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Effect of Secukinumab on Radiographic Progression in Ankylosing Spondylitis as Compared to GP2017 (Adalimumab Biosimilar) (SURPASS)

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ClinicalTrials.gov Identifier: NCT03259074
Recruitment Status : Recruiting
First Posted : August 23, 2017
Last Update Posted : October 8, 2019
Sponsor:
Information provided by (Responsible Party):
Novartis ( Novartis Pharmaceuticals )

Brief Summary:
The purpose of this study is to demonstrate the impact of secukinumab on progression of structural damage in the spine, as measured by the mSASSS in patients with AS.

Condition or disease Intervention/treatment Phase
Ankylosing Spondylitis Biological: Secukinumab Biological: GP2017 (adalimumab biosimilar) Phase 3

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 837 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Masking Description: The Participant, Care Provider, Investigator and Sponsor are blinded to Secukinumab dose
Primary Purpose: Treatment
Official Title: A Randomized, Partially-blinded Study of Secukinumab to Demonstrate Reduction of Radiographic Progression Versus GP2017 (Adalimumab Biosimilar) at 104 Weeks and to Assess the Long Term Safety, Tolerability and Efficacy up to 2 Years in Patients With Active Ankylosing Spondylitis
Actual Study Start Date : October 24, 2017
Estimated Primary Completion Date : September 2, 2021
Estimated Study Completion Date : December 23, 2021


Arm Intervention/treatment
Experimental: Secukinumab 150 mg s.c.
Secukinumab 150 mg will be administered at Baseline, Weeks 1, 2, 3 and 4, followed by dosing every 4 weeks until Week 100
Biological: Secukinumab
Eligible subjects are randomized to one of three treatment arms in a 1:1:1 ratio

Experimental: Secukinumab 300 mg s.c.
Secukinumab 300 mg will be administered at Baseline, Weeks 1, 2, 3 and 4, followed by dosing every 4 weeks until Week 100
Biological: Secukinumab
Eligible subjects are randomized to one of three treatment arms in a 1:1:1 ratio

Experimental: GP2017 (adalimumab biosimilar) 40mg s.c.
GP2017 (adalimumab biosimilar) 40 mg will be administered at Baseline followed by dosing every 2 weeks until Week 102
Biological: GP2017 (adalimumab biosimilar)
Eligible subjects are randomized to one of three treatment arms in a 1:1:1 ratio




Primary Outcome Measures :
  1. No radiographic progression as measured by modified Stoke Ankylosing Spondylitis Spine Score (mSASSS) [ Time Frame: 104 weeks ]
    To demonstrate the proportion of subjects on secukinumab (150 mg s.c. or 300 mg s.c.) with no radiographic progression as measured by mSASSS at Week 104 is superior to subjects on GP2017 (adalimumab biosimilar 40 mg s.c.)


Secondary Outcome Measures :
  1. Change from baseline in modified Stoke Ankylosing Spondylitis Spine Score (mSASSS) [ Time Frame: 104 weeks ]
    To demonstrate the change from baseline in mSASSS in subjects on secukinumab (150 mg s.c. or 300 mg s.c.) is superior to GP2017 (adalimumab biosimilar 40 mg s.c.) at Week 104

  2. No new syndesmophytes as measured by mSASSS [ Time Frame: 104 weeks ]
    The proportion of subjects with no new syndesmophytes is defined as the number of patients with a syndesmophyte at baseline who develops one by week 104, as measured by mSASSS

  3. Assessment of SpondyloArthritis International Society 20 (ASAS20) [ Time Frame: 104 weeks ]
    ASAS20 response is defined as an improvement of ≥20% and ≥1 unit on a scale of 10 in at least three of the four ASAS main domains and no worsening of ≥20% and ≥1 unit in the remaining domain

  4. ASAS40 [ Time Frame: 104 weeks ]
    ASAS40 response is defined as an improvement of ≥40% and ≥2 units on a scale of 10 in at least three of the four ASAS main domains and no worsening at all in the remaining domain

