Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
Register:
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EUCTR |
Last refreshed on:
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19 March 2018 |
Main ID: |
EUCTR2015-003332-13-IT |
Date of registration:
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28/02/2018 |
Prospective Registration:
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No |
Primary sponsor: |
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Public title:
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A Study Comparing ABT-494 to Placebo in Subjects with Rheumatoid Arthritis on a Stable Dose of Conventional Synthetic Disease-Modifying Antirheumatic Drugs (csDMARDs) Who have an Inadequate Response to csDMARDs Alone (SELECT-NEXT)
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Scientific title:
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A Phase 3, Randomized, Double-Blind Study Comparing ABT-494 to Placebo in Subjects with Moderately to Severely Active Rheumatoid Arthritis Who Are on a Stable Dose of Conventional Synthetic Disease-Modifying Anti-Rheumatic Drugs (csDMARDs) and Have an Inadequate Response to csDMARDs - SELECT-NEXT |
Date of first enrolment:
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15/04/2016 |
Target sample size:
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600 |
Recruitment status: |
Not Recruiting |
URL:
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https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2015-003332-13 |
Study type:
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Interventional clinical trial of medicinal product |
Study design:
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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: no Placebo: yes Other: no Number of treatment arms in the trial: 4
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Phase:
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Human pharmacology (Phase I): no
Therapeutic exploratory (Phase II): no
Therapeutic confirmatory - (Phase III): yes
Therapeutic use (Phase IV): no
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Countries of recruitment
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Argentina
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Australia
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Austria
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Barbados
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Belgium
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Bosnia and Herzegovina
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Brazil
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Bulgaria
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Canada
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Chile
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Colombia
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Croatia
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Czech Republic
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Denmark
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Egypt
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European Union
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Finland
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Greece
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Hong Kong
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Hungary
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Ireland
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Israel
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Italy
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Japan
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Kazakhstan
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Korea, Democratic People's Republic of
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Korea, Republic of
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Latvia
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Lithuania
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Malaysia
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Mexico
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New Zealand
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Norway
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Poland
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Portugal
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Puerto Rico
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Russian Federation
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Serbia
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Singapore
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Slovakia
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South Africa
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Spain
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Switzerland
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Taiwan
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Turkey
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Ukraine
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United Kingdom
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United States
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Contacts
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Name:
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EU Clinical Trials Helpdesk
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Address:
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AbbVie House, Vanwall Business Park, Vanwall
SL6 4UB
Maidenhead, Berkshire
United Kingdom |
Telephone:
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0044 1628 561090 |
Email:
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eu-clinical-trials@abbvie.com |
Affiliation:
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AbbVie Ltd |
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Name:
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EU Clinical Trials Helpdesk
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Address:
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AbbVie House, Vanwall Business Park, Vanwall
SL6 4UB
Maidenhead, Berkshire
United Kingdom |
Telephone:
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0044 1628 561090 |
Email:
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eu-clinical-trials@abbvie.com |
Affiliation:
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AbbVie Ltd |
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Key inclusion & exclusion criteria
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Inclusion criteria: • Adult male or female, at least 18 years old. • Diagnosis of RA for = 3 months. • Subjects have been receiving csDMARD therapy = 3 months and on a stable dose for = 4 weeks prior to the first dose of study drug. The following csDMARDs are allowed: MTX, sulfasalazine, hydroxychloroquine, chloroquine, and leflunomide. • Meets the 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. • Subjects with prior exposure to at most one bDMARD may be enrolled (up to 20% of study population).
Are the trial subjects under 18? no Number of subjects for this age range: 1 F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 450 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 150
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. • Subjects who are considered inadequate responders to bDMARD therapy as determined by the Investigator.
Age minimum:
Age maximum:
Gender:
Female: yes Male: yes
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Health Condition(s) or Problem(s) studied
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Therapeutic area: Diseases [C] - Immune System Diseases [C20]
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Moderately to Severely Active Rheumatoid Arthritis (RA) MedDRA version: 20.0
Level: PT
Classification code 10039073
Term: Rheumatoid arthritis
System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders
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Intervention(s)
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Product Name: ABT-494 Product Code: ABT-494 Pharmaceutical Form: Tablet INN or Proposed INN: ABT-494 CAS Number: 1310726-60-3 Current Sponsor code: ABT-494 Other descriptive name: ABT-494 Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 30- Pharmaceutical form of the placebo: Tablet
Product Name: ABT-494 Pharmaceutical Form: Tablet INN or Proposed INN: ABT-494 CAS Number: 1310726-60-3 Current Sponsor code: ABT-494 Other descriptive name: N.A. Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 15- Pharmaceutical form of the placebo: Tablet
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Primary Outcome(s)
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Primary end point(s): The primary endpoint is the proportion of subjects achieving ACR20 response / the proportion of subjects achieving LDA at Week 12.
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Timepoint(s) of evaluation of this end point: week 12
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Main Objective: • To compare the efficacy of ABT-494 versus placebo for the treatment of signs and symptoms of subjects with moderately to severely active rheumatoid arthritis (RA) who are on a stable dose of conventional synthetic disease-modifying anti-rheumatic drugs (csDMARDs) and have an inadequate response to csDMARDs. • To compare the safety and tolerability of ABT-494 versus placebo in subjects with moderately to severely active RA who are on a stable dose of csDMARDs and have an inadequate response to csDMARDs. • To evaluate the long-term safety, tolerability, and efficacy of ABT-494 in subjects with RA.
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Secondary Objective: Not applicable
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Secondary Outcome(s)
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Timepoint(s) of evaluation of this end point: week 12
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Secondary end point(s): Change from baseline in Disease Activity Score (DAS) 28 (C-reactive protein [CRP]) • Change from baseline in HAQ-DI • ACR 50 response rate • ACR 70 response rate • Change from baseline in Short Form-36 (SF-36) Physical Component Score (PCS) • Proportion of subjects achieving Clinical remission (CR) based on DAS28 (CRP) • Change from baseline in Functional Assessment of chronic Illness Therapy-Fatigue (FACIT-F) • Change from baseline in Work Stability Scale for Rheumatoid Arthritis (FA-WIS) • Change from baseline in morning stiffness (severity).
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Secondary ID(s)
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M13-549
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N.A.
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2015-003332-13-SK
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Source(s) of Monetary Support
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AbbVie Inc.
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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