A Study to Evaluate the Efficacy and Safety of Ustekinumab in the Treatment of Anti-TNF(Alpha) Refractory Participants With Active Radiographic Axial Spondyloarthritis

• ClinicalTrials.gov Identifier: NCT02438787
• Recruitment Status: Terminated
• First Posted: May 8, 2015
• Results First Posted: October 1, 2018
• Last Update Posted: August 28, 2019
• Sponsor: Janssen Research & Development, LLC
• Information provided by (Responsible Party): Janssen Research & Development, LLC

Study Description

Brief Summary:

The purpose of this study is to assess the efficacy of ustekinumab, in adult anti-TNF(alpha) refractory participants with active radiographic axial spondyloarthritis (AxSpA), as measured by the reduction in signs and symptoms of radiographic AxSpA.

Condition or disease	Intervention/treatment	Phase
Axial Spondyloarthritis	Drug: Placebo; Drug: Ustekinumab 45 mg; Drug: Ustekinumab 90 mg; Drug: Golimumab 50 mg	Phase 3

Detailed Description:

This is a Phase 3, multicenter (when more than one hospital or medical school team work on a medical research study), randomized (study medication assigned to participants by chance), double-blind (neither the researchers nor the participants know what treatment the participant is receiving), placebo-controlled (an inactive substance; a pretend treatment [with no drug in it] that is compared in a clinical trial with a drug to test if the drug has a real effect) study. The study consists of 3 phases; Screening (up to 8 weeks), Treatment phase: placebo-controlled (Week 0 to 24) and active treatment (Week 24 to Week 52), and Safety Follow-up (up to 12 weeks). Participants will be randomly assigned to 1 of 3 treatment groups: placebo, ustekinumab 45 mg and ustekinumab 90 mg. The total duration of study will be up to 64 weeks. Participants will be primarily assessed for Assessment of SpondyloArthritis International Society (ASAS) 40 response at Week 24. Participants' safety will be monitored throughout the trial.

Study Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 315 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
• Primary Purpose: Treatment
• Official Title: A Phase 3, Multicenter, Randomized, Double-blind, Placebo-controlled Study Evaluating the Efficacy and Safety of Ustekinumab in the Treatment of Anti-TNF(Alpha) Refractory Subjects With Active Radiographic Axial Spondyloarthritis
• Actual Study Start Date: July 31, 2015
• Actual Primary Completion Date: August 31, 2017
• Actual Study Completion Date: August 31, 2017