  5. ASAS partial remission [ Time Frame: 104 weeks ]
    ASAS partial remission is defined as a value not above 2 units in each of four main domains on a scale of 0 to 10

  6. Ankylosing Spondylitis Disease Activity Score (ASDAS) inactive disease [ Time Frame: 104 weeks ]
    An ASDAS inactive disease response is a score of <1.3 on a composite index to assess disease activity in Ankylosing Spondylitis. Parameters include spinal pain, the patient's global assessment of disease activity, peripheral pain/swelling, duration of morning stiffness and C-reactive protein (CRP) in mg/L.

  7. Berlin sacroiliac (SI) joint edema score [ Time Frame: 104 weeks ]
    To evaluate the Berlin SI joint edema score in subjects on secukinumab (150 mg s.c. or 300 mg s.c.) at Week 104 versus GP2017 (adalimumab biosimilar 40 mg s.c.)

  8. Ankylosing Spondylitis Spine Magnetic Resonance Imaging - activity (ASspiMRI-a) Berlin modification score [ Time Frame: 104 weeks ]
    To evaluate the ASspiMRI-a Berlin modification score in subjects on secukinumab (150 mg s.c. or 300 mg s.c.) at Week 104 versus GP2017 (adalimumab biosimilar 40 mg s.c.)



Information from the National Library of Medicine

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

Inclusion Criteria:

  • Male or non-pregnant, non-nursing female patients at least 18 years of age
  • Diagnosis of moderate to severe Ankylosing Spondylitis with radiologic evidence (centrally read X-ray) fulfilling the Modified New York criteria for AS despite previous or current NSAID/ nonbiologic DMARD therapy
  • Active AS assessed by total BASDAI ≥ 4 on a scale of 0-10
  • Spinal pain as measured by BASDAI question #2 ≥ 4 (0-10)
  • Total back pain as measured by visual analog scale (VAS) ≥ 40 mm (0-100 mm)
  • hsCRP ≥ 5 mg/L OR presence of at least 1 syndesmophyte on centrally read spinal X-ray

Exclusion Criteria:

  • Patients with total ankylosis of the spine
  • Pregnant or nursing (lactating) women
  • Evidence of ongoing infectious or malignant process
  • Previous exposure to any biologic immunomodulating agent, including those targeting IL-17, IL-17 receptor or TNFα
  • Subjects taking high potency opioid analgesics
  • Previous treatment with any cell-depleting therapies including but not limited to anti-CD20, investigational agents

Other protocol-defined inclusion/exclusion criteria may apply


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03259074


Contacts
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Contact: Novartis Pharmaceuticals 1-888-669-6682 novartis.email@novartis.com
Contact: Novartis Pharmaceuticals +41613241111

