- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02407223
An Efficacy and Safety Study of Ustekinumab in Participants With Active Nonradiographic Axial Spondyloarthritis
March 11, 2019 updated by: Janssen Research & Development, LLC
A Phase 3, Multicenter, Randomized, Double-blind, Placebo-controlled Study Evaluating the Efficacy and Safety of Ustekinumab in the Treatment of Subjects With Active Nonradiographic Axial Spondyloarthritis
The purpose of this study is to assess the efficacy and safety of ustekinumab in adult participants with active nonradiographic axial spondyloarthritis (nr-AxSpA) measured by the reduction in signs and symptoms of nonradiographic axial spondyloarthritis (nr-AxSpA).
Study Overview
Status
Terminated
Intervention / Treatment
Detailed Description
This is a phase 3, multicenter, randomized, double-blind, placebo-controlled study evaluating the efficacy and safety of ustekinumab in the treatment of participants with active non-radiographic axial spondylo arthritis.
Participants will receive either placebo or ustekinumab 45 or 90 milligram (mg).
Participants will primarily be assessed for Assessment of Spondylo Arthritis (ASAS) International Society criteria 20 at Week 24.
Safety will be monitored throughout the study.
Study Type
Interventional
Enrollment (Actual)
356
Phase
- Phase 3
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Buenos Aires, Argentina
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Ciudad De Buenos Aires, Argentina
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Ciudad De La Plata, Argentina
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Ciudad De San Miguel De Tucuman, Argentina
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Cordoba, Argentina
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Geelong, Australia
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Hobart, Australia
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Kogarah, Australia
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Queensland, Australia
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Woodville South, Australia
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Woolloongabba, Australia
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Genk, Belgium
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Gent, Belgium
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Leuven, Belgium
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Liège, Belgium
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Merksem, Belgium
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Brno, Czechia
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Bruntal, Czechia
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Kladno, Czechia
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Ostrava, Czechia
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Pardubice, Czechia
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Prague 5, Czechia
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Praha 2, Czechia
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Praha 4, Czechia
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Uherske Hradiste, Czechia
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Zlin, Czechia
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Boulogne-Billancourt, France
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Chambray Les Tours, France
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Echirolles, France
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Montpellier, Herault, France
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Paris, France
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Toulouse, France
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Bad Nauheim, Germany
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Berlin, Germany
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Hamburg, Germany
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Hannover, Germany
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Herne, Germany
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Köln, Germany
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Olsberg, Germany
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Budapest, Hungary
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Debrecen, Hungary
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Esztergom, Hungary
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Kistarcsa, Hungary
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Nyíregyháza, Hungary
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Szolnok, Hungary
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Székesfehérvár, Hungary
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Veszprem, Hungary
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Gwangju, Korea, Republic of
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Incheon, Korea, Republic of
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Seoul, Korea, Republic of
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Chihuahua, Mexico
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Culiacan, Mexico
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Guadalajara, Mexico
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Mexico, Mexico
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Bydgoszcz, Poland
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Szczecin, Poland
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Torun, Poland
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Warszawa, Poland
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Wrocław, Poland
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Chelyabinsk, Russian Federation
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Chita, Russian Federation
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Kemerovo, Russian Federation
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Kirov, Russian Federation
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Moscow, Russian Federation
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Novosibirsk, Russian Federation
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Orenburg, Russian Federation
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Petrozavodsk, Russian Federation
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Sankt-Petersburg., Russian Federation
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Saratov, Russian Federation
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St.Petersburg, Russian Federation
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Stavropol, Russian Federation
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Ulyanovsk, Russian Federation
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Zelenograd, Russian Federation
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Kaohsiung, Taiwan
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Taichung, Taiwan
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Tainan, Taiwan
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Taipei, Taiwan
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Taoyuan, Taiwan
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Ivano-Frankivsk, Ukraine
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Kharkiv, Ukraine
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Kyiv, Ukraine
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Lviv, Ukraine
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Odessa, Ukraine
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Ternopil, Ukraine
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Vinnytsya, Ukraine
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Zaporizhzhya, Ukraine
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Bath, United Kingdom
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Leeds, United Kingdom
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Leytonstone, United Kingdom
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London, United Kingdom
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Norwich, United Kingdom
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Staffordshire, United Kingdom
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Torquay, United Kingdom
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 50 years (Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Participants must be classified as having nonradiographic axial spondyloarthritis (nr-AxSpA) based on 2009 Assessment of SpondyloArthritis International Society (ASAS) criteria
- Must have an age at nr-AxSpA onset of <= 45 years
- Must have at screening or active inflammation on magnetic resonance imaging (MRI) as evidenced by the central readers and no radiographic sacroiliitis that fulfills the 1984 modified New York Criteria
- Must have symptoms of active disease at screening and at baseline, as evidenced by both a BASDAI score of >= 4 and a visual analogue scale (VAS) score for total back pain of more than or equal to (>=) 4, each on a scale of 0 to 10
Exclusion Criteria:
- Have radiographic sacroiliitis fulfilling the 1984 modified New York Criteria
- Have other inflammatory diseases that might confound the evaluations of benefit from the ustekinumab therapy
- Have received any systemic immunosuppressives or disease-modifying anti-rheumatic drug (DMARDs) other than methotrexate (MTX), sulfasalazine (SSZ), or hydroxychloroquine (HCQ) within 4 weeks prior to first administration of study agent
- Have received epidural, intra-articular, intramuscular (IM), or intravenous (IV) corticosteroids, including adrenocorticotropic hormone during the 4 weeks prior to first administration of study agent
- Have received prior biologic therapy other than anti-TNFα
- Have received more than 1 prior anti-TNFα agent
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
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Placebo Comparator: Group 1: Placebo
Participants will receive placebo subcutaneously (SC) at Weeks 0, 4, 16, and 20.
