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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: EUCTR
Last refreshed on: 11 May 2020
Main ID:  EUCTR2016-000933-37-BG
Date of registration: 12/01/2018
Prospective Registration: Yes
Primary sponsor: AbbVie Deutschland GmbH & Co. KG
Public title: Study to Compare Upadacitinib to Abatacept in Subjects with Rheumatoid Arthritis on Stable Dose of Conventional Synthetic Disease-Modifying Antirheumatic Drugs (csDMARDs) Who have an Inadequate Response or Intolerance to Biologic DMARDs (SELECT-CHOICE)
Scientific title: A Phase 3, Randomized, Active-Controlled, Double Blind Study Comparing Upadacitinib to Abatacept in Subjects with Moderately to Severely Active Rheumatoid Arthritis with Inadequate Response or Intolerance to Biologic DMARDs (bDMARDs) on Stable Conventional Synthetic Disease Modifying Anti-Rheumatic Drugs (csDMARDs)
Date of first enrolment: 09/05/2018
Target sample size: 550
Recruitment status: Authorised-recruitment may be ongoing or finished
URL:  https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2016-000933-37
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: yes Other specify the comparator: Abatacept Number of treatment arms in the trial: 2  
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 Brazil Bulgaria Canada Chile
Colombia Czech Republic France Germany Greece Hungary Ireland Israel
Italy Korea, Democratic People's Republic of Latvia Mexico Netherlands New Zealand Norway Poland
Portugal Puerto Rico Romania Russian Federation Slovakia Spain Sweden Switzerland
Turkey United Kingdom United States
Contacts
Name: EU Clinical Trials Helpdesk   
Address:  AbbVie House, Vanwall Business Park, Vanwall Road SL6 4UB Maidenhead, Berkshire United Kingdom
Telephone: 441628561090
Email: eu-clinical-trials@abbvie.com
Affiliation:  AbbVie Ltd
Name: EU Clinical Trials Helpdesk   
Address:  AbbVie House, Vanwall Business Park, Vanwall Road SL6 4UB Maidenhead, Berkshire United Kingdom
Telephone: 441628561090
Email: eu-clinical-trials@abbvie.com
Affiliation:  AbbVie Ltd
Key inclusion & exclusion criteria
Inclusion criteria:
1. Adult male or female, at least 18 years old.
2. Diagnosis of RA for = 3 months.
3. Subjects have been treated for = 3 months with = 1 bDMARD therapy, but continue to exhibit active RA or had to discontinue due to intolerability or toxicity, irrespective of treatment duration and have never received abatacept prior to the first dose of study drug.
4. 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. A combination of up to two background csDMARDs is allowed except the combination of MTX and leflunomide.
5. Meets the following criteria: = 6 swollen joints (based on 66 joint counts) and = 6 tender joints (based on 68 joint counts) at Screening and Baseline Visits and hsCRP = 3 mg/L 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 413
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 137

Exclusion criteria:
1. Prior exposure to any Janus kinase (JAK) inhibitor (including but not limited to tofacitinib, baricitinib, and filgotinib).
2. Prior exposure to abatacept
3. 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: 21.0 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: Upadacitinib
Product Code: ABT-494
Pharmaceutical Form: Tablet
INN or Proposed INN: Upadacitinib
CAS Number: 1310726-60-3
Other descriptive name: 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: ORENCIA 250mg powder for concentrate for solution for infusion
Product Name: Abatacept
Pharmaceutical Form: Powder for concentrate for solution for infusion
INN or Proposed INN: ABATACEPT
CAS Number: 332348-12-6
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 250-
Pharmaceutical form of the placebo: Solution for infusion
Route of administration of the placebo: Intravenous use

Primary Outcome(s)
Main Objective: 1. To compare the safety and efficacy of upadacitinib 15 mg once daily (QD) versus abatacept intravenous (IV) for the treatment of signs and symptoms of rheumatoid arthritis (RA) in bDMARD-inadequate response (bDMARD-IR) or bDMARD-intolerant subjects with moderately to severely active RA.
2. To evaluate the long-term safety, tolerability, and efficacy of upadacitinib 15 mg QD in subjects with RA.
Primary end point(s): Change from baseline in DAS28 (CRP) (non-inferiority).
Secondary Objective: 1. Change from baseline in DAS28 (CRP) at Week 12 (superiority);
2. Proportion of subjects achieving Clinical Remission (CR) at Week 12 (superiority)
Timepoint(s) of evaluation of this end point: Week 12
Secondary Outcome(s)
Secondary end point(s): 1. Change from baseline in DAS28 (CRP) (superiority);
2. Proportion of subjects achieving Clinical Remission (CR) (superiority)
Timepoint(s) of evaluation of this end point: Week 12
Secondary ID(s)
2016-000933-37-HU
M15-925
Source(s) of Monetary Support
AbbVie Inc.
Secondary Sponsor(s)
Ethics review
Status: Approved
Approval date: 09/05/2018
Contact:
Results
Results available:
Date Posted:
Date Completed:
URL:
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