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Locations
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United States, Arizona
Novartis Investigative Site Active, not recruiting
Mesa, Arizona, United States, 85202
Novartis Investigative Site Recruiting
Paradise Valley, Arizona, United States, 85253
United States, California
Novartis Investigative Site Active, not recruiting
Escondido, California, United States, 92025
Novartis Investigative Site Active, not recruiting
La Mesa, California, United States, 91942
Novartis Investigative Site Active, not recruiting
San Francisco, California, United States, 94143 0138
United States, Colorado
Novartis Investigative Site Recruiting
Greenwood Village, Colorado, United States, 80111
United States, Connecticut
Novartis Investigative Site Completed
Stamford, Connecticut, United States, 06905
Novartis Investigative Site Recruiting
Trumbull, Connecticut, United States, 06611
United States, Florida
Novartis Investigative Site Recruiting
Cutler Bay, Florida, United States, 33157
Novartis Investigative Site Active, not recruiting
Gainesville, Florida, United States, 32607
Novartis Investigative Site Active, not recruiting
Tampa, Florida, United States, 33609
United States, Georgia
Novartis Investigative Site Recruiting
Atlanta, Georgia, United States, 30342
United States, Idaho
Novartis Investigative Site Recruiting
Boise, Idaho, United States, 83702
Novartis Investigative Site Recruiting
Idaho Falls, Idaho, United States, 83404
United States, Illinois
Novartis Investigative Site Recruiting
Peoria, Illinois, United States, 61602
United States, Louisiana
Novartis Investigative Site Completed
Baton Rouge, Louisiana, United States, 70809
Novartis Investigative Site Active, not recruiting
Shreveport, Louisiana, United States, 71101
United States, Maryland
Novartis Investigative Site Completed
Hagerstown, Maryland, United States, 21740
Novartis Investigative Site Active, not recruiting
Wheaton, Maryland, United States, 20902
United States, Massachusetts
Novartis Investigative Site Recruiting
Boston, Massachusetts, United States, 02115
United States, Minnesota
Novartis Investigative Site Completed
Eagan, Minnesota, United States, 55121
United States, Montana
Novartis Investigative Site Active, not recruiting
Great Falls, Montana, United States, 59405
Novartis Investigative Site Completed
Great Falls, Montana, United States, 59405
United States, Nebraska
Novartis Investigative Site Active, not recruiting
Lincoln, Nebraska, United States, 68516
United States, New Jersey
Novartis Investigative Site Recruiting
Somerset, New Jersey, United States, 08873
United States, New York
Novartis Investigative Site Recruiting
Brooklyn, New York, United States, 11221
Novartis Investigative Site Recruiting
Jackson Heights, New York, United States, 11372
Novartis Investigative Site Recruiting
Yonkers, New York, United States, 10701
United States, North Carolina
Novartis Investigative Site Active, not recruiting
Greensboro, North Carolina, United States, 27408
United States, Ohio
Novartis Investigative Site Active, not recruiting
Dayton, Ohio, United States, 45402
Novartis Investigative Site Active, not recruiting
Middleburg Heights, Ohio, United States, 44130
Novartis Investigative Site Recruiting
Perrysburg, Ohio, United States, 43551
United States, Oregon
Novartis Investigative Site Active, not recruiting
Portland, Oregon, United States, 97239
United States, Pennsylvania
Novartis Investigative Site Active, not recruiting
Duncansville, Pennsylvania, United States, 16635
United States, Tennessee
Novartis Investigative Site Active, not recruiting
Memphis, Tennessee, United States, 38119
Novartis Investigative Site Recruiting
Nashville, Tennessee, United States, 37116
United States, Texas
Novartis Investigative Site Completed
Carrollton, Texas, United States, 75010
Novartis Investigative Site Active, not recruiting
Mesquite, Texas, United States, 75150
United States, Washington
Novartis Investigative Site Active, not recruiting
Kennewick, Washington, United States, 99336
Novartis Investigative Site Recruiting
Seattle, Washington, United States, 98122
United States, Wisconsin
Novartis Investigative Site Completed
Franklin, Wisconsin, United States, 53132
Argentina
Novartis Investigative Site Recruiting
Ciudad Autonoma de Bs As, Argentina, C1428AZF
Australia, Victoria
Novartis Investigative Site Active, not recruiting