Arms and Interventions

Arm	Intervention/treatment
Placebo Comparator: Group 1 (placebo); Placebo subcutaneous (SC) injection at Weeks 0, 4, and 16. At Week 24 all participants (with the exception of participants who qualified for early escape [EE]) will be re-randomized to receive either ustekinumab 45 or 90 milligram (mg) SC injection at Weeks 24 and 28 followed by every 12 weeks (q12w) dosing, with the last administration of study agent at Week 52. Participants who meet EE criteria (less than [<] 10 percent [%] improvement from baseline in both total back pain and morning stiffness measures at both Week 12 and Week 16) will be administered open-label golimumab 50 mg SC administrations at Week 16 and every 4 weeks (q4w) thereafter through Week 52.	Drug: Placebo; Placebo subcutaneous (SC) injection at Weeks 0, 4, and 16 in Group 1.; Drug: Ustekinumab 45 mg; Ustekinumab 45 mg SC injection at Weeks 24 and 28 followed by every 12 weeks (q12w) dosing, with the last administration of study agent at Week 52 in Group 1. Participants will start with ustekinumab 45 mg SC injection at Weeks 0 and 4, followed by q12w dosing, with the last administration of study agent at Week 52 in Group 2.; Drug: Ustekinumab 90 mg; Ustekinumab 90 mg SC injection at Weeks 24 and 28 followed by q12w dosing, with the last administration of study agent at Week 52 in Group 1. Participants will start with ustekinumab 90 mg SC injection at Weeks 0 and 4, followed by q12w dosing, with the last administration of study agent at Week 52 in Group 3.; Drug: Golimumab 50 mg; Participants who meet EE criteria (less than [<] 10 percent [%] improvement from baseline in both total back pain and morning stiffness measures at both Week 12 and Week 16) will be administered open-label golimumab 50 mg SC administrations at Week 16 and every 4 weeks (q4w) thereafter through Week 52 in Group 1, 2 and 3.
Experimental: Group 2 (ustekinumab 45 mg); Ustekinumab 45 mg SC injection at Weeks 0 and 4, followed by q12w dosing, with the last administration of study agent at Week 52. At Week 24, participants will receive placebo SC injection to maintain the blind. Participants who meet EE criteria (<10% improvement from baseline in both total back pain and morning stiffness measures at both Week 12 and Week 16) will be administered open-label golimumab 50 mg SC administrations at Week 16 and q4w thereafter through Week 52.	Drug: Ustekinumab 45 mg; Ustekinumab 45 mg SC injection at Weeks 24 and 28 followed by every 12 weeks (q12w) dosing, with the last administration of study agent at Week 52 in Group 1. Participants will start with ustekinumab 45 mg SC injection at Weeks 0 and 4, followed by q12w dosing, with the last administration of study agent at Week 52 in Group 2.; Drug: Golimumab 50 mg; Participants who meet EE criteria (less than [<] 10 percent [%] improvement from baseline in both total back pain and morning stiffness measures at both Week 12 and Week 16) will be administered open-label golimumab 50 mg SC administrations at Week 16 and every 4 weeks (q4w) thereafter through Week 52 in Group 1, 2 and 3.
Experimental: Group 3 (ustekinumab 90 mg); Ustekinumab 90 mg SC injection at Weeks 0 and 4, followed by q12w dosing, with the last administration of study agent at Week 52. At Week 24, participants will receive placebo SC injection to maintain the blind. Participants who meet EE criteria (<10% improvement from baseline in both total back pain and morning stiffness measures at both Week 12 and Week 16) will be administered open-label golimumab 50 mg SC administrations at Week 16 and q4w thereafter through Week 52.	Drug: Ustekinumab 90 mg; Ustekinumab 90 mg SC injection at Weeks 24 and 28 followed by q12w dosing, with the last administration of study agent at Week 52 in Group 1. Participants will start with ustekinumab 90 mg SC injection at Weeks 0 and 4, followed by q12w dosing, with the last administration of study agent at Week 52 in Group 3.; Drug: Golimumab 50 mg; Participants who meet EE criteria (less than [<] 10 percent [%] improvement from baseline in both total back pain and morning stiffness measures at both Week 12 and Week 16) will be administered open-label golimumab 50 mg SC administrations at Week 16 and every 4 weeks (q4w) thereafter through Week 52 in Group 1, 2 and 3.

Outcome Measures

Primary Outcome Measures :

1. Percentage of Participants Who Achieved an Assessment of SpondyloArthritis International Society (ASAS) 40 Response at Week 24 [ Time Frame: Week(W) 24 ]
   ASAS 40 defined as improvement from baseline of greater than or equal to (>=) 40% and with an absolute improvement from baseline of at least 2 on 0 to10cm scale in at least 3 of following 4 domains: Patient's global assessment (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(non responder imputation)] (missing responses at post baseline visit imputed as non-responder).

Secondary Outcome Measures :

