A Study Evaluating the Safety and Efficacy of Upadacitinib in Subjects With Active Ankylosing Spondylitis

Description

This is a Phase 2/3 multicenter, randomized, double-blind, placebo-controlled study to evaluate the safety and efficacy of upadacitinib in participants with active ankylosing spondylitis (AS).

Study Start Date

October, 24 2017

Estimated Completion Date

October 2020

Interventions

  • Drug: Upadacitinib
  • Drug: Upadacitinib Placebo

Study ID

AbbVie -- M16-098

Status

Recruiting

Trial ID

NCT03178487

Study Type

Interventional

Trial Phase

Phase 2

Enrollment Quota

170

Sponsor

AbbVie

Inclusion Criteria

  • Participant with a clinical diagnosis of Ankylosing Spondylitis (AS) and meeting the modified New York Criteria for AS.
  • Participant must have baseline disease activity as defined by having a Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) score >= 4 and a Patient's Assessment of Total Back Pain score >= 4 based on a 0
  • 10 Numeric Rating Scale (NRS) at the Screening and Baseline Visits.
  • Participant has had an inadequate response to at least two Nonsteroidal Anti-inflammatory Drugs (NSAIDs) over an at least 4-week period in total at maximum recommended or tolerated doses, or participant has an intolerance to or contraindication for NSAIDs as defined by the Investigator.
  • If entering the study on concomitant Methotrexate (MTX), leflunomide, Sulfasalazine (SSZ), and/or hydroxychloroquine, participant must be on a stable dose of MTX (<= 25 mg/week) and/or SSZ (<= 3 g/day) and/or hydroxychloroquine (<= 400 mg/day) or leflunomide (<= 20 mg/day) for at least 28 days prior to the Baseline Visit. A combination of up to two background conventional synthetic disease-modifying anti-rheumatic drugs (csDMARDs) is allowed except the combination of MTX and leflunomide.
  • If entering the study on concomitant oral corticosteroids, participant must be on a stable dose of prednisone (<= 10 mg/day), or oral corticosteroid equivalents, for at least 14 days prior to the Baseline Visit.
  • If entering the study on concomitant NSAIDs, tramadol, combination of acetaminophen and codeine or hydrocodone, and/or non-opioid analgesics, participant must be on stable dose(s) for at least 14 days prior to the Baseline Visit.

Exclusion Criteria

  • Prior exposure to any Janus kinase (JAK) inhibitor (including but not limited to tofacitinib, baricitinib, and filgotinib).
  • Prior exposure to any biologic therapy with a potential therapeutic impact on spondyloarthritis (SpA).
  • Intra-articular joint injections, spinal/paraspinal injection(s), or parenteral administration of corticosteroids within 28 days prior to the Baseline Visit. Inhaled or topical corticosteroids are allowed.
  • Participant on any other DMARDs (other than those allowed), thalidomide or apremilast within 28 days or five half-lives (whichever is longer) of the drug prior to the Baseline Visit.
  • Participant on opioid analgesics (except for combination acetaminophen/codeine or acetaminophen/hydrocodone which are allowed) or use of inhaled marijuana within 14 days prior to the Baseline Visit.
  • Participant has a history of inflammatory arthritis of different etiology other than axial SpA (including but not limited to rheumatoid arthritis, psoriatic arthritis, mixed connective tissue disease, systemic lupus erythematosus, reactive arthritis, scleroderma, polymyositis, dermatomyositis, fibromyalgia, or any arthritis with onset prior to 17 years of age.
  • 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 milliliter (mL)/minute/1.73m^2 hemoglobin < 10 gram/deciliter, total white blood cell count < 2,500/microliter (?L) absolute neutrophil count < 1,500/?L absolute lymphocyte count < 800/?L and platelet count < 100,000/?L.

Gender

All

Ages

18 Years to 99 Years

Accepts Healthy Volunteers

No

Study Locations and Contact Information (132)

Study Location Distance Name Phone Email
Massachusetts General Hospital ID 167772 - Boston, Massachusetts 2.8 miles None None None
Massachusetts General Hospital ID 167772 - Boston, Massachusetts 2.8 miles None None None
Massachusetts General Hospital ID 167772 - Boston, Massachusetts 2.8 miles None None None
Massachusetts General Hospital ID 167772 - Boston, Massachusetts 2.8 miles None None None
Massachusetts General Hospital ID 167772 - Boston, Massachusetts 2.8 miles None None None
Massachusetts General Hospital ID 167772 - Boston, Massachusetts 2.8 miles None None None
St Lawrence Health System Medical Campus ID 165025 - Canton, New York 254.6 miles None None None
St Lawrence Health System Medical Campus ID 165025 - Canton, New York 254.6 miles None None None
St Lawrence Health System Medical Campus ID 165025 - Canton, New York 254.6 miles None None None
St Lawrence Health System Medical Campus ID 165025 - Canton, New York 254.6 miles None None None
St Lawrence Health System Medical Campus ID 165025 - Canton, New York 254.6 miles None None None
St Lawrence Health System Medical Campus ID 165025 - Canton, New York 254.6 miles None None None
Clinical Research Center of Reading LLP ID 164876 - Wyomissing, Pennsylvania 289.8 miles None None None
Clinical Research Center of Reading LLP ID 164876 - Wyomissing, Pennsylvania 289.8 miles None None None
Clinical Research Center of Reading LLP ID 164876 - Wyomissing, Pennsylvania 289.8 miles None None None
Clinical Research Center of Reading LLP ID 164876 - Wyomissing, Pennsylvania 289.8 miles None None None
Clinical Research Center of Reading LLP ID 164876 - Wyomissing, Pennsylvania 289.8 miles None None None
Clinical Research Center of Reading LLP ID 164876 - Wyomissing, Pennsylvania 289.8 miles None None None
Altoona Center for Clinical Research ID 164470 - Duncansville, Pennsylvania 403.7 miles None None None
Altoona Center for Clinical Research ID 164470 - Duncansville, Pennsylvania 403.7 miles None None None
Altoona Center for Clinical Research ID 164470 - Duncansville, Pennsylvania 403.7 miles None None None
Altoona Center for Clinical Research ID 164470 - Duncansville, Pennsylvania 403.7 miles None None None
Altoona Center for Clinical Research ID 164470 - Duncansville, Pennsylvania 403.7 miles None None None
Altoona Center for Clinical Research ID 164470 - Duncansville, Pennsylvania 403.7 miles None None None
Henry Ford Health System ID 165515 - Detroit, Michigan 612.3 miles None None None
Henry Ford Health System ID 165515 - Detroit, Michigan 612.3 miles None None None
Henry Ford Health System ID 165515 - Detroit, Michigan 612.3 miles None None None
Henry Ford Health System ID 165515 - Detroit, Michigan 612.3 miles None None None
Henry Ford Health System ID 165515 - Detroit, Michigan 612.3 miles None None None
Henry Ford Health System ID 165515 - Detroit, Michigan 612.3 miles None None None
Aa Mrc Llc Id 165100 - Grand Blanc, Michigan 639.2 miles None None None
Aa Mrc Llc Id 165100 - Grand Blanc, Michigan 639.2 miles None None None
Aa Mrc Llc Id 165100 - Grand Blanc, Michigan 639.2 miles None None None
Aa Mrc Llc Id 165100 - Grand Blanc, Michigan 639.2 miles None None None
Aa Mrc Llc Id 165100 - Grand Blanc, Michigan 639.2 miles None None None
Aa Mrc Llc Id 165100 - Grand Blanc, Michigan 639.2 miles None None None
DJL Clinical Research PLLC ID 165044 - Charlotte, North Carolina 726.2 miles None None None
DJL Clinical Research PLLC ID 165044 - Charlotte, North Carolina 726.2 miles None None None
DJL Clinical Research PLLC ID 165044 - Charlotte, North Carolina 726.2 miles None None None
DJL Clinical Research PLLC ID 165044 - Charlotte, North Carolina 726.2 miles None None None
DJL Clinical Research PLLC ID 165044 - Charlotte, North Carolina 726.2 miles None None None
DJL Clinical Research PLLC ID 165044 - Charlotte, North Carolina 726.2 miles None None None
West Michigan Rheumatology PLLC ID 164808 - Grand Rapids, Michigan 735.6 miles None None None
West Michigan Rheumatology PLLC ID 164808 - Grand Rapids, Michigan 735.6 miles None None None
West Michigan Rheumatology PLLC ID 164808 - Grand Rapids, Michigan 735.6 miles None None None
West Michigan Rheumatology PLLC ID 164808 - Grand Rapids, Michigan 735.6 miles None None None
West Michigan Rheumatology PLLC ID 164808 - Grand Rapids, Michigan 735.6 miles None None None
West Michigan Rheumatology PLLC ID 164808 - Grand Rapids, Michigan 735.6 miles None None None
Clinical Investigation Specialists Inc ID 164385 - Skokie, Illinois 852.2 miles None None None
Clinical Investigation Specialists Inc ID 164385 - Skokie, Illinois 852.2 miles None None None
Clinical Investigation Specialists Inc ID 164385 - Skokie, Illinois 852.2 miles None None None
Clinical Investigation Specialists Inc ID 164385 - Skokie, Illinois 852.2 miles None None None
Clinical Investigation Specialists Inc ID 164385 - Skokie, Illinois 852.2 miles None None None
Clinical Investigation Specialists Inc ID 164385 - Skokie, Illinois 852.2 miles None None None
Comprehensive Rheumatology Care ID 168107 - Hendersonville, Tennessee 928.5 miles None None None
Comprehensive Rheumatology Care ID 168107 - Hendersonville, Tennessee 928.5 miles None None None
Comprehensive Rheumatology Care ID 168107 - Hendersonville, Tennessee 928.5 miles None None None
Comprehensive Rheumatology Care ID 168107 - Hendersonville, Tennessee 928.5 miles None None None
Comprehensive Rheumatology Care ID 168107 - Hendersonville, Tennessee 928.5 miles None None None
Comprehensive Rheumatology Care ID 168107 - Hendersonville, Tennessee 928.5 miles None None None
Little Rock Diagnostics Clinic ID 164386 - Little Rock, Arkansas 1,261.1 miles None None None
Little Rock Diagnostics Clinic ID 164386 - Little Rock, Arkansas 1,261.1 miles None None None
Little Rock Diagnostics Clinic ID 164386 - Little Rock, Arkansas 1,261.1 miles None None None
Little Rock Diagnostics Clinic ID 164386 - Little Rock, Arkansas 1,261.1 miles None None None
Little Rock Diagnostics Clinic ID 164386 - Little Rock, Arkansas 1,261.1 miles None None None
Little Rock Diagnostics Clinic ID 164386 - Little Rock, Arkansas 1,261.1 miles None None None
LeJenue Research Associates PLLC ID 165202 - Miami, Florida 1,262.4 miles None None None
LeJenue Research Associates PLLC ID 165202 - Miami, Florida 1,262.4 miles None None None
LeJenue Research Associates PLLC ID 165202 - Miami, Florida 1,262.4 miles None None None
LeJenue Research Associates PLLC ID 165202 - Miami, Florida 1,262.4 miles None None None
LeJenue Research Associates PLLC ID 165202 - Miami, Florida 1,262.4 miles None None None
LeJenue Research Associates PLLC ID 165202 - Miami, Florida 1,262.4 miles None None None
Diagnostic Group Integrated Health Systems PLLC ID 165195 - Beaumont, Texas 1,533.9 miles None None None
Diagnostic Group Integrated Health Systems PLLC ID 165195 - Beaumont, Texas 1,533.9 miles None None None
Diagnostic Group Integrated Health Systems PLLC ID 165195 - Beaumont, Texas 1,533.9 miles None None None
Diagnostic Group Integrated Health Systems PLLC ID 165195 - Beaumont, Texas 1,533.9 miles None None None
Diagnostic Group Integrated Health Systems PLLC ID 165195 - Beaumont, Texas 1,533.9 miles None None None
Diagnostic Group Integrated Health Systems PLLC ID 165195 - Beaumont, Texas 1,533.9 miles None None None
Dallas VA Medical Center ID 165513 - Dallas, Texas 1,553.3 miles None None None
Dallas VA Medical Center ID 165513 - Dallas, Texas 1,553.3 miles None None None
Dallas VA Medical Center ID 165513 - Dallas, Texas 1,553.3 miles None None None
Dallas VA Medical Center ID 165513 - Dallas, Texas 1,553.3 miles None None None
Dallas VA Medical Center ID 165513 - Dallas, Texas 1,553.3 miles None None None
Dallas VA Medical Center ID 165513 - Dallas, Texas 1,553.3 miles None None None
Colorado Arthritis Associates ID 164444 - Lakewood, Colorado 1,777.0 miles None None None
Colorado Arthritis Associates ID 164444 - Lakewood, Colorado 1,777.0 miles None None None
Colorado Arthritis Associates ID 164444 - Lakewood, Colorado 1,777.0 miles None None None