Malvern East, Victoria, Australia, 3145
Belgium
Novartis Investigative Site Recruiting
Bruxelles, Belgium, 1070
Novartis Investigative Site Recruiting
Genk, Belgium, 3600
Canada, Manitoba
Novartis Investigative Site Active, not recruiting
Winnipeg, Manitoba, Canada, R3A 1M1
Canada, Ontario
Novartis Investigative Site Active, not recruiting
Barrie, Ontario, Canada, L4M 6L2
Canada, Quebec
Novartis Investigative Site Active, not recruiting
Sainte-Foy, Quebec, Canada, G1V 3M7
Novartis Investigative Site Active, not recruiting
Trois Rivieres, Quebec, Canada, G8Z 1Y2
Chile
Novartis Investigative Site Recruiting
Santiago, RM, Chile, 7500588
Novartis Investigative Site Recruiting
Concepcion, Chile
Novartis Investigative Site Active, not recruiting
Santiago, Chile, 8207257
Novartis Investigative Site Completed
Santiago, Chile, 8880465
Novartis Investigative Site Active, not recruiting
Santiago, Chile
Colombia
Novartis Investigative Site Active, not recruiting
Bucaramanga, Santander, Colombia, 0001
Novartis Investigative Site Active, not recruiting
Barranquilla, Colombia
Czechia
Novartis Investigative Site Recruiting
Brno-Zidonice, CZE, Czechia, 61500
Novartis Investigative Site Recruiting
Brno, Czechia, 63800
Novartis Investigative Site Recruiting
Praha 11, Czechia, 148 00
Novartis Investigative Site Recruiting
Praha 2, Czechia, 128 50
Novartis Investigative Site Recruiting
Uherske Hradiste, Czechia, 686 01
Denmark
Novartis Investigative Site Active, not recruiting
Aalborg, Denmark, DK 9000
Novartis Investigative Site Active, not recruiting
Copenhagen, Denmark, 2100
Finland
Novartis Investigative Site Recruiting
Joensuu, Finland, 80210
Novartis Investigative Site Recruiting
Lappeenranta, Finland, 53130
France
Novartis Investigative Site Active, not recruiting
Nice, Cedex1, France, 06001
Novartis Investigative Site Active, not recruiting
Boulogne Billancourt, France, 92104
Novartis Investigative Site Active, not recruiting
Le Mans, France, 72037
Novartis Investigative Site Active, not recruiting
Paris Cedex 14, France, 75679
Novartis Investigative Site Active, not recruiting
Paris, France, 75012
Novartis Investigative Site Active, not recruiting
Toulouse, France, 31059
Germany
Novartis Investigative Site Active, not recruiting
Bad Doberan, Germany, 18209
Novartis Investigative Site Recruiting
Bayreuth, Germany, 95444
Novartis Investigative Site Terminated
Berlin, Germany, 12163
Novartis Investigative Site Active, not recruiting
Berlin, Germany, 12163
Novartis Investigative Site Active, not recruiting
Berlin, Germany, 13125
Novartis Investigative Site Active, not recruiting
Berlin, Germany, 13353
Novartis Investigative Site Active, not recruiting
Berlin, Germany, 14059
Novartis Investigative Site Active, not recruiting
Chemnitz, Germany, 09130
Novartis Investigative Site Active, not recruiting
Erlangen, Germany, 91056
Novartis Investigative Site Active, not recruiting
Gottingen, Germany, 37075
Novartis Investigative Site Active, not recruiting
Hamburg, Germany, 20095
Novartis Investigative Site Active, not recruiting
Hamburg, Germany, 22415
Novartis Investigative Site Active, not recruiting
Herne, Germany, 44649
Novartis Investigative Site Active, not recruiting
Magdeburg, Germany, 39110
Novartis Investigative Site Active, not recruiting
Planegg, Germany, 82152
Novartis Investigative Site Active, not recruiting
Ratingen, Germany, 40878
Greece
Novartis Investigative Site Recruiting
Thessaloniki, GR, Greece, 564 29
Novartis Investigative Site Recruiting
Athens, Greece, 115 27
Novartis Investigative Site Recruiting
Athens, Greece, 145 61
Israel
Novartis Investigative Site Recruiting
Haifa, Israel, 3339419
Novartis Investigative Site Recruiting
Haifa, Israel, 3525408
Novartis Investigative Site Recruiting
Kfar Saba, Israel, 4428164
Novartis Investigative Site Recruiting
Tel Aviv, Israel, 6423906
Japan
Novartis Investigative Site Active, not recruiting
Nishinomiya, Hyogo, Japan, 663 8501
Novartis Investigative Site Active, not recruiting
Kita-gun, Kagawa, Japan, 761-0793
Novartis Investigative Site Active, not recruiting
Nankoku city, Kochi, Japan, 783 8505
Novartis Investigative Site Active, not recruiting
Tenri, Nara, Japan, 632-8552
Novartis Investigative Site Completed
Kawachinagano, Osaka, Japan, 586-8521
Novartis Investigative Site Active, not recruiting
Bunkyo ku, Tokyo, Japan, 113-8431
Novartis Investigative Site Active, not recruiting
Chuo ku, Tokyo, Japan, 104-8560
Novartis Investigative Site Active, not recruiting
Meguro, Tokyo, Japan, 153-8515
Novartis Investigative Site Withdrawn
Shinjuku ku, Tokyo, Japan, 162 8666
Novartis Investigative Site Active, not recruiting
Shinjuku-ku, Tokyo, Japan, 160 8582
Korea, Republic of
Novartis Investigative Site Active, not recruiting
Seoul, Seocho Gu, Korea, Republic of, 06591
Novartis Investigative Site Active, not recruiting
Gwangju, Korea, Republic of, 61469
Novartis Investigative Site Active, not recruiting
Seoul, Korea, Republic of, 03080
Novartis Investigative Site Active, not recruiting
Seoul, Korea, Republic of, 04763
Novartis Investigative Site Active, not recruiting
Seoul, Korea, Republic of, 05278
Novartis Investigative Site Active, not recruiting
Seoul, Korea, Republic of, 06273
Mexico
Novartis Investigative Site Recruiting
Mexicali, Baja California, Mexico, 21100
Novartis Investigative Site Active, not recruiting
Torreon, Coahulia, Mexico, 27000
Novartis Investigative Site Active, not recruiting
Culiacan, MEX, Mexico, 80000
Novartis Investigative Site Recruiting
Monterrey, Nuevo Leon, Mexico, 64460
Novartis Investigative Site Active, not recruiting
San Luis potosi, Mexico, 78213
Monaco
Novartis Investigative Site Active, not recruiting
Monaco, Monaco, 98000
Netherlands
Novartis Investigative Site Active, not recruiting
Amsterdam, Netherlands, 1105 AZ
Novartis Investigative Site Completed
Enschede, Netherlands, 7512KZ
Novartis Investigative Site Active, not recruiting
Leeuwarden, Netherlands, 8934 AD
Novartis Investigative Site Active, not recruiting
Leiden, Netherlands, 2333 ZA
Novartis Investigative Site Active, not recruiting
Maastricht, Netherlands, 6229 HX
Novartis Investigative Site Active, not recruiting
Rotterdam, Netherlands, 3079 DZ
Peru
Novartis Investigative Site Active, not recruiting
Jesus Maria, Lima, Peru, 11
Novartis Investigative Site Active, not recruiting
San Isidro, Lima, Peru, 27
Novartis Investigative Site Active, not recruiting
Santiago de Surco, Lima, Peru, 33
Novartis Investigative Site Active, not recruiting
Lima, Peru, 1
Philippines
Novartis Investigative Site Recruiting
Manila, Philippines, 1008
Novartis Investigative Site Recruiting
Quezon City, Philippines, 1102
Novartis Investigative Site Recruiting
Quezon City, Philippines, 1118
Poland
Novartis Investigative Site Recruiting
Bydgoszcz, Poland, 85 168
Novartis Investigative Site Recruiting
Dopiewo, Poland, 62 069
Novartis Investigative Site Recruiting
Krakow, Poland, 30 002
Novartis Investigative Site Recruiting
Poznan, Poland, 61 113
Novartis Investigative Site Recruiting
Sopot, Poland, 81 756
Portugal
Novartis Investigative Site Active, not recruiting
Almada, Portugal, 2801 951
Novartis Investigative Site Active, not recruiting
Lisboa, Portugal, 1050-034
Novartis Investigative Site Active, not recruiting
Lisboa, Portugal, 1349 019
Novartis Investigative Site Active, not recruiting
Ponte de Lima, Portugal, 4990 041
Novartis Investigative Site Active, not recruiting
Porto, Portugal, 4200 319
Novartis Investigative Site Active, not recruiting
Vila Nova de Gaia, Portugal, 4434 502
Romania
Novartis Investigative Site Recruiting
Bacau, Romania, 600114
Novartis Investigative Site Active, not recruiting
Bucharest, Romania, 030167
Novartis Investigative Site Active, not recruiting
Bucuresti, Romania, 011172
Novartis Investigative Site Active, not recruiting
Cluj Napoca, Romania, 400006
Russian Federation
Novartis Investigative Site Active, not recruiting
Barnaul, Russian Federation, 656050
Novartis Investigative Site Active, not recruiting
Chelyabinsk, Russian Federation, 454076
Novartis Investigative Site Active, not recruiting
Ekaterinburg, Russian Federation, 620137
Novartis Investigative Site Active, not recruiting
Ivanovo, Russian Federation, 153005
Novartis Investigative Site Active, not recruiting
Kazan, Russian Federation, 420064
Novartis Investigative Site Active, not recruiting
Kemerovo, Russian Federation, 650029
Novartis Investigative Site Active, not recruiting
Kemerovo, Russian Federation, 650066
Novartis Investigative Site Active, not recruiting
Moscow, Russian Federation, 115522
Novartis Investigative Site Active, not recruiting
Moscow, Russian Federation, 129110
Novartis Investigative Site Active, not recruiting
Petrozavodsk, Russian Federation, 185019
Novartis Investigative Site Active, not recruiting
Saint Petersburg, Russian Federation, 197022