1. Percentage of Participants Who Achieved an ASAS 20 Response at Week 24 [ Time Frame: Week 24 ]
   ASAS 20 defined as improvement from baseline of >= 20% from baseline and with an 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 (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); absence of deterioration (>= 20% and worsening of at least 1 on a 0 to 10 cm scale) from baseline in the potential 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).
2. Percentage of Participants Who Achieved at Least a 50 Percent (%) Improvement From Baseline in Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) at Week 24 [ Time Frame: Week 24 ]
   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), morning stiffness(MS) (2 questions: duration and severity). Each question is an easy to answer 10 cm visual analog scale (VAS), with 0 being none, and 10 being very severe and for the last question related to MS duration: 0(0 hours), 10(2 or more hours). In order to give each of 5 symptoms equal weight, mean of 2 questions about MS will be added to total of remaining 4 scores, final BASDAI score (ranging 0-10) is average of 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).
3. Change From Baseline in Bath Ankylosing Spondylitis Functional Index (BASFI) Total Score at Week 24 [ Time Frame: Baseline and Week 24 ]
   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 (consider non-responder at Week 20 and 24).
4. Percentage of Participants Who Achieved Ankylosing Spondylitis Disease Activity Score-C Reactive Protein (ASDAS-CRP) Inactive Disease (<1.3) at Week 24 [ Time Frame: Week 24 ]
   ASDAS includes CRP mg/L; four additional self-reported items (rated on 0-10cm VAS or 0-10 numerical rating scale [NRS]) included are 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*participant global) + (0.073*peripheral pain/swelling) + (0.058* duration of morning stiffness) + (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).
5. 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 ]
   Change from baseline in hsCRP 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).
6. 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 ]
   ASDAS includes CRP mg/L; four additional self-reported items (rated on 0-10cm VAS or 0-10 numerical rating scale [NRS]) included are 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*participant global) + (0.073*peripheral pain/swelling) + (0.058* duration of morning stiffness) + (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- responders).
7. Percentage of Participants Who Achieved ASAS 40 Responses at Week 4, 8, 12, 16 and 20 [ Time Frame: Week 4, 8, 12, 16 and 20 ]
   ASAS 40 defined as improvement from baseline >= 40% and with an absolute improvement from baseline of at least 2 on 0 to10cm scale in at least 3 of following 4 domains: Patient's global assessment (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).
8. Percentage of Participants Who Achieved ASAS 20 Responses at Week 4, 8, 12, 16 and 20 [ Time Frame: Week 4, 8, 12, 16 and 20 ]
   ASAS 20 defined as improvement from baseline of >= 20% and with an 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 (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); absence of deterioration (>= 20% and worsening of at least 1 on a 0 to 10 cm scale) from baseline in the potential 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).
9. 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 ]
   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), morning stiffness(MS) (2 questions: duration and severity). Each question is an easy to answer 10 cm visual analog scale (VAS), with 0 being none, and 10 being very severe and for the last question related to MS duration: 0(0 hours), 10(2 or more hours). In order to give each of 5 symptoms equal weight, mean of 2 questions about MS will be added to total of remaining 4 scores, final BASDAI score (ranging 0-10) is average of 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).
10. Change From Baseline in BASFI Total Score at Week 4, 8, 12, 16 and 20 [ Time Frame: Baseline, Week 4, 8, 12, 16 and 20 ]
    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 (consider non-responder at Week 20 and 24).

Eligibility Criteria

• Ages Eligible for Study: 18 Years and older (Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Criteria

Inclusion Criteria:

• Participants must have a diagnosis of definite ankylosing spondylitis (AS), as defined by the modified 1984 New York criteria. The radiographic criterion must be confirmed by a central xray reader and at least 1 clinical criterion must be met
• Participants must have symptoms of active disease at screening and at baseline, as evidenced by both a Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) score of greater than or equal to (>=4) and a visual analog scale (VAS) score for total back pain of >=4, each on a scale of 0 to 10
• Participants with elevated high sensitivity C-reactive protein (hsCRP) level of >=0.300 milligram per deciliter (mg/dL) at screening
• Refractory by either lack of benefit or documented intolerance to 1 and no more than 1 anti-TNF(alpha) agent
• Inadequate response to at least 2 nonsteroidal anti-inflammatory drugs (NSAIDs) over a 4-week period in total with maximal doses of NSAID(s), or is unable to receive a full 4 weeks of maximal NSAID therapy because of intolerance, toxicity, or contraindications to NSAIDs.
• Participants with complete ankylosis of the spine are permitted to be included in the study, but will be limited to approximately 10 percent (%) of the study population

Exclusion Criteria:

