A Study Comparing 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)

• Register: EUCTR
• Last refreshed on: 26 February 2024
• Main ID: EUCTR2015-003333-95-HU
• Date of registration: 07/04/2016
• Prospective Registration: Yes
• Primary sponsor: AbbVie Deutschland GmbH & Co. KG
• Public title: A Study Comparing 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)
• Scientific title: A Phase 3, Randomized, Double-Blind Study Comparing ABT-494 to Placebo and to Adalimumab in Subjects with Moderately to Severely Active Rheumatoid Arthritis Who are on a Stable Background of Methotrexate (MTX) and Who Have an Inadequate Response to MTX (MTX-IR)
• Date of first enrolment: 18/05/2016
• Target sample size: 1500
• Recruitment status: Not Recruiting
• URL: https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2015-003333-95
• 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: 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, Austria, Belarus, Belgium, Bosnia and Herzegovina, Brazil, Bulgaria, Canada, Chile, Colombia, Croatia, Czech Republic, Denmark, Egypt, European Union, Finland, Germany, Greece, Hong Kong, Hungary, Ireland, Israel, Kazakhstan, Korea, Republic of, Latvia, Lithuania, Malaysia, Mexico, New Zealand, Poland, Portugal, Puerto Rico, Romania, Russian Federation, Serbia, Singapore, Slovakia, South Africa, Spain, Taiwan, Turkey, Ukraine, United Kingdom, 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 prior to the first dose of study drug.
• 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).
• 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

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: 15-
Pharmaceutical form of the placebo: Tablet
Route of administration of the placebo: Oral use

Trade Name: Humira 40mg/0.8ml solution for injection in pre-filled syringe
Product Name: Adalimumab
Pharmaceutical Form: Solution for injection in pre-filled syringe
INN or Proposed INN: ADALIMUMAB
CAS Number: 331731-18-1
Concentration unit: mg/ml milligram(s)/millilitre
Concentration type: equal
Concentration number: 50-
Pharmaceutical form of the placebo: Solution for injection in pre-filled syringe
Route of administration of the placebo: Subcutaneous use

Primary Outcome(s)

Timepoint(s) of evaluation of this end point: week 12

Main Objective: • To compare the efficacy of ABT-494 QD versus placebo, and versus adalimumab (ADA) for the treatment of signs and symptoms of rheumatoid arthritis (RA) in subjects with moderately to severely active RA who are on a on a stable background of methotrexate (MTX) and who have an inadequate response to MTX (MTX-IR).
• To compare the efficacy of ABT-494 QD versus placebo for the prevention of structural progression in RA subjects with moderately to severely active RA who are on a on a stable background of MTX and who have an inadequate response to MTX (MTX-IR).
• To compare the safety and tolerability of ABT-494 QD versus placebo, and versus ADA in subjects with moderately to severely active RA subjects who are on a stable background of MTX and who have an inadequate response to MTX (MTX-IR).
• To evaluate the long-term safety, tolerability, and efficacy of ABT-494 in subjects with RA.

Primary end point(s): The primary endpoint is the proportion of subjects achieving ACR20 response at Week 12 / the proportion of subjects achieving clinical remission (CR) based on DAS28 (CRP) at Week 12

Secondary Objective: Not applicable

Secondary Outcome(s)

Secondary end point(s): • Change from baseline in modified Total Sharp Score (mTSS) at Week 26
• Proportion of subjects achieving LDA at Week 12
• Change from baseline in Disease Activity Score (DAS) 28(CRP) at Week 12
• Change from baseline in Health Assessment Questionnaire (HAQ-DI) at Week 12
• ACR50 response at Week 12
• ACR70 response at Week 12
• Proportion of subjects achieving LDA based on DAS28 (CRP) = 3.2 at Week 12
• Change from baseline in Short Form 36 (SF-36) PCS at Week 12
• Change from baseline in Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-F) at Week 12
• Proportion of subjects with no radiographic progression at Week 26
• Change from baseline in Work Stability Scale for Rheumatoid Arthritis (RA-WIS) at Week 12
• Change from baseline in morning stiffness (severity) at Week 12

Timepoint(s) of evaluation of this end point: Week 12 and Week 26

Secondary ID(s)

2015-003333-95-SK

M14-465

Source(s) of Monetary Support

AbbVie Inc.

Ethics review

Status: Approved
Approval date: 11/05/2016
Contact: