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

Ankylosing Spondylitis (AS) Clinical Trial

— SELECT-AXIS 1  

Official title:

A Multicenter, Randomized, Double-Blind, Placebo-Controlled Study Evaluating the Safety and Efficacy of Upadacitinib in Subjects With Active Ankylosing Spondylitis

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03178487
• Other study ID #: M16-098
• Secondary ID: 2017-000431-14
• Status: Completed
• Phase: Phase 2
• Start date: October 24, 2017
• Est. completion date: February 17, 2022

Study information

• Verified date: February 2023
• Source: AbbVie
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The purpose of this study is to evaluate the safety and efficacy of upadacitinib in participants with active ankylosing spondylitis (AS) who have had an inadequate response to at least 2 non-steroidal anti-inflammatory drugs (NSAIDs) or intolerance to or a contraindication for NSAIDs, and who are naïve to biologic disease-modifying anti-rheumatic drugs (bDMARD).

Description:

This study includes two periods: a 14-week double-blind placebo-controlled period and a 90-week open-label long-term extension period.

Eligible participants were randomly assigned in a 1:1 ratio to receive upadacitinib 15 mg or placebo for 14 weeks in Period 1.

Participants who completed Period 1 received upadacitinib 15 mg for 90 weeks in the extension period.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 187
• Est. completion date: February 17, 2022
• Est. primary completion date: January 21, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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 (µL); absolute neutrophil count < 1,500/µL; absolute lymphocyte count < 800/µL; and platelet count < 100,000/µL.

Related Conditions & MeSH terms

• Ankylosing Spondylitis (AS)
• Spondylarthritis
• Spondylitis
• Spondylitis, Ankylosing

