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

• Register: EUCTR
• Last refreshed on: 14 November 2016
• Main ID: EUCTR2015-003334-27-HU
• Date of registration: 10/06/2016
• Prospective Registration: Yes
• Primary sponsor: AbbVie Deutschland GmbH & Co. KG
• Public title: A Study to Compare ABT-494 Monotherapy to Methotrexate Monotherapy in Subjects with Rheumatoid Arthritis (RA) Who have not Previously taken Methotrexate (SELECT-EARLY)
• Scientific title: A Phase 3, Randomized, Double-Blind Study Comparing ABT-494 Once Daily Monotherapy to Methotrexate (MTX) Monotherapy in MTX-Naïve Subjects with Moderately to Severely Active Rheumatoid Arthritis
• Date of first enrolment: 13/07/2016
• Target sample size: 975
• Recruitment status: Authorised-recruitment may be ongoing or finished
• URL: https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2015-003334-27
• 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: no Other: no Number of treatment arms in the trial: 3
• 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, Belarus, Belgium, Bosnia and Herzegovina, Brazil, Bulgaria, Canada, Chile, China, Colombia, Croatia, Czech Republic, Egypt, European Union, Greece, Hong Kong, Hungary, Israel, Japan, Kazakhstan, Korea, Republic of, Latvia, Lithuania, Malaysia, Mexico, New Zealand, Poland, Portugal, Puerto Rico, Russian Federation, Serbia, Slovakia, Slovenia, South Africa, Spain, Switzerland, Taiwan, 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 = 6 weeks.
• 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. Current diagnosis of secondary Sjogren's Syndrome is permitted.


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

Health Condition(s) or Problem(s) studied

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

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

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: 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

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

Primary Outcome(s)

Primary end point(s): Proportion of subjects achieving Clinical Remission (CR) at Week 24.

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 with moderately to severely active RA.
• 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.
• To evaluate the long-term safety, tolerability, and efficacy of ABT-494 in subjects with RA.

Timepoint(s) of evaluation of this end point: week 24

Secondary Objective: Not applicable

Secondary Outcome(s)

Timepoint(s) of evaluation of this end point: Week 24

Secondary end point(s): Change from baseline in DAS28 (CRP)
Change from baseline in HAQ-DI
ACR20 response rate
ACR50 response rate
Change from baseline in modified Total Sharp Score (mTSS)
ACR70 response rate
Proportion of subjects achieving LDA based on DAS28 (CRP) = 3.2
Change from baseline in SF-36 PCS
Proportion of subjects with no radiographic progression (defined as change from baseline in mTSS = 0) at Weeks 24 and 48.

Secondary ID(s)

M13-545

2015-003334-27-SK

Source(s) of Monetary Support

AbbVie Inc.