• Participants who have other inflammatory diseases that might confound the evaluations of benefit from the ustekinumab therapy, including but not limited to, rheumatoid arthritis, systemic lupus erythematosus, or Lyme disease
• Participants who have received infliximab or infliximab biosimilar, within 12 weeks of the first study agent administration; have received adalimumab, adalimumab biosimilar, or certolizumab pegol within 6 weeks of the first study agent administration; have received etanercept or etanercept biosimilar within 6 weeks of the first study agent administration
• Participants who have ever received golimumab
• Participants who are pregnant, nursing, or planning a pregnancy or fathering a child while enrolled in the study or within 5 months after receiving the last administration of study agent
• Participants who have received any systemic immunosuppressives or disease-modifying antirheumatic drugs (DMARDs) other than methotrexate (MTX), sulfasalazine (SSZ), or hydroxychloroquine (HCQ) within 4 weeks prior to first administration of study agent. Medications in these categories include, but are not limited to leflunomide, chloroquine, azathioprine, cyclosporine, mycophenolate mofetil, gold, and penicillamine

Contacts and Locations

Locations

United States, Arizona

Glendale, Arizona, United States

Peoria, Arizona, United States

Phoenix, Arizona, United States

United States, California

Fremont, California, United States

United States, Florida

Saint Petersburg, Florida, United States

Tampa, Florida, United States

United States, Idaho

Meridian, Idaho, United States

United States, Illinois

Chicago, Illinois, United States

United States, Louisiana

Monroe, Louisiana, United States

United States, Minnesota

Eagan, Minnesota, United States

United States, New York

Orchard Park, New York, United States

United States, Oregon

Portland, Oregon, United States

United States, Pennsylvania

Duncansville, Pennsylvania, United States

Wyomissing, Pennsylvania, United States

United States, Tennessee

Jackson, Tennessee, United States

United States, Texas

Austin, Texas, United States

Mesquite, Texas, United States

United States, Virginia

Arlington, Virginia, United States

United States, Washington

Seattle, Washington, United States

Argentina

Buenos Aires, Argentina

Ciudad de Buenos Aires, Argentina

Ciudad De La Plata, Argentina

Ciudad De San Miguel De Tucuman, Argentina

Cordoba, Argentina

Belgium

Brussel, Belgium

Bruxelles, Belgium

Genk, Belgium

Gent, Belgium

Leuven, Belgium

Liège, Belgium

Merksem (Antwerp), Belgium

Brazil

Campinas, Brazil

Curitiba, Brazil

Goiânia, Brazil

Juiz de Fora, Brazil

Porto Alegre, Brazil

Rio de Janeiro, Brazil

Santo André, Brazil

Sao Paulo, Brazil

São Paulo, Brazil

Bulgaria

Burgas, Bulgaria

Pleven, Bulgaria

Plovdiv, Bulgaria

Ruse, Bulgaria

Sofia, Bulgaria

Canada, British Columbia

Victoria, British Columbia, Canada

Canada, Newfoundland and Labrador

St. John's, Newfoundland and Labrador, Canada

Canada, Ontario

Windsor, Ontario, Canada

Canada

Quebec, Canada

Toronto, Canada

Czechia

Bruntal, Czechia

Pardubice, Czechia

Prague 5, Czechia

Praha 2, Czechia

Praha 4, Czechia

Uherske Hradiste, Czechia

Zlin, Czechia

France

Boulogne-Billancourt, France

Chambray Les Tours, France

Echirolles, France

Montpellier, Herault, France

Orleans, France

Paris, France

Rouen, France

Toulouse, France

Germany

Bad Neuheim, Germany

Berlin, Germany

Gommern, Germany

Hamburg, Germany

Herne, Germany

Koeln, Germany

Olsberg, Germany

Ratingen, Germany

Hungary

Budapest, Hungary

