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A Study Comparing Upadacitinib (ABT-494) to Placebo in Subjects With Rheumatoid Arthritis on a Stable Dose of Conventional Synthetic Disease-Modifying Antirheumatic Drugs (csDMARDs) Who Have an Inadequate Response to csDMARDs Alone (SELECT-NEXT)

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ClinicalTrials.gov Identifier: NCT02675426
Recruitment Status : Active, not recruiting
First Posted : February 5, 2016
Last Update Posted : April 25, 2018
Sponsor:
Information provided by (Responsible Party):
AbbVie

Brief Summary:
This is a multi center, randomized, double-blind, placebo-controlled phase 3 study in subjects with moderately to severely active rheumatoid arthritis on a stable dose of csDMARDs who have had an inadequate response to csDMARDs.

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

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 662 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 in Subjects With Moderately to Severely Active Rheumatoid Arthritis Who Are on a Stable Dose of Conventional Synthetic Disease-Modifying Anti-Rheumatic Drugs (csDMARDs) and Have an Inadequate Response to csDMARDs
Actual Study Start Date : December 17, 2015
Actual Primary Completion Date : April 21, 2017
Estimated Study Completion Date : August 6, 2020

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Placebo Comparator: Placebo followed by ABT-494 Dose A
Placebo once daily for 12 weeks (Period 1) followed by ABT-494 Dose A once daily for up to 5 years (Period 2)
Drug: Placebo
Oral tablet

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 (Period 1) followed by ABT-494 Dose B once daily for up to 5 years (Period 2)
Drug: Placebo
Oral tablet

Drug: ABT-494
ABT-494 oral tablet
Other Name: Upadacitinib

Experimental: ABT-494 Dose A
ABT-494 Dose A once daily for 12 weeks (Period 1) and up to an additional 5 years (Period 2)
Drug: ABT-494
ABT-494 oral tablet
Other Name: Upadacitinib

Experimental: ABT-494 Dose B
ABT-494 Dose B once daily for 12 weeks (Period 1) and up to an additional 5 years (Period 2)
Drug: ABT-494
ABT-494 oral tablet
Other Name: Upadacitinib




Primary Outcome Measures :
  1. Proportion of Participants achieving American College of Rheumatology (ACR) 20 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 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.


Secondary Outcome Measures :
  1. Change in Functional Assessment of Chronic Illness Therapy (FACIT-F) [ Time Frame: From Day 1 to Week 12 ]
    FACIT-F is participant questionnaire with 13 indexes rated on a 5 point scale. The indexes generally relate to the participant's level of fatigue during the past 7 days.

  2. Low Disease Activity (LDA) based on Disease Activity Score (DAS28) C-Reactive Protein (CRP) [ Time Frame: At Week 12 ]
    LDA is defined as DAS28 CRP less than or equal to 3.2

  3. Low Disease Activity (LDA) based on Clinical Disease Activity Index (CDAI) [ Time Frame: At Week 12 ]
    LDA based on CDAI is defined as CDAI less than or equal to 10. CDAI is a calculation using tender and swollen joint counts and patient and physician assessments of pain and disease.

  4. Change in Morning Stiffness severity [ Time Frame: From Day 1 to Week 12 ]
    Morning Stiffness severity is determined by the Patient's Assessment of Severity and Duration of Morning Stiffness questionnaire. The severity score is based on a single 0 to 10 rating scale with 0 indicating "No morning stiffness" and 10 indicating "Worst possible morning stiffness"

  5. 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.

  6. Change in Short-Form 36 (SF-36) [ Time Frame: From Day 1 to Week 12 ]
    SF-36 is a 36 item participant questionnaire with questions regarding participant health and daily activities.

  7. 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.

  8. Clinical remission (CR) based on Disease Activity 28 (DAS28) C-Reactive Protein (CRP) [ Time Frame: At Week 12 ]
    CR based on DAS28 (CRP) response rate is defined as DAS28 (CRP) less than 2.6



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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:

  • Adult male or female, at least 18 years old.
  • Diagnosis of Rheumatoid Arthritis (RA) for greater than or equal to 3 months.
  • Subjects have been receiving conventional synthetic DMARD (csDMARD) therapy for greater than or equal to 3 months and on a stable dose for greater than or equal to 4 weeks prior to the first dose of study drug. The following csDMARDs are allowed: Methotrexate (MTX), sulfasalazine, hydroxychloroquine, chloroquine, and leflunomide.
  • 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.
  • Subjects with prior exposure to at most one biologic DMARD (bDMARD) may be enrolled (up to 20% of study population) if they have documented evidence of intolerance to bDMARDs or limited exposure (less than 3 months) and have satisfied required washout periods.

Exclusion Criteria:

  • Prior exposure to any Janus kinase (JAK) inhibitor (including but not limited to tofacitinib, baricitinib, and filgotinib).
  • History of inflammatory joint disease other than RA. History of secondary Sjogren's Syndrome is permitted.
  • Subjects who are considered inadequate responders to bDMARD therapy as determined by the Investigator.

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): NCT02675426


  Show 165 Study Locations
Sponsors and Collaborators
AbbVie
Investigators
Study Director: AbbVie Inc. AbbVie

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: AbbVie
ClinicalTrials.gov Identifier: NCT02675426     History of Changes
Other Study ID Numbers: M13-549
2015-003332-13 ( EudraCT Number )
First Posted: February 5, 2016    Key Record Dates
Last Update Posted: April 25, 2018
Last Verified: April 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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:
Arthritis
Arthritis, Rheumatoid
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases
Connective Tissue Diseases
Autoimmune Diseases
Immune System Diseases
Antirheumatic Agents