
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 7.5-
Pharmaceutical form of the placebo: Capsule
Route of administration of the placebo: Oral use

Product Name: Methotrexate
Pharmaceutical Form: Capsule
INN or Proposed INN: Methotrexate
Other descriptive name: METHOTREXATE
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 10-
Pharmaceutical form of the placebo: Capsule
Route of administration of the placebo: Oral use

Product Name: ABT-494
Pharmaceutical Form: Tablet
INN or Proposed INN: ABT-494
CAS Number: 1310726-60-3
Current Sponsor code: ABT-494
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 15-
Pharmaceutical form of the placebo: Tablet
Route of administration of the placebo: Oral use

Primary Outcome(s)

Primary end point(s): The two primary endpoints are the proportion of subjects achieving ACR20 and low disease activity (LDA) at Week 14.

Secondary Objective: Not applicable

Timepoint(s) of evaluation of this end point: Week 14

Main Objective: ? To compare the safety and efficacy (signs and symptoms) of ABT-494 monotherapy versus MTX in MTX-inadequate response (MTX-IR) subjects with moderately to severely active rheumatoid arthritis (RA).
? To evaluate the long-term safety, tolerability, and efficacy of ABT-494 in subjects with RA.

Secondary Outcome(s)

Secondary end point(s): ? Change from baseline in Disease Activity Score (DAS) 28 (C-reactive protein [CRP])
? Change from baseline in HAQ-DI (Health Assessment Questionnaire - Disability Index)
? ACR50 response
? ACR70 response
? Change from Baseline in Short Form-36 (SF-36) Physical Component Score (PCS)
? Proportion of subjects achieving CR based on DAS28 (CRP)
? Change from baseline in morning stiffness (severity)

Timepoint(s) of evaluation of this end point: Week 14

Secondary ID(s)

M15-555

Source(s) of Monetary Support

AbbVie Inc.