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A Phase 3 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 ) (SELECT-CHOICE)

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ClinicalTrials.gov Identifier: NCT03086343
Recruitment Status : Active, not recruiting
First Posted : March 22, 2017
Last Update Posted : March 22, 2019
Sponsor:
Information provided by (Responsible Party):
AbbVie

Brief Summary:
The comparison of safety and efficacy of upadacitinib versus abatacept in participants with rheumatoid arthritis on a stable background conventional synthetic Disease Modifying Anti-Rheumatic Drug (csDMARD) who have an inadequate response or intolerance to biologic DMARDs.

Condition or disease Intervention/treatment Phase
Rheumatoid Arthritis (RA) Drug: Upadacitinib matching placebo Drug: Abatacept matching placebo Drug: Upadacitinib Drug: Abatacept Phase 3

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 614 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Phase 3, Randomized, Active-Controlled, Double Blind Study Comparing Upadacitinib (ABT-494) 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)
Actual Study Start Date : May 9, 2017
Estimated Primary Completion Date : February 29, 2020
Estimated Study Completion Date : June 7, 2022

Resource links provided by the National Library of Medicine

Drug Information available for: Abatacept

Arm Intervention/treatment
Active Comparator: Abatacept followed by upadacitinib
Intravenous (IV) infusion of abatacept at Baseline, Week 2, Week 4, Week 8, Week 12, Week 16 and Week 20 followed by upadacitinib starting at week 24 up to 5 years.
Drug: Upadacitinib matching placebo
Oral tablet

Drug: Abatacept
IV infusion

Experimental: Upadacitinib
Once daily for 24 weeks during Period 1 and up to 5 years during Period 2.
Drug: Abatacept matching placebo
IV infusion

Drug: Upadacitinib
Oral Tablet
Other Name: ABT-494




Primary Outcome Measures :
  1. Change in Disease Activity Score (DAS) 28 C-Reactive Protein (CRP) (non-inferiority) [ Time Frame: At week 12 ]
    The Disease Activity Score (DAS)28 is a validated index of rheumatoid arthritis disease activity. Scores on the DAS28 range from 0 to 10.


Secondary Outcome Measures :
  1. Proportion of participants achieving Disease Activity Score (DAS) 28 based Clinical Remission (CR) [ Time Frame: At week 12 ]
    Proportion of participants achieving Clinical Remission (CR) as defined by a clinical response Disease Activity Score (DAS)28 C-Reactive Protein (CRP) less than 2.6. The DAS28 is a validated index of rheumatoid arthritis disease activity. Scores on the DAS28 range from 0 to 10. A DAS28 score greater than 5.1 indicates high disease activity, a DAS28 score less than or equal to 3.2 indicates low disease activity, and a DAS28 score less than 2.6 indicates CR.

  2. Change in Disease Activity Score (DAS) 28 C-Reactive Protein (CRP) (superiority) [ Time Frame: At week 12 ]
    The DAS28 is a validated index of rheumatoid arthritis disease activity. Scores on the DAS28 range from 0 to 10.



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Diagnosis of rheumatoid arthritis (RA) for >= 3 months.
  • Participants 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.
  • Participants 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: methotrexate (MTX), sulfasalazine, hydroxychloroquine, chloroquine, and leflunomide. A combination of up to two background csDMARDs is allowed except the combination of MTX and leflunomide.
  • 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 .

Exclusion Criteria:

  • Prior exposure to any Janus kinase (JAK) inhibitor (including but not limited to upadacitinib, tofacitinib, baricitinib and filgotinib).
  • Prior exposure to abatacept
  • History of any arthritis with onset prior to age 17 years or current diagnosis of inflammatory joint disease other than RA. Current diagnosis of secondary Sjogren's Syndrome is permitted
  • Laboratory values meeting the following criteria within the Screening period prior to the first dose of study drug: serum aspartate transaminase > 2 × upper limit of normal (ULN); serum alanine transaminase > 2 × ULN; estimated glomerular filtration rate by simplified 4-variable Modification of Diet in Renal Disease formula < 40 milli liter (mL)/minute/1.73 meter (m)^2; total white blood cell count < 2,500/micro liter (μL); absolute neutrophil count < 1,500/μL; platelet count < 100,000/μL; absolute lymphocyte count < 800/μL; and hemoglobin < 10 g/ deciliter (dL).

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03086343


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Sponsors and Collaborators
AbbVie
Investigators
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Study Director: AbbVie Inc. AbbVie

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Responsible Party: AbbVie
ClinicalTrials.gov Identifier: NCT03086343     History of Changes
Other Study ID Numbers: M15-925
2016-000933-37 ( EudraCT Number )
First Posted: March 22, 2017    Key Record Dates
Last Update Posted: March 22, 2019
Last Verified: March 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: AbbVie is committed to responsible data sharing regarding the clinical trials we sponsor. This includes access to anonymized, individual and trial-level data (analysis data sets), as well as other information (e.g., protocols and clinical study reports), as long as the trials are not part of an ongoing or planned regulatory submission. This includes requests for clinical trial data for unlicensed products and indications.
Supporting Materials: Study Protocol
Statistical Analysis Plan (SAP)
Clinical Study Report (CSR)
Analytic Code
Time Frame: Data requests can be submitted at any time and the data will be accessible for 12 months, with possible extensions considered.
Access Criteria: Access to this clinical trial data can be requested by any qualified researchers who engage in rigorous, independent scientific research, and will be provided following review and approval of a research proposal and Statistical Analysis Plan (SAP) and execution of a Data Sharing Agreement (DSA). For more information on the process, or to submit a request, visit the following link.
URL: https://www.abbvie.com/our-science/clinical-trials/clinical-trials-data-and-information-sharing/data-and-information-sharing-with-qualified-researchers.html

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No

Keywords provided by AbbVie:
Musculoskeletal Disease
Arthritis
Joint Disease
Anti-inflammatory agents
Antirheumatic agents

Additional relevant MeSH terms:
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Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases
Connective Tissue Diseases
Autoimmune Diseases
Immune System Diseases
Arthritis
Arthritis, Rheumatoid
Abatacept
Upadacitinib
Antirheumatic Agents
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Janus Kinase Inhibitors
Protein Kinase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action