At Week 24, all participants (except those who early escaped) will crossover to receive ustekinumab 45 or 90 milligram (mg) SC at Weeks 24 and 28 followed by every 12 weeks up to Week 52.
At Week 16, participants in placebo group with < 10% improvement from baseline in both total back pain and morning stiffness measures at Week 12 and 16 will enter early escape to receive ustekinumab 45 mg or 90 mg at Weeks 16, 20, and 28 followed by every 12 weeks up to Week 52.
At Week 52, participants who achieved inactive disease by ASDAS (ESR) <1.3 at both Week 40 and 52 will be re-randomized to receive placebo or ustekinumab every 12 weeks up to Week 88.
At Week 52, participants who did not achieve inactive disease by ASDAS (ESR) <1.3 at Week 40 or 52 will continue with ustekinumab every 12 weeks up to Week 88.
NOTE: Intervention Description should have no more than 800 characters.
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Participants will receive placebo SC at Weeks 0, 4, 16, and 20.
At Week 24, all participants (except those who early escaped) will crossover to receive ustekinumab 45 or 90 mg SC at Weeks 24 and 28 followed by every 12 weeks up to Week 52.
At Week 16, participants in placebo group with < 10% improvement from baseline in both total back pain and morning stiffness measures at Week 12 and 16 will enter early escape to receive ustekinumab 45 mg or 90 mg at Weeks 16, 20, and 28 followed by every 12 weeks up to Week 52.
At Week 52, participants who achieved inactive disease by ASDAS (ESR) <1.3 at both Week 40 and 52 will be re-randomized to receive placebo or ustekinumab every 12 weeks up to Week 88.
At Week 52, participants who did not achieve inactive disease by ASDAS (ESR) <1.3 at Week 40 or 52 will continue with ustekinumab every 12 weeks up to Week 88.
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Experimental: Group 2: Ustekinumab 45 milligram (mg)
Participants will receive ustekinumab 45 mg subcutaneously at Weeks 0 and 4, followed by every 12 weeks through Week 52.
At Weeks 20 and 24, participants will receive placebo subcutaneously to maintain the blind.
At Week 52, participants who achieved inactive disease by ASDAS (ESR) <1.3 at both Week 40 and Week 52 will be re-randomized to receive either placebo or ustekinumab 45 mg every 12 weeks in a blinded fashion.
At Week 52, participants who did not achieve inactive disease by ASDAS (ESR) <1.3 at Week 40 or Week 52 will continue receiving ustekinumab 45 mg every 12 weeks through Week 88.
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Participants will receive ustekinumab 45 mg subcutaneously at Weeks 0 and 4, followed by every 12 weeks through Week 52.
At Weeks 20 and 24, participants will receive placebo subcutaneously to maintain the blind.
At Week 52, participants who achieved inactive disease by ASDAS (ESR) <1.3 at both Week 40 and Week 52 will be re-randomized to receive either placebo or ustekinumab 45 mg every 12 weeks in a blinded fashion.
At Week 52, participants who did not achieve inactive disease by ASDAS (ESR) <1.3 at Week 40 or Week 52 will continue receiving ustekinumab 45 mg every 12 weeks through Week 88.
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Experimental: Group 3: Ustekinumab 90 mg
Participants will receive ustekinumab 90 mg subcutaneously at Weeks 0 and 4, followed by every four weeks through Week 52.
At Weeks 20 and 24, participants will receive placebo subcutaneously to maintain the blind.
At Week 52, participants who achieved inactive disease by ASDAS (ESR) <1.3 at both Week 40 and Week 52 will receive either placebo or ustekinumab 90 mg every 12 weeks in a blinded fashion.
At Week 52, participants who did not achieve inactive disease by ASDAS (ESR) <1.3 at Week 40 or Week 52 will continue receiving ustekinumab 90 mg every 12 weeks through Week 88.
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Participants will receive ustekinumab 90 mg subcutaneously at Weeks 0 and 4, followed by every four weeks through Week 52.
At Weeks 20 and 24, participants will receive placebo subcutaneously to maintain the blind.
At Week 52, participants who achieved inactive disease by ASDAS (ESR) <1.3 at both Week 40 and Week 52 will receive either placebo or ustekinumab 90 mg every 12 weeks in a blinded fashion.
At Week 52, participants who did not achieve inactive disease by ASDAS (ESR) <1.3 at Week 40 or Week 52 will continue receiving ustekinumab 90 mg every 12 weeks through Week 88.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
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Percentage of Participants Who Achieved Assessment of SpondyloArthritis International Society (ASAS) 20 Response at Week 24
Time Frame: Week 24
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ASAS 20 defined as improvement of greater than or equal to (>=) 20 % from baseline and absolute improvement from baseline of 1 on a 0 to 10 centimeter(cm) scale in at least 3 of following 4 domains: Patient's global assessment of disease activity (0 to 10 cm; 0=very well,10=very poor), total back pain (0 to 10 cm; 0=no pain,10=most severe pain), BASFI (self-assessment represented as mean (0 to 10 cm; 0=easy to 10=impossible) of 10 questions, 8 of which relate to participant's functional anatomy and 2 to participant's ability to cope with everyday life), Inflammation (0 to 10 cm;0=none,10=very severe); absence of deterioration (>= 20% and worsening of at least 1 on a 0 to 10 cm scale) from baseline in remaining domain.
ASAS20 response based on imputed data using treatment failure (consider non-responders at and after treatment failure),early escape rules (consider non-responder at Week 20 and 24),non-responder[NRI] (missing responses at post baseline visit imputed as non-responder).
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Week 24
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
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Percentage of Participants Who Achieved an ASAS 40 Response at Week 24
Time Frame: Week 24
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ASAS 40 defined as improvement of >= 40% from baseline and absolute improvement from baseline of at least 2 on 0 to 10 cm scale in at least 3 of following 4 domains: Patient's global assessment of disease activity (0 to 10 cm; 0=very well,10=very poor),total back pain (0 to 10 cm; 0=no pain,10=most severe pain), BASFI (self-assessment represented as mean (0 to 10 cm; 0=easy to 10=impossible) of 10 questions, 8 of which relate to participant's functional anatomy and 2 relate to participant's ability to cope with everyday life), Inflammation (0 to 10 cm; 0=none,10=very severe); no worsening at all from baseline in remaining domain.
ASAS40 response based on imputed data using treatment failure(consider non-responders at and after treatment failure),early escape rules(consider non-responder at Week 20 and 24),non-responder[NRI] (missing responses at post baseline visit imputed as non-responder).
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Week 24
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Percentage of Participants Who Achieved at Least a 50% Improvement From Baseline in Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) at Week 24
Time Frame: Week 24
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The BASDAI is used to measure the ankylosing spondylitis (AS) disease severity.
It consists of 6 questions: fatigue, spinal pain, arthralgia (joint pain) or swelling, enthesitis (inflammation of tendons and ligaments), and morning stiffness (2 questions: duration and severity).
Each question is an easy to answer 10 centimeter (cm) visual analog scale (VAS), with 0 being none, and 10 being very severe.
In order to give each of the 5 symptoms equal weight, the mean of the 2 questions about morning stiffness were added to the total of the remaining 4 scores, and the final BASDAI score (ranging 0-10) is the average of the overall total score.
Higher BASDAI score indicates more severe AS symptom.
50% improvement in response based on imputed data using treatment failure(consider non-responders at and after treatment failure),early escape rules(consider non-responder at Week 20 and 24), non-responder[NRI] (missing responses at post baseline visit imputed as non-responder).
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Week 24
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Change From Baseline in Bath Ankylosing Spondylitis Functional Index (BASFI) at Week 24
Time Frame: Baseline, Week 24
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The BASFI is composed with 10 questions (each question is answered with a visual analogue scale 0-10 cm) to assess the disease severity, including the first 8 questions regarding to functional anatomy related activities and the remaining 2 questions related to daily activities of ankylosing spondylitis participants.
