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A Study to Compare Upadacitinib (ABT-494) to Placebo 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-BEYOND)

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ClinicalTrials.gov Identifier: NCT02706847
Recruitment Status : Active, not recruiting
First Posted : March 11, 2016
Last Update Posted : February 18, 2019
Sponsor:
Information provided by (Responsible Party):
AbbVie

Brief Summary:
The comparison of safety and efficacy of two doses of Upadacitinib (ABT-494) versus placebo in participants with rheumatoid arthritis on a stable background conventional synthetic Disease Modifying Anti-Rheumatic Drug (csDMARD).

Condition or disease Intervention/treatment Phase
Rheumatoid Arthritis Drug: ABT-494 Drug: Placebo Phase 3

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 499 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Phase 3, Randomized, Double-Blind Study Comparing Upadacitinib (ABT-494) to Placebo on Stable Conventional Synthetic Disease-Modifying Anti-Rheumatic Drugs (csDMARDs) in Subjects With Moderately to Severely Active Rheumatoid Arthritis With Inadequate Response or Intolerance to Biologic DMARDs (bDMARDs)
Actual Study Start Date : March 15, 2016
Actual Primary Completion Date : April 3, 2017
Estimated Study Completion Date : September 16, 2021

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: ABT-494 Dose A
ABT-494 Dose A once daily for 240 weeks
Drug: ABT-494
ABT-494 oral tablet
Other Name: Upadacitinib

Experimental: ABT-494 Dose B
ABT-494 Dose B once daily for 240 weeks
Drug: ABT-494
ABT-494 oral tablet
Other Name: Upadacitinib

Placebo Comparator: Placebo followed by ABT-494 Dose B
Placebo once daily for 12 weeks followed by ABT-494 Dose B for 228 weeks
Drug: ABT-494
ABT-494 oral tablet
Other Name: Upadacitinib

Drug: Placebo
Oral tablet

Placebo Comparator: Placebo followed by ABT-494 Dose A
Placebo once daily for 12 weeks followed by ABT-494 Dose A for 228 weeks
Drug: ABT-494
ABT-494 oral tablet
Other Name: Upadacitinib

Drug: Placebo
Oral tablet




Primary Outcome Measures :
  1. Proportion of participants achieving American College Rheumatology (ACR) 20 response rate [ Time Frame: At week 12 ]
    ACR criteria measure improvements in tender and swollen joint counts, patient assessments of pain, global disease activity and physical function, physician global assessment of disease activity and acute phase reactant.


Secondary Outcome Measures :
  1. Proportion of participants achieving low disease activity (LDA) [ Time Frame: At week 12 ]
    Proportion of participants achieving low disease activity as defined by a clinical response DAS28[CRP] less than or equal to 3.2. 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 clinical remission.

  2. Change in Short-Form 36 (SF-36) Physical Component Score (PCS) [ Time Frame: At week 12 ]
    SF-36 is a 36 item participant questionnaire with questions regarding participant health and daily activities.

  3. Change in Health Assessment Questionnaire Disability Index (HAQ-DI) [ Time Frame: At week 12 ]
    HAQ-DI is a participant questionnaire with questions regarding the participant's illness and how it affect their daily life activities.

  4. Change in Disease Activity Score (DAS)28 C-Reactive Protein (CRP) [ 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 to 99 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Diagnosis of rheumatoid arthritis (RA) for >= 3 months.
  • 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 prior to the first dose of study drug.
  • 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: 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.

Exclusion Criteria:

  • Prior exposure to any Janus kinase (JAK) inhibitor (including but not limited to tofacitinib, baricitinib, and filgotinib).
  • Current diagnosis of inflammatory joint disease other than RA. Current diagnosis of secondary Sjogren's Syndrome is permitted.

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): NCT02706847


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

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: AbbVie
ClinicalTrials.gov Identifier: NCT02706847     History of Changes
Other Study ID Numbers: M13-542
2015-003335-35 ( EudraCT Number )
First Posted: March 11, 2016    Key Record Dates
Last Update Posted: February 18, 2019
Last Verified: February 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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Arthritis
Arthritis, Rheumatoid
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases
Connective Tissue Diseases
Autoimmune Diseases
Immune System Diseases
Upadacitinib
Antirheumatic Agents
Janus Kinase Inhibitors
Protein Kinase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action