Colorado Arthritis Associates ID 164444 - Lakewood, Colorado 1,777.0 miles None None None
Colorado Arthritis Associates ID 164444 - Lakewood, Colorado 1,777.0 miles None None None
Colorado Arthritis Associates ID 164444 - Lakewood, Colorado 1,777.0 miles None None None
St Lukes Clinic ID 165827 - Meridian, Idaho 2,268.1 miles None None None
St Lukes Clinic ID 165827 - Meridian, Idaho 2,268.1 miles None None None
St Lukes Clinic ID 165827 - Meridian, Idaho 2,268.1 miles None None None
St Lukes Clinic ID 165827 - Meridian, Idaho 2,268.1 miles None None None
St Lukes Clinic ID 165827 - Meridian, Idaho 2,268.1 miles None None None
St Lukes Clinic ID 165827 - Meridian, Idaho 2,268.1 miles None None None
Oregon Health Science University OHSU ID 165074 - Portland, Oregon 2,538.3 miles None None None
Oregon Health Science University OHSU ID 165074 - Portland, Oregon 2,538.3 miles None None None
Oregon Health Science University OHSU ID 165074 - Portland, Oregon 2,538.3 miles None None None
Oregon Health Science University OHSU ID 165074 - Portland, Oregon 2,538.3 miles None None None
Oregon Health Science University OHSU ID 165074 - Portland, Oregon 2,538.3 miles None None None
Oregon Health Science University OHSU ID 165074 - Portland, Oregon 2,538.3 miles None None None
Valley Radiology Consultants ID 166167 - Escondido, California 2,566.6 miles None None None
Valley Radiology Consultants ID 166167 - Escondido, California 2,566.6 miles None None None
Valley Radiology Consultants ID 166167 - Escondido, California 2,566.6 miles None None None
Valley Radiology Consultants ID 166167 - Escondido, California 2,566.6 miles None None None
Valley Radiology Consultants ID 166167 - Escondido, California 2,566.6 miles None None None
Valley Radiology Consultants ID 166167 - Escondido, California 2,566.6 miles None None None
Kotha and Kotha ID 166165 - La Mesa, California 2,573.5 miles None None None
Kotha and Kotha ID 166165 - La Mesa, California 2,573.5 miles None None None
Kotha and Kotha ID 166165 - La Mesa, California 2,573.5 miles None None None
Kotha and Kotha ID 166165 - La Mesa, California 2,573.5 miles None None None
Kotha and Kotha ID 166165 - La Mesa, California 2,573.5 miles None None None
Kotha and Kotha ID 166165 - La Mesa, California 2,573.5 miles None None None
Medvin Clinical Research ID 165061 - Covina, California 2,576.6 miles None None None
Medvin Clinical Research ID 165061 - Covina, California 2,576.6 miles None None None
Medvin Clinical Research ID 165061 - Covina, California 2,576.6 miles None None None
Medvin Clinical Research ID 165061 - Covina, California 2,576.6 miles None None None
Medvin Clinical Research ID 165061 - Covina, California 2,576.6 miles None None None
Medvin Clinical Research ID 165061 - Covina, California 2,576.6 miles None None None
St Joseph Health System ID 166166 - Fullerton, California 2,582.9 miles None None None
St Joseph Health System ID 166166 - Fullerton, California 2,582.9 miles None None None
St Joseph Health System ID 166166 - Fullerton, California 2,582.9 miles None None None
St Joseph Health System ID 166166 - Fullerton, California 2,582.9 miles None None None
St Joseph Health System ID 166166 - Fullerton, California 2,582.9 miles None None None
St Joseph Health System ID 166166 - Fullerton, California 2,582.9 miles None None None
David S Hallegua MD A professional corporation ID 165090 - Beverly Hills, California 2,601.9 miles None None None
David S Hallegua MD A professional corporation ID 165090 - Beverly Hills, California 2,601.9 miles None None None
David S Hallegua MD A professional corporation ID 165090 - Beverly Hills, California 2,601.9 miles None None None
David S Hallegua MD A professional corporation ID 165090 - Beverly Hills, California 2,601.9 miles None None None
David S Hallegua MD A professional corporation ID 165090 - Beverly Hills, California 2,601.9 miles None None None
David S Hallegua MD A professional corporation ID 165090 - Beverly Hills, California 2,601.9 miles None None None

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