Each question is a 10cm VAS with a value between 0 (easy) and 10 (impossible).
The final BASFI score is the mean of the 10 scores.
The BASFI score is the average of the 10 responses and has a possible minimum value of 0 and a possible maximum value of 10.
Higher BASFI score indicates more severe functional limitations of the participant due to AS.
Early escape rule was applied (measurement value at Week 20 and Week 24 was set as missing).
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Baseline, Week 24
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Percentage of Participants Who Achieved Ankylosing Spondylitis Disease Activity Score (ASDAS) C-reactive Protein (CRP) Inactive Disease (<1.3) at Week 24
Time Frame: Week 24
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ASDAS includes CRP milligram per liter (mg/L); four additional self-reported items (rated on 0-10cm VAS or 0-10 numerical rating scale [NRS]) included total back pain(TBP), duration of morning stiffness (DMS), peripheral pain/swelling and patient global assessment(PGA).
ASDAS scores calculated as: ASDAS(CRP) = (0.121*total back pain)+ (0.110*PGA)+ (0.073*peripheral pain/swelling)+ (0.058* DMS)+ (0.579*Ln(CRP+1)).
The disease activity, TBP, and peripheral pain/swelling on a numeric rating scale (from 0 (normal) to 10 (very severe)) and DMS on a numeric rating scale (0 to 10, with 0 being none and 10 representing a duration of =>2 hours).
Inactive disease is defined as an ASDAS score <1.3.
ASDAS (CRP) Inactive Disease is based on imputed data using treatment failure(consider non-responders at and after treatment failure),early escape rules(consider non-responder at Week 20 and 24), NRI (missing responses at post baseline visit imputed as non-responder).
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Week 24
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Change From Baseline in High Sensitivity C-Reactive Protein (hsCRP) Levels Through Week 24
Time Frame: Baseline, Week 4, 8, 12, 16, 20 and 24
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Change from baseline in hsCRP levels was reported.
hsCRP is a sensitive laboratory assay for serum levels of C-Reactive Protein, which is a biomarker of inflammation.
Early escape rule was applied (measurement value at Week 20 and Week 24 was set as missing).
Here 'n' signifies the number of participants who were analyzed at each specified timepoints, for each arm, respectively.
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Baseline, Week 4, 8, 12, 16, 20 and 24
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Percentage of Participants With ASAS 20 Components at Week 24
Time Frame: Week 24
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ASAS 20 defined as >= 20% improvement from baseline in 4 individual components of ASAS20: Patient's global assessment (PGA) of disease activity (0 to 10cm; 0=very well,10=very poor), total back pain(0 to 10cm; 0=no pain,10=most severe pain), BASFI (self-assessment represented as mean(0 to10 cm; 0=easy to 10=impossible) of 10 questions, 8 of which relate to functional anatomy and 2 relate to participant's ability to cope with life) and Inflammation (0 to 10cm;0=none,10=very severe).
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Week 24
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Percentage of Participants Who Achieved ASAS 40 Response at Week 4, 8, 12, 16 and 20
Time Frame: Week 4, 8, 12, 16 and 20
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ASAS 40 defined as improvement of >= 40% from baseline and absolute improvement from baseline of at least 2 on 0 to10cm scale in at least 3 of following 4 domains: Patient's global assessment of disease activity (0 to 10cm; 0=very well,10=very poor),total back pain (0 to 10cm; 0=no pain,10=most severe pain), BASFI (self-assessment represented as mean (0 to 10 cm; 0=easy to 10=impossible) of 10 questions, 8 of which relate to participant's functional anatomy and 2 relate to participant's ability to cope with everyday life), Inflammation (0 to 10cm;0=none,10=very severe); no worsening at all from baseline in remaining domain.
ASAS40 response based on imputed data using treatment failure (consider non-responders at and after treatment failure), early escape rules(consider non-responder at Week 20 and 24),non-responder[NRI] (missing responses at post baseline visit imputed as non-responder).
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Week 4, 8, 12, 16 and 20
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Percentage of Participants Who Achieved ASAS 20 Response at Week 4, 8, 12, 16 and 20
Time Frame: Week 4, 8, 12, 16 and 20
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ASAS 20 defined as improvement of >= 20 % from baseline and absolute improvement from baseline of 1 on a 0 to 10 cm scale in at least 3 of following 4 domains: Patient's global assessment of disease activity (0 to 10 cm; 0=very well,10=very poor), total back pain (0 to 10 cm; 0=no pain,10=most severe pain), BASFI (self-assessment represented as mean (0 to 10 cm; 0=easy to 10=impossible) of 10 questions, 8 of which relate to participant's functional anatomy and 2 to participant's ability to cope with everyday life), Inflammation (0 to 10 cm;0=none,10=very severe); absence of deterioration (>= 20% and worsening of at least 1 on a 0 to 10 cm scale) from baseline in remaining domain.