Novartis Investigative Site Active, not recruiting
Saint Petersburg, Russian Federation, 197341
Novartis Investigative Site Active, not recruiting
St Petersburg, Russian Federation, 190068
Novartis Investigative Site Active, not recruiting
Ufa, Russian Federation, 450005
Novartis Investigative Site Active, not recruiting
Yaroslavl, Russian Federation, 150003
Slovakia
Novartis Investigative Site Active, not recruiting
Bratislava, Slovak Republic, Slovakia, 813 69
Novartis Investigative Site Active, not recruiting
Piestany, SVK, Slovakia, 921 12
Novartis Investigative Site Active, not recruiting
Bratislava, Slovakia, 85101
Novartis Investigative Site Active, not recruiting
Kosice, Slovakia, 04011
Novartis Investigative Site Recruiting
Sabinov, Slovakia, 08301
Novartis Investigative Site Active, not recruiting
Stara Lubovna, Slovakia, 06401
Spain
Novartis Investigative Site Active, not recruiting
Villajoyosa, Alicante, Spain, 703570
Novartis Investigative Site Active, not recruiting
Badalona, Barcelona, Spain, 08916
Novartis Investigative Site Completed
Hospitalet de Llobregat, Barcelona, Spain, 08907
Novartis Investigative Site Active, not recruiting
San Vicente De Barakaldo, Bizkaia, Spain, 48903
Novartis Investigative Site Active, not recruiting
Santander, Cantabria, Spain, 39008
Novartis Investigative Site Active, not recruiting
La Coruna, Galicia, Spain, 15006
Novartis Investigative Site Active, not recruiting
Bilbao, Pais Vasco, Spain, 48013
Novartis Investigative Site Recruiting
Vigo, Pontevedra, Spain, 36200
Novartis Investigative Site Active, not recruiting
Vitoria, Vitoria Gasteiz, Spain, 01009
Novartis Investigative Site Active, not recruiting
Barcelona, Spain, 08003
Novartis Investigative Site Active, not recruiting
Madrid, Spain, 28034
Novartis Investigative Site Active, not recruiting
Madrid, Spain, 28041
Novartis Investigative Site Recruiting
Madrid, Spain, 28050
Novartis Investigative Site Active, not recruiting
Madrid, Spain, 28942
Novartis Investigative Site Active, not recruiting
Santiago de Compostela, Spain, 15706
Novartis Investigative Site Active, not recruiting
Valencia, Spain, 46009
Taiwan
Novartis Investigative Site Active, not recruiting
Taichung, Taiwan ROC, Taiwan, 40201
Novartis Investigative Site Active, not recruiting
Dalin, Taiwan, 622
Novartis Investigative Site Active, not recruiting
Kaohsiung, Taiwan, 80756
Novartis Investigative Site Active, not recruiting
Kaohsiung, Taiwan, 81346
Novartis Investigative Site Active, not recruiting
Taipei, Taiwan, 10048
Turkey
Novartis Investigative Site Active, not recruiting
Istanbul, TUR, Turkey, 34098
Novartis Investigative Site Recruiting
Ankara, Turkey, 06230
Novartis Investigative Site Recruiting
Ankara, Turkey, 06560
Novartis Investigative Site Recruiting
Eskisehir, Turkey, 26040
Novartis Investigative Site Active, not recruiting
Izmir, Turkey, 35340
Novartis Investigative Site Active, not recruiting
Kocaeli, Turkey, 41380
United Kingdom
Novartis Investigative Site Active, not recruiting
Christchurch, Dorset, United Kingdom, BH23 2JX
Novartis Investigative Site Active, not recruiting
London, Edmonton, United Kingdom, N18 1QX
Novartis Investigative Site Active, not recruiting
London, GBR, United Kingdom, SW10 9NH
Novartis Investigative Site Terminated
Maidstone, Kent, United Kingdom, ME16 9QQ
Novartis Investigative Site Active, not recruiting
Leytonstone, London, United Kingdom, E11 1NR
Novartis Investigative Site Active, not recruiting
Stoke on Trent, Staffordshire, United Kingdom, ST6 7AG
Novartis Investigative Site Active, not recruiting
Bath, United Kingdom, BA1 1RL
Novartis Investigative Site Active, not recruiting
Bristol, United Kingdom, BS1 3NU
Novartis Investigative Site Active, not recruiting
Leicester, United Kingdom, LE1 5WW
Novartis Investigative Site Active, not recruiting
Liverpool, United Kingdom, L9 7AL
Novartis Investigative Site Active, not recruiting
London, United Kingdom, NW3 2QG
Novartis Investigative Site Active, not recruiting
Manchester, United Kingdom, M23 9LT
Novartis Investigative Site Active, not recruiting
Norwich, United Kingdom, NR4 7UY
Novartis Investigative Site Active, not recruiting
Portsmouth, United Kingdom, PO6 3LY
Novartis Investigative Site Active, not recruiting
Torquay, United Kingdom, TQ2 7AA
Novartis Investigative Site Active, not recruiting
Wolverhampton, United Kingdom, WV10 0QP
Sponsors and Collaborators
Novartis Pharmaceuticals