Intervention

Drug:
• Upadacitinib
Tablet
• Placebo
Tablet

Locations

Country	Name	City	State
Australia	Emeritus Research /ID# 169240	Camberwell	Victoria
Australia	Princess Alexandra Hospital /ID# 169239	Woolloongabba	Queensland
Belgium	ReumaClinic Genk /ID# 166018	Genk
Belgium	UZ Gent /ID# 166017	Gent	Oost-Vlaanderen
Belgium	UZ Leuven /ID# 166019	Leuven
Canada	Rheumatology Research Assoc /ID# 165240	Edmonton	Alberta
Canada	University of Alberta - Division of Rheumatology /ID# 165239	Edmonton	Alberta
Canada	Credit Valley Rheumatology /ID# 200087	Mississauga	Ontario
Canada	Groupe de Recherche en Maladies Osseuses Inc /ID# 165238	Sainte-foy	Quebec
Croatia	Clinical Hospital Dubrava /ID# 167049	Zagreb
Croatia	Medical Center Kuna-Peric /ID# 164851	Zagreb
Czechia	REVMACLINIC s.r.o. /ID# 167171	Brno
Czechia	ARTHROHELP, s.r.o. /ID# 167001	Pardubice
Czechia	Revmatologicky ustav Praha /ID# 167004	Prague 2	Praha 2
Czechia	Thomayerova nemocnice /ID# 167003	Prague 4	Praha 4
Denmark	Vejle Sygehus /ID# 165190	Vejle	Syddanmark
Finland	Helsinki Univ Central Hospital /ID# 165794	Helsinki
Finland	Kiljava Medical Research /ID# 165793	Hyvinkaa
France	CHU Bordeaux-Hopital Pellegrin /ID# 166309	Bordeaux
France	CHRU Tours - Hopital Trousseau /ID# 165109	Chambray Les Tours
France	CHRU de Montpellier - Hôpital Lapeyronie /ID# 166308	Montpellier
Germany	Kerckhoff Klinik GmbH /ID# 165158	Bad Nauheim
Germany	Charite - Campus Benjamin Franklin Medizinische Klinik - Rheumatologie /ID# 165153	Berlin
Germany	Hamburger Rheuma Forschungszentrum II im MVZ Rheumatologie und Autoimmunmedizin /ID# 165146	Hamburg
Germany	Rheumazentrum Ruhrgebiet /ID# 165148	Herne	Nordrhein-Westfalen
Hungary	Revita Reumatologiai Rendelo /ID# 164724	Budapest
Hungary	University of Debrecen /ID# 165674	Debrecen
Hungary	Vita Verum Medical Bt. /ID# 165066	Szekesfehervar
Hungary	Vital Medical Center Orvosi-es Fogaszati Kozpont /ID# 164741	Veszprem
Italy	Ospedale Sant Orsola Malpighi /ID# 165692	Bologna	Emilia-Romagna
Italy	ASST G. Pini /ID# 165715	Milan
Italy	Policlinico Paolo Giaccone /Id# 165663	Palermo	Sicilia
Italy	A.O. Universitaria Senese /ID# 165716	Siena
Japan	National Hospital Organization Asahikawa Medical Center /ID# 164566	Asahikawa-shi	Hokkaido
Japan	Juntendo University Hospital /ID# 164738	Bunkyo-ku	Tokyo
Japan	St.Luke's International Hospital /ID# 165219	Chuo-ku	Tokyo
Japan	Saitama Medical University Hospital /ID# 164577	Iruma-gun	Saitama
Japan	National Hospital Organization Osaka Minami Medical Center /ID# 164365	Kawachinagano-shi	Osaka
Japan	Kagawa University Hospital /ID# 167517	Kita-gun	Kagawa
Japan	Hospital of the University of Occupational and Environmental Health /ID# 164380	Kitakyushu-shi	Fukuoka
Japan	Juntendo University Koshigaya Hospital /ID# 165809	Koshigaya-shi	Saitama
Japan	Gunma University Hospital /ID# 165683	Maebashi-shi	Gunma
Japan	Shinshu University Hospital /ID# 165304	Matsumoto-shi	Nagano
Japan	Daido Hospital /ID# 163886	Nagoya
Japan	Kochi Medical School Hospital /ID# 164460	Nankoku-shi	Kochi
Japan	Okayama Saiseikai Outpatient Center Hospital /ID# 165595	Okayama
Japan	Japanese Red Cross Okayama Hospital /ID# 164376	Okayama-shi	Okayama
Japan	Osaka City University Hospital /ID# 165253	Osaka-shi	Osaka
Japan	Osaka University Hospital /ID# 166033	Suita-shi	Osaka
Japan	Tokushima University Hospital /ID# 165108	Tokushima-shi	Tokushima
Korea, Republic of	Chonnam National University Hospital /ID# 164541	Gwangju	Jeonranamdo
Korea, Republic of	Gachon University Gil Medical Center /ID# 165114	Incheon	Incheon Gwang Yeogsi
Korea, Republic of	Chungnam National University Hospital /ID# 164561	Jung-gu	Daejeon Gwang Yeogsi
Korea, Republic of	Hanyang University Seoul Hospi /ID# 165811	Seongdong-gu	Seoul Teugbyeolsi
Korea, Republic of	Asan Medical Center /ID# 164557	Seoul
Korea, Republic of	Cath Univ Seoul St Mary's Hosp /ID# 164549	Seoul	Seoul Teugbyeolsi
Korea, Republic of	Kyunghee University Hospital at Gangdong /ID# 164569	Seoul
Netherlands	Universitair Medisch Centrum Groningen /ID# 165681	Groningen
Netherlands	Medisch Centrum Leeuwarden /ID# 166937	Leeuwarden
New Zealand	Middlemore Hospital /ID# 169241	Auckland
New Zealand	Waikato Hospital /ID# 169242	Hamilton	Waikato
Poland	Osteo-Medic S.C. /ID# 165646	Bialystok	Podlaskie
Poland	ETYKA-Osrodek Badan Klinicznyc /ID# 165634	Olsztyn	Warminsko-mazurskie
Poland	NZOZ Nasz Lekarz /ID# 166023	Torun
Portugal	Centro Hospitalar Lisboa Ocidental, EPE /ID# 168312	Lisbon	Lisboa
Portugal	Hospital CUF Descobertas /ID# 168311	Lisbon
Portugal	Instituto Portugues De Reumatologia /ID# 168314	Lisbon	Lisboa
Portugal	Unidade Local De Saude Do Alto Minho /ID# 168310	Viana Do Castelo
Portugal	Centro Hospitalar de Vila Nova Gaia/Espinho, EPE /ID# 168313	Vila Nova De Gaia	Porto
Spain	Corporac Sanitaria Parc Tauli /ID# 165029	Barcelona
Spain	Hospital Parc de Salut del Mar /ID# 165027	Barcelona
Spain	Hospital Unversitario Marques de Valdecilla /ID# 165028	Santander	Cantabria
Sweden	Skanes Universitetssjukhus /ID# 165712	Malmö	Skane Lan
Sweden	Reumatologkliniken /ID# 165713	Vaesteras
United Kingdom	Royal National Hosp for Rheuma /ID# 165147	Bath
United Kingdom	Glasgow Royal Infirmary /ID# 165152	Glasgow
United Kingdom	Whipps Cross Univ Hospital /ID# 165150	London	London, City Of
United Kingdom	Norfolk and Norwich Univ Hosp /ID# 165149	Norwich	Norfolk
United Kingdom	Warrington and Halton Hospitals NHS Foundation Trust /ID# 166202	Warrington	Cheshire West And Chester
United States	Diagnostic Group Integrated He /ID# 165195	Beaumont	Texas
United States	David S. Hallegua MD /ID# 165090	Beverly Hills	California
United States	Bay Area Arthritis and Osteo /ID# 165023	Brandon	Florida
United States	DJL Clinical Research, PLLC /ID# 165044	Charlotte	North Carolina
United States	Arth and Osteo Clin Brazo Valley /ID# 165194	College Station	Texas
United States	Covina Arthritis Clinic /ID# 165061	Covina	California
United States	Henry Ford Health System /ID# 165515	Detroit	Michigan
United States	Altoona Ctr Clinical Res /ID# 164470	Duncansville	Pennsylvania
United States	St. Joseph Health System /ID# 166166	Fullerton	California
United States	Aa Mrc Llc /Id# 165100	Grand Blanc	Michigan
United States	Comprehensive Arthritis Care, a division of Comprehensive Rheumatology Care PLLC /ID# 168107	Hendersonville	Tennessee
United States	Colorado Arthritis Associates /ID# 164444	Lakewood	Colorado
United States	Global Research Foundation /ID# 165130	Los Angeles	California
United States	St. Lukes Clinic /ID# 165827	Meridian	Idaho
United States	LeJenue Research Associates /ID# 165202	Miami	Florida
United States	HMD Research LLC /ID# 205172	Orlando	Florida
United States	Arizona Arthritis & Rheumatolo /ID# 164446	Phoenix	Arizona
United States	AZ Arthritis and Rheumotology Research, PLLC /ID# 165705	Phoenix	Arizona
United States	St. Lawrence Health System /ID# 165025	Potsdam	New York
United States	Rheumatology Center of San Diego /ID# 166167	San Diego	California
United States	Clinical Investigation Specialists - Skokie /ID# 164385	Skokie	Illinois
United States	Clinical Research Ctr Reading /ID# 164876	Wyomissing	Pennsylvania