ASAS20 response based on imputed data using treatment failure (consider non-responders at and after treatment failure),early escape rules (consider non-responder at Week 20 and 24),non-responder[NRI] (missing responses at post baseline visit imputed as non-responder).
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Week 4, 8, 12, 16 and 20
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Percentage of Participants Who Achieved at Least a 50% Improvement From Baseline in BASDAI at Week 4, 8, 12, 16 and 20
Time Frame: Week 4, 8, 12, 16, and 20
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The BASDAI is used to measure the ankylosing spondylitis (AS) disease severity.
It consists of 6 questions: fatigue, spinal pain, arthralgia (joint pain) or swelling, enthesitis (inflammation of tendons and ligaments), and morning stiffness (2 questions: duration and severity).
Each question is an easy to answer 10 centimeter (cm) visual analog scale (VAS), with 0 being none, and 10 being very severe.
In order to give each of the 5 symptoms equal weight, the mean of the 2 questions about morning stiffness will be added to the total of the remaining 4 scores, and the final BASDAI score (ranging 0-10) is the average of the overall total score.
Higher BASDAI score indicates more severe AS symptom.
50% improvement in BASDAI based on imputed data using treatment failure(consider non-responders at and after treatment failure),early escape rules(consider non-responder at Week 20 and 24), NRI(missing responses at post baseline visit imputed as non-responders).
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Week 4, 8, 12, 16, and 20
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Change From Baseline in Bath Ankylosing Spondylitis Functional Index (BASFI) at Week 4, 8, 12, 16 and 20
Time Frame: Baseline, Week 4, 8, 12, 16 and 20
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The BASFI is composed with 10 questions (each question is answered with a visual analogue scale 0-10 cm) to assess the disease severity, including the first 8 questions regarding to functional anatomy related activities and the remaining 2 questions related to daily activities of AS participants.
Each question is a 10cm VAS with a value between 0 (easy) and 10 (impossible).
The final BASFI score is the mean of the 10 scores.
The BASFI score is the average of the 10 responses and has a possible minimum value of 0 and a possible maximum value of 10.
Higher BASFI score indicates more severe functional limitations of the participant due to AS. Missing data were imputed using early escape rule (measurement value at Week 20 and 24 was set as missing).
Here 'n' defined as number of participants who were analyzed at each specified timepoint, for each arm, respectively.
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Baseline, Week 4, 8, 12, 16 and 20
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Percentage of Participants With ASDAS (CRP) Inactive Disease (<1.3) at Week 4, 8, 12, 16, and 20
Time Frame: Week 4, 8, 12, 16, and 20
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ASDAS includes CRP mg/L; four additional self-reported items (rated on 0-10cm VAS or 0-10 numerical rating scale [NRS]) included total back pain(TBP), duration of morning stiffness (DMS), peripheral pain/swelling and patient global assessment(PGA).
ASDAS scores calculated as: ASDAS(CRP) = (0.121*total back pain)+ (0.110*PGA)+ (0.073*peripheral pain/swelling)+ (0.058* DMS)+ (0.579*Ln(CRP+1)).
The disease activity, TBP, and peripheral pain/swelling on a numeric rating scale (from 0 (normal) to 10 (very severe)) and DMS on a numeric rating scale (0 to 10, with 0 being none and 10 representing a duration of =>2 hours).
Inactive disease is defined as an ASDAS score <1.3.
ASDAS (CRP) Inactive Disease is based on imputed data using treatment failure(consider non-responders at and after treatment failure),early escape rules(consider non-responder at Week 20 and 24), NRI (missing responses at post baseline visit imputed as non-responder).
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Week 4, 8, 12, 16, and 20
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
July 13, 2015
Primary Completion (Actual)
September 26, 2017
Study Completion (Actual)
September 26, 2017
Study Registration Dates
First Submitted
March 30, 2015
First Submitted That Met QC Criteria
April 1, 2015
First Posted (Estimate)
April 2, 2015
Study Record Updates
Last Update Posted (Actual)
March 13, 2019
Last Update Submitted That Met QC Criteria
March 11, 2019
Last Verified
February 1, 2019
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- CR106995
- CNTO1275AKS3003 (Other Identifier: Janssen Research & Development, LLC)
- 2015-000289-67 (EudraCT Number)
Drug and device information, study documents
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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