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A Study Comparing Upadacitinib (ABT-494) Monotherapy to Methotrexate (MTX) Monotherapy in Subjects With Rheumatoid Arthritis (RA) Who Have an Inadequate Response to MTX (SELECT-MONOTHERAPY)

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ClinicalTrials.gov Identifier: NCT02706951
Recruitment Status : Active, not recruiting
First Posted : March 11, 2016
Last Update Posted : March 6, 2019
Sponsor:
Information provided by (Responsible Party):
AbbVie

Brief Summary:
This is a randomized, double-blind study comparing Upadacitinib (ABT-494) monotherapy to Methotrexate (MTX) monotherapy in subjects with moderately to severely active rheumatoid arthritis who have had an inadequate response to methotrexate treatment.

Condition or disease Intervention/treatment Phase
Rheumatoid Arthritis Drug: Methotrexate Drug: ABT-494 Drug: ABT-494 matching placebo Drug: Methotrexate matching placebo Phase 3

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 648 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) Monotherapy to Methotrexate (MTX) in Subjects With Moderately to Severely Active Rheumatoid Arthritis With Inadequate Response to MTX
Actual Study Start Date : March 2, 2016
Actual Primary Completion Date : October 2, 2017
Estimated Study Completion Date : February 27, 2022

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
Oral tablet
Other Name: Upadacitinib

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

Active Comparator: Methotrexate followed by ABT-494 Dose B
Methotrexate for 14 weeks followed by ABT-494 Dose B for 226 weeks
Drug: Methotrexate
Oral capsule

Drug: ABT-494 matching placebo
Oral tablet

Drug: Methotrexate matching placebo
Oral capsule

Active Comparator: Methotrexate followed by ABT-494 Dose A
Methotrexate for 14 weeks followed by ABT-494 Dose A for 226 weeks
Drug: Methotrexate
Oral capsule

Drug: ABT-494 matching placebo
Oral tablet

Drug: Methotrexate matching placebo
Oral capsule




Primary Outcome Measures :
  1. Proportion of participants achieving American College of Rheumatologist (ACR) 20 response [ Time Frame: At week 14 ]
    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. Low Disease Activity (LDA) based on Disease Activity Score (DAS) 28 (CRP) [ Time Frame: At week 14 ]
    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 from baseline in morning stiffness (duration) [ Time Frame: From week 0 to week 14 ]
    The Patient's Assessment of Severity and Duration of Morning Stiffness Numerical Rating Scale (NRS) is a participant assessment to record the participant's experience with morning stiffness.

  3. Change in Heath Assessment Questionnaire and Disability Index (HAQ-DI) [ Time Frame: From week 0 to week 14 ]
    HAQ-DI is a participant questionnaire with questions regarding the participant's illness and how it affects their daily life activities.

  4. Change in DAS 28 (CRP) [ Time Frame: From week 0 to week 14 ]
    The DAS28 is a validated index of rheumatoid arthritis disease activity. Scores on the DAS28 range from 0 to 10.

  5. Proportion of participants achieving Clinical remission (CR) (DAS28 [CRP] < 2.6) [ Time Frame: At week 14 ]
    CR based on DAS28 (CRP) response rate is defined as DAS28 (CRP) less than 2.6

  6. Change in Short Form-36 (SF-36) Physical Component Score (PCS) [ Time Frame: From week 0 to week 14 ]
    SF-36 is a 36 item participant questionnaire with questions regarding participant health and daily activities.



Information from the National Library of Medicine

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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 RA for >= 3 months.
  • Subjects must have been on oral or parenteral MTX therapy >= 3 months and on a stable dose for >= 4 weeks prior to first dose of study drug.
  • Must have discontinued all conventional synthetic disease-modifying anti-rheumatic drugs (csDMARDs) (other than MTX) >= 4 weeks prior to first dose of study drug.
  • Meets the following 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.

Exclusion Criteria:

  • Prior exposure to any Janus kinase (JAK) inhibitor (including but not limited to tofacitinib, baricitinib, and filgotinib).
  • Prior exposure to any biological disease-modifying anti-rheumatic drugs (bDMARDs).
  • 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): NCT02706951


  Show 153 Study Locations
Sponsors and Collaborators
AbbVie
Investigators
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Study Director: AbbVie Inc. AbbVie

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Responsible Party: AbbVie
ClinicalTrials.gov Identifier: NCT02706951     History of Changes
Other Study ID Numbers: M15-555
2015-003376-75 ( EudraCT Number )
First Posted: March 11, 2016    Key Record Dates
Last Update Posted: March 6, 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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Arthritis
Arthritis, Rheumatoid
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases
Connective Tissue Diseases
Autoimmune Diseases
Immune System Diseases
Methotrexate
Upadacitinib
Abortifacient Agents, Nonsteroidal
Abortifacient Agents
Reproductive Control Agents
Physiological Effects of Drugs
Antimetabolites, Antineoplastic
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Dermatologic Agents
Enzyme Inhibitors
Folic Acid Antagonists
Immunosuppressive Agents
Immunologic Factors
Antirheumatic Agents
Nucleic Acid Synthesis Inhibitors
Janus Kinase Inhibitors
Protein Kinase Inhibitors