Sponsors (1)

Lead Sponsor	Collaborator
AbbVie

Countries where clinical trial is conducted

United States,  Australia,  Belgium,  Canada,  Croatia,  Czechia,  Denmark,  Finland,  France,  Germany,  Hungary,  Italy,  Japan,  Korea, Republic of,  Netherlands,  New Zealand,  Poland,  Portugal,  Spain,  Sweden,  United Kingdom, 

References & Publications (1)

van der Heijde D, Song IH, Pangan AL, Deodhar A, van den Bosch F, Maksymowych WP, Kim TH, Kishimoto M, Everding A, Sui Y, Wang X, Chu AD, Sieper J. Efficacy and safety of upadacitinib in patients with active ankylosing spondylitis (SELECT-AXIS 1): a multicentre, randomised, double-blind, placebo-controlled, phase 2/3 trial. Lancet. 2019 Dec 7;394(10214):2108-2117. doi: 10.1016/S0140-6736(19)32534-6. Epub 2019 Nov 12. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Percentage of Participants With Assessment of SpondyloArthritis International Society (ASAS) 40 Response at Week 14	ASAS 40 response was defined as improvement of = 40% relative to Baseline and absolute improvement of = 2 units (on a scale from 0 to 10) in = 3 of the following 4 domains with no deterioration (defined as a net worsening of > 0 units) in the potential remaining domain: Patient's global assessment of disease activity, measured on a numeric rating scale (NRS) from 0 (no activity) to 10 (severe activity); Pain, measured by the total back pain NRS from 0 (no pain) to 10 (most severe pain); Function, measured by the Bath Ankylosing Spondylitis Functional Index (BASFI) which consists of 10 items assessing participants' ability to perform activities on an NRS ranging from 0 (easy) to 10 (impossible); Inflammation, measured by the mean of the 2 morning stiffness-related Bath AS Disease Activity Index (BASDAI) NRS scores (items 5 [level of stiffness] and 6 [duration of stiffness]) each on a scale from 0 (none/0 hours) to 10 (very severe/2 hours or more duration).	Baseline and Week 14
Secondary	Change From Baseline in Ankylosing Spondylitis Disease Activity Score (ASDAS) at Week 14	ASDAS is a composite index to assess disease activity in Ankylosing Spondylitis. ASDAS combines the following 5 disease activity variables using a weighted formula: Patient's assessment of total back pain (BASDAI Question 2; NRS score 0 [none] - 10 [very severe]); Patient global assessment of disease activity (NRS score 0 [no activity] - 10 [severe activity]); Peripheral pain/swelling (BASDAI Question 3; NRS score 0 [none] - 10 [very severe]); Duration of morning stiffness (BASDAI Question 6; NRS score 0 [0 hours] - 10 [2 or more hours]); High-sensitivity C-reactive protein (hs-CRP) in mg/L.; The overall score ranges from 0 with no defined upper score; published ranges for disease activity states as defined by the ASDAS include Inactive disease (ASDAS < 1.3) and very high disease (ASDAS > 3.5). A negative change from Baseline score indicates improvement in disease activity.	Baseline and Week 14
Secondary	Change From Baseline in Spondyloarthritis Research Consortium of Canada (SPARCC) Magnetic Resonance Imaging (MRI) Score for the Spine at Week 14	In the SPARCC MRI assessment of the spine, the entire spine is evaluated for active inflammation (bone marrow edema). Six discovertebral units (DVU) representing the 6 most abnormal DVUs were selected to calculate the MRI Spine SPARCC score. For each of the 6 DVUs, 3 consecutive sagittal slices were assessed in 4 quadrants to evaluate the extent of inflammation in all three dimensions.; Each quadrant was scored for the presence (1) or absence (0) of edema. If edema was present in at least one quadrant of a DVU slice, it was also scored for intensity and depth of the edema representing that slice: An additional score of 1 was assigned if an intense signal was seen in any quadrant on a DVU slice. Slices that included a lesion demonstrating continuous increased signal of depth = 1 cm extending from the endplate were scored as an additional 1 per slice.; The maximum (worst) overall score for all 6 DVUs is 108.	Baseline and Week 14
Secondary	Percentage of Participants With Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) 50 Response at Week 14	The BASDAI assesses disease activity by asking the participant to answer 6 questions (each on an 11 point numeric rating scale [NRS]) pertaining to symptoms experienced for the past week. For Questions 1 to 5 (level of fatigue/tiredness, level of AS neck, back or hip pain, level of pain/swelling in joints, other than neck, back or hips, level of discomfort from any areas tender to touch or pressure, and level of morning stiffness), the response is from 0 (none) to 10 (very severe); for Question 6 (duration of morning stiffness), the response is from 0 (0 hours) to 10 (= 2 hours). The overall BASDAI score ranges from 0 to 10. Lower scores indicate less disease activity.; A BASDAI 50 response is defined as improvement of 50% or more from Baseline in BASDAI score.	Baseline and Week 14
Secondary	Change From Baseline in Ankylosing Spondylitis Quality of Life (ASQoL) Score	The ASQoL consists of 18 items related to quality of life, including the impact of pain on sleep, mood, motivation, ability to cope, activities of daily living, independence, relationships, and social life. Each item is answered as yes (scored as 1) or no (scored as 0).; Scores are summed to obtain the overall score which ranges from 0 to 18, where higher scores indicate a worse quality of life. A negative change from Baseline in ASQoL indicates improvement in quality of life.	Baseline and Week 14
Secondary	Percentage of Participants Achieving an Assessment of Spondyloarthritis International Society (ASAS) Partial Remission	ASAS partial remission (PR) is defined as an absolute score of = 2 units on a 0 to 10 scale for each of the four following domains: Patient's global assessment of disease activity, measured on a numeric rating scale (NRS) from 0 (no activity) to 10 (severe activity); Pain, measured by the total back pain NRS from 0 (no pain) to 10 (most severe pain); Function, measured by the Bath Ankylosing Spondylitis Functional Index (BASFI) which consists of 10 items assessing participants' ability to perform activities on an NRS ranging from 0 (easy) to 10 (impossible); Inflammation, measured by the mean of the 2 morning stiffness-related Bath AS Disease Activity Index (BASDAI) NRS scores (items 5 [level of stiffness] and 6 [duration of stiffness]) each on a scale from 0 (none/0 hours) to 10 (very severe/2 hours or more duration).	Week 14