Debrecen, Hungary

Eger, Hungary

Kistarcsa, Hungary

Nyíregyháza, Hungary

Szolnok, Hungary

Székesfehérvár, Hungary

Veszprem, Hungary

Korea, Republic of

Daegu, Korea, Republic of

Daejeon, Korea, Republic of

Gwangju, Korea, Republic of

JeonJu, Korea, Republic of

Seoul, Korea, Republic of

Suwon, Korea, Republic of

Mexico

Culiacan, Mexico

Guadalajara, Mexico

Mexico City, Mexico

Poland

Białystok, Poland

Bydgoszcz, Poland

Elblag, Poland

Nadarzyn, Poland

Szczecin, Poland

Torun, Poland

Warszawa, Poland

Portugal

Almada, Portugal

Lisboa, Portugal

Porto, Portugal

Russian Federation

Belgorod, Russian Federation

Chelyabinsk, Russian Federation

Chita, Russian Federation

Kazan, Russian Federation

Kemerovo, Russian Federation

Khanty-Mansiysk, Russian Federation

Kursk, Russian Federation

Moscow, Russian Federation

Nizhniy Novgorod, Russian Federation

Omsk, Russian Federation

Orenburg, Russian Federation

Petrozavodsk, Russian Federation

Pyatigorsk, Russian Federation

Saratov, Russian Federation

St. Petersburg, Russian Federation

St.Petersburg, Russian Federation

Ufa, Russian Federation

Zelenograd, Russian Federation

Spain

A Coruna, Spain

Barcelona, Spain

Bilbao, Spain

Córdoba, Spain

L´Hospitalet de Llobregat, Spain

Madrid, Spain

Málaga, Spain

Sabadell, Spain

Santiago de Compostela, Spain

Sevilla, Spain

Valencia, Spain

Taiwan

Changhua, Taiwan

Hualien, Taiwan

Kaohsiung, Taiwan

Taichung, Taiwan

Tainan, Taiwan

Taipei, Taiwan

Taoyuan, Taiwan

Ukraine

Cherkasy, Ukraine

Ivano-Frankivsk, Ukraine

Kharkiv, Ukraine

Kyiv, Ukraine

Lviv, Ukraine

Odessa, Ukraine

Poltava, Ukraine

Ternopil, Ukraine

Uzhgorod, Ukraine

Vinnytsya, Ukraine

Zaporizhzhya, Ukraine

United Kingdom

Bath, United Kingdom

Leytonstone, United Kingdom

London, United Kingdom

Peterborough, United Kingdom

Stoke on Trent, United Kingdom

Upton, United Kingdom

Sponsors and Collaborators

Janssen Research & Development, LLC

Investigators

• Study Director: Janssen Research & Development, LLC Clinical Trial; Janssen Research & Development, LLC

  Study Documents (Full-Text)

Documents provided by Janssen Research & Development, LLC:

Statistical Analysis Plan  [PDF] April 14, 2017

Study Protocol  [PDF] July 13, 2015

More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Deodhar A, Gensler LS, Sieper J, Clark M, Calderon C, Wang Y, Zhou Y, Leu JH, Campbell K, Sweet K, Harrison DD, Hsia EC, van der Heijde D. Three Multicenter, Randomized, Double-Blind, Placebo-Controlled Studies Evaluating the Efficacy and Safety of Ustekinumab in Axial Spondyloarthritis. Arthritis Rheumatol. 2019 Feb;71(2):258-270. doi: 10.1002/art.40728. Epub 2018 Dec 29.

• Responsible Party: Janssen Research & Development, LLC
• ClinicalTrials.gov Identifier: NCT02438787
• Other Study ID Numbers: CR107099; CNTO1275AKS3002 ( Other Identifier: Janssen Research & Development, LLC ); 2015-000288-16 ( EudraCT Number )
• First Posted: May 8, 2015
• Results First Posted: October 1, 2018
• Last Update Posted: August 28, 2019
• Last Verified: August 2019

• Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Janssen Research & Development, LLC:

Ankylosing Spondylitis; Ustekinumab; Golimumab; STELARA

Additional relevant MeSH terms:

Spondylitis; Spondylarthritis; Bone Diseases, Infectious; Infections; Bone Diseases; Musculoskeletal Diseases; Spinal Diseases; Arthritis; Joint Diseases; Golimumab; Ustekinumab; Dermatologic Agents; Tumor Necrosis Factor Inhibitors; Anti-Inflammatory Agents; Immunosuppressive Agents; Immunologic Factors; Physiological Effects of Drugs