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A Study to Compare ABT-494 Monotherapy to Methotrexate Monotherapy in Subjects With Rheumatoid Arthritis (RA) Who Have Not Previously Taken Methotrexate (SELECT-EARLY)

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ClinicalTrials.gov Identifier: NCT02706873
Recruitment Status : Active, not recruiting
First Posted : March 11, 2016
Last Update Posted : March 12, 2019
Sponsor:
Information provided by (Responsible Party):
AbbVie

Brief Summary:
This is a randomized, double-blind study comparing ABT-494 monotherapy to Methotrexate (MTX) monotherapy in MTX-naïve subjects with moderately to severely active rheumatoid arthritis

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

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 1002 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) Once Daily Monotherapy to Methotrexate (MTX) Monotherapy in MTX-Naïve Subjects With Moderately to Severely Active Rheumatoid Arthritis
Actual Study Start Date : February 23, 2016
Actual Primary Completion Date : March 15, 2018
Estimated Study Completion Date : June 4, 2022

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: ABT-494 Dose B
ABT-494 Dose B once daily monotherapy and Methotrexate matching placebo orally once weekly.
Drug: Methotrexate matching placebo
Oral capsule

Drug: ABT-494
Oral Tablet
Other Name: Upadacitinib

Active Comparator: Methotrexate
Methotrexate orally once weekly and ABT-494 matching placebo orally once daily.
Drug: ABT-494 matching placebo
Oral tablet

Drug: Methotrexate
Oral capsule

Experimental: ABT-494 Dose A
ABT-494 Dose A once daily monotherapy and Methotrexate matching placebo orally once weekly.
Drug: Methotrexate matching placebo
Oral capsule

Drug: ABT-494
Oral Tablet
Other Name: Upadacitinib




Primary Outcome Measures :
  1. Proportion of participants achieving American College Rheumatology (ACR) 50 response [ 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.

  2. Proportion of subjects achieving Clinical remission (CR) based on Disease Activity 28 (DAS28) C-Reactive Protein (CRP) [ Time Frame: At Week 24 ]
    CR based on DAS28 (CRP) response rate is defined as DAS28 (CRP) less than 2.6


Secondary Outcome Measures :
  1. Change in Health Assessment Questionnaire Disability Index (HAQ-DI) [ Time Frame: From day 1 to week 12 ]
    HAQ-DI is a participant questionnaire with questions regarding the participant's illness and how it affect their daily life activities.

  2. ACR70 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.

  3. Change in Short Form-36 (SF-36) Physical Component Score (PCS) [ Time Frame: From day 1 to week 12 ]
    SF-36 is a 36 item participant questionnaire with questions regarding participant health and daily activities.

  4. Proportion of subjects achieving Low Disease Activity (LDA) [ Time Frame: Week 12 ]
    Low Disease Activity (LDA)is defined as Disease Activity Score (DAS)28 (CRP) <= 3.2

  5. Change in modified Total Sharp Score (mTSS) [ Time Frame: From day 1 to week 24 ]
    For mTSS, x-rays of hand/wrist, feet joints and joint spaces are scored for erosions and joint space narrowing, which will be summed to determine the total score, which ranges from 0 (no damage) to 448.

  6. ACR20 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.

  7. Proportion of subjects with no radiographic progression [ Time Frame: Week 24 ]
    It is defined as change in mTSS <= 0

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



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:

  • Duration of symptoms consistent with RA for ≥ 6 weeks who also fulfill the 2010 ACR/EULAR classification criteria for RA.
  • Naïve to Methotrexate (MTX) or, if already on MTX, have received no more than 3 weekly MTX doses with requirement to complete a 4-week MTX washout before the first dose of study drug.
  • Subjects with prior exposure to conventional synthetic disease-modifying anti-rheumatic drugs(csDMARDs) other than MTX may be enrolled if completed the washout period.
  • Subject meets the following minimum disease activity criteria: greater than or equal to 6 swollen joints (based on 66 joint counts) and greater than or equal to 6 tender joints (based on 68 joint counts) at Screening and Baseline Visits.
  • Greater than or equal to 1 bone erosion on x-ray (by local reading) OR in the absence of documented bone erosion, both positive rheumatoid factor and positive anti-cyclic citrullinated peptide autoantibodies are required at Screening.

Exclusion Criteria:

  • Intolerant to Methotrexate (MTX).
  • Prior exposure to any Janus kinase (JAK) inhibitor (including but not limited to tofacitinib, baricitinib, and filgotinib).
  • Prior exposure to any biologic disease-modifying anti-rheumatic drugs (bDMARDs).
  • History of any arthritis with onset prior to age 17 years or current diagnosis, inflammatory joint disease other than RA (including but not limited to gout, systemic lupus erythematosus, psoriatic arthritis, axial spondyloarthritis including ankylosing spondylitis and non-radiographic axial SpA, reactive arthritis, overlap connective tissue diseases, scleroderma, polymyositis, dermatomyositis, fibromyalgia [currently with active symptoms]. 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): NCT02706873


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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: NCT02706873     History of Changes
Other Study ID Numbers: M13-545
2015-003334-27 ( EudraCT Number )
First Posted: March 11, 2016    Key Record Dates
Last Update Posted: March 12, 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