Secondary	Change From Baseline in Bath Ankylosing Spondylitis Functional Index (BASFI) at Week 14	The Bath Ankylosing Spondylitis Functional Index is a validated index to determine the degree of functional limitation in patients with AS. BASFI consists of 10 questions assessing participants' ability to perform activities such as putting on socks, bending, reaching, getting up from the floor or an armless chair, standing, climbing and other physical activities. Each item is scored on a NRS ranging from 0 (easy to perform an activity) to 10 (impossible to perform an activity). The overall score is the mean of the 10 items and ranges from 0 to 10 with higher scores indicating more functional limitations. A negative change from Baseline in BASFI indicates improvement.	Baseline and Week 14
Secondary	Change From Baseline in Linear Bath Ankylosing Spondylitis Metrology Index (BASMI[Lin]) at Week 14	The BASMI is a composite score based on 5 direct measurements of spinal mobility: cervical rotation (measured in degrees),; tragus to wall distance (in centimeters [cm]); lumbar side flexion (in cm),; lumbar flexion (modified Schober's) (in cm) and; intermalleolar distance (in cm).; Each measurement is converted to a linear score between 0 and 10. The total BASMI score is the average of the 5 scores and ranges from 0 to 10; the higher the BASMI score the more severe the patient's limitation of movement due to their ankylosing spondylitis. A negative change from Baseline indicates improvement.	Baseline and Week 14
Secondary	Change From Baseline in Maastricht Ankylosing Spondylitis Enthesitis Score (MASES) at Week 14	The MASES evaluation was conducted to assess the presence or absence of enthesitis (inflammation of the entheses, or sites where tendons or ligaments insert into the bone) at 13 different sites (first costochondral joint left/right, seventh costochondral joint left/right, posterior superior iliac spine left/right, anterior superior iliac spine left/right, iliac crest left/right, fifth lumbar spinous process, and proximal insertion of Achilles tendon left/right. Each site was scored for presence (1) or absence (0) of enthesitis. The MASES is the sum of the 13 site scores, and ranges from 0 to 13, with higher scores indicating more inflammation of the entheses.	Baseline and Week 14
Secondary	Change From Baseline in Work Productivity and Activity Impairment (WPAI) Overall Work Impairment at Week 14	The Work Productivity and Activity Impairment Questionnaire: Axial Spondyloarthritis, Version 2.0 (WPAI-Axial Spondyloarthritis) measures the effect of overall health and specific symptoms on productivity at work and outside of work. It consists of 6 questions. Respondents were asked about time missed from work and time while at work during which productivity was impaired in the past seven days. Results of WPAI are expressed as a percentage of impairment from 0 to 100, with higher percentages indicating greater impairment and less productivity. Overall Work Impairment indicates the percentage of overall work impairment due to health problems. A negative change from Baseline indicates improvement.	Baseline and Week 14
Secondary	Change From Baseline in ASAS Health Index (HI) at Week 14	The ASAS HI measures functioning and health across 17 aspects of health in patients with AS, including pain, emotional functions, sleep, sexual function, mobility, self care, and community life. Each of the 17 questions is answered by the participant as "I agree" (score = 1) or "I disagree" (score = 0). The responses to the 17 dichotomous items are summed up to give a total score ranging from 0 to 17, where a higher score indicates a worse health status. A negative change from Baseline indicates improvement.	Baseline and Week 14
Secondary	Percentage of Participants Achieving an ASAS 20 Response at Week 14	ASAS 20 response was defined as an improvement of = 20% and an absolute improvement of = 1 unit (on a scale of 0 to 10) from Baseline in at least 3 of the following 4 domains, with no deterioration (defined as a worsening of = 20% and a net worsening of = 1 units [on a scale of 0 to 10]) in the remaining domain: Patient's global assessment of disease activity, measured on a NRS from 0 (no activity) to 10 (severe activity); Pain, measured by the total back pain NRS from 0 (no pain) to 10 (most severe pain); Function, measured by the BASFI which consists of 10 items assessing participants' ability to perform activities on an NRS ranging from 0 (easy) to 10 (impossible); Inflammation, measured by the mean of the 2 morning stiffness-related BASDAI NRS scores (items 5 [level of stiffness] and 6 [duration of stiffness]) each on a scale from 0 (none/0 hours) to 10 (very severe/2 hours or more duration).	Baseline and Week 14
Secondary	Change From Baseline in SPARCC MRI Score for Sacroiliac Joints at Week 14	In the SPARCC MRI assessment of the sacroiliac (SI) joints 6 consecutive sacroiliac joint image coronal slices representing the largest proportion of the synovial compartment of the SI joints were assessed for edema, intensity and depth of edema.; Each SI joint (left and right) was divided into quadrants for a total of 8 SI scoring locations. Each quadrant was scored for the presence (1) or absence (0) of edema, intensity of edema (a score of 1 was assigned for each SI joint (left and right) if an intense signal was seen in any quadrant of that joint for each slice), and a lesion was graded as deep (score of 1) if there was homogeneous and unequivocal increase in signal extending over a depth of at least 1 cm from the articular surface of the SI joint in any quadrant.; The total maximum score for all SI joints across 6 slices is 72.	Baseline and Week 14