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Responsible Party: Novartis Pharmaceuticals
ClinicalTrials.gov Identifier: NCT03259074     History of Changes
Other Study ID Numbers: CAIN457K2340
First Posted: August 23, 2017    Key Record Dates
Last Update Posted: October 8, 2019
Last Verified: October 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
Plan Description:

Novartis is committed to sharing with qualified external researchers, access to patient-level data and supporting clinical documents from eligible studies. These requests are reviewed and approved by an independent review panel on the basis of scientific merit. All data provided is anonymized to respect the privacy of patients who have participated in the trial in line with applicable laws and regulations.

This trial data availability is according to the criteria and process described on www.clinicalstudydatarequest.com


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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Novartis ( Novartis Pharmaceuticals ):
ankylosing spondylitis, AS, secukinumab, GP2017, adalimumab biosimilar, mSASSS, ASAS20
Additional relevant MeSH terms:
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Spondylitis
Spondylitis, Ankylosing
Bone Diseases, Infectious
Infection
Bone Diseases
Musculoskeletal Diseases
Spinal Diseases
Spondylarthropathies
Spondylarthritis
Ankylosis
Joint Diseases
Arthritis
Adalimumab
Antibodies, Monoclonal
Anti-Inflammatory Agents
Antirheumatic Agents
Immunologic Factors
Physiological Effects of Drugs