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Trial record 43 of 298 for:    "Ankylosing spondylitis"

A Randomized, Double-blind, Placebo-controlled Multicenter Study of Secukinumab (AIN457) to Examine the Clinical Efficacy and the Nonsteroidal Anti-inflammatory Drug (NSAID)-Sparing Effect of Secukinumab Over 16 Weeks in Patients With Ankylosing Spondylitis (ASTRUM)

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ClinicalTrials.gov Identifier: NCT02763046
Recruitment Status : Active, not recruiting
First Posted : May 5, 2016
Last Update Posted : June 11, 2019
Sponsor:
Information provided by (Responsible Party):
Novartis ( Novartis Pharmaceuticals )

Brief Summary:
The current study will assess the clinical Assessment of SpondyloArthritis international Society (ASAS) 20 response to Secukinumab and evaluate to which extent concomitant nonsteroidal anti-inflammatory drug (NSAID) treatment can be reduced in patients treated with Secukinumab or placebo following an initial run-in phase of stable NSAID therapy. In case of a positive outcome concerning the NSAID reduction this study could trigger the development of a guidance concerning NSAID reduction applicable for all Ankylosing Spondylitis (AS) patients starting a biologic treatment.

Condition or disease Intervention/treatment Phase
Ankylosing Spondylitis Biological: AIN457/Secukinumab Drug: AIN457/Secukinumab Placebo; Biological: AIN457/Secukinumab Phase 4

Detailed Description:

The current study will assess the clinical Assessment of SpondyloArthritis international Society (ASAS) 20 response to Secukinumab and evaluate to which extent concomitant nonsteroidal anti-inflammatory drug (NSAID) treatment can be reduced between Week 4 and Week 12 in patients treated with Secukinumab 150 mg or placebo following an initial run-in phase of 4 weeks on stable NSAID therapy. Two different time points of NSAID tapering initiation will be evaluated in this study:

  1. a delayed tapering approach in which NSAID will be tapered following 4 weeks of Secukinumab treatment at stable NSAID therapy.
  2. an early tapering approach in which NSAID will be tapered immediately after initiation of Secukinumab treatment.

These two approaches will be evaluated compared to placebo in order to assess whether the early or delayed NSAID tapering is superior to placebo in terms of clinical ASAS20 response and extent of reduction in NSAID intake.

As a patient-reported outcome, pain is a major patient-relevant efficacy parameter in clinical practice in Ankylosing Spondylitis (AS). This study will therefore monitor overall neck, back and hip pain on a continuous basis. It will be recommended that NSAID should be tapered if the patient reports an improvement in back pain or a level below a certain threshold. It is anticipated that the results of this study may provide guidance for the systematic adjustment of concomitant NSAID treatment in AS patients based on their initial response to Secukinumab, thereby leading to optimization of the therapeutic strategy with Secukinumab.


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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 211 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
Official Title: A Randomized, Double-blind, Placebo-controlled Multicenter Study of Secukinumab (AIN457) to Examine the Clinical Efficacy and the NSAID-sparing Effect of Secukinumab Over 16 Weeks in Patients With Ankylosing Spondylitis (ASTRUM)
Actual Study Start Date : May 31, 2016
Estimated Primary Completion Date : July 1, 2019
Estimated Study Completion Date : July 1, 2019

Resource links provided by the National Library of Medicine

Drug Information available for: Secukinumab

Arm Intervention/treatment
Experimental: AIN457/Secukinumab - delayed tapering
Secukinumab 150 mg s.c. at baseline, weeks 1, 2, 3, followed by dosing every four weeks starting at week 4 until week 20 with placebo injections at weeks at week 5, 6, 7, 17, 18 and 19. NSAID tapering allowed from week 4 (delayed tapering)
Biological: AIN457/Secukinumab
Induction: 4x 150 mg Secukinumab s.c. weekly Maintenance: 150 mg Secukinumab s.c. every 4 weeks

Experimental: AIN457/Secukinumab - early tapering
Secukinumab 150 mg s.c. at weeks 4, 5, 6 and 7, followed by dosing every four weeks starting at week 8 until week 20 with placebo injections at baseline, weeks 1, 2, 3, 17, 18 and 19. NSAID tapering allowed from week 4 (early tapering)
Biological: AIN457/Secukinumab
Induction: 4x 150 mg Secukinumab s.c. weekly Maintenance: 150 mg Secukinumab s.c. every 4 weeks

Placebo Comparator: AIN457/Secukinumab Placebo
Secukinumab Placebo s.c. at baseline, weeks 1, 2, 3, 4, 5, 6, 7, 8 and 12, followed by dosing with Secukinumab 150 mg s.c. at weeks 16, 17, 18, 19 and 20. NSAID tapering allowed from week 4.
Drug: AIN457/Secukinumab Placebo; Biological: AIN457/Secukinumab
Induction: 4x Secukinumab Placebo s.c. weekly Maintenance: Secukinumab Placebo s.c. every 4 weeks until Week 16 followed by 150 mg Secukinumab s.c. weekly for 4 weeks




Primary Outcome Measures :
  1. Proportion of patients achieving an ASAS20 response [ Time Frame: Week 12 ]
    To demonstrate that the efficacy of Secukinumab 150 mg s.c. (Secukinumab from week 0 with NSAID tapering allowed from week 4; delayed tapering) at Week 12 is superior to placebo based on the proportion of patients achieving an ASAS20 response.


Secondary Outcome Measures :
  1. Proportion of patients achieving an ASAS20 response [ Time Frame: Week 16 ]
    To demonstrate that the efficacy of Secukinumab 150 mg s.c. (Secukinumab from week 4 with NSAID tapering allowed from week 4; early tapering) at Week 16 is superior to placebo based on the proportion of patients achieving an ASAS20 response.

  2. Change from baseline in ASAS-NSAID score [ Time Frame: Week 12 ]
    To demonstrate that the change from baseline in ASAS-NSAID score at Week 12 is superior for Secukinumab 150 mg s.c. (Secukinumab from week 0 with NSAID tapering allowed from week 4; delayed tapering) as compared to placebo.

  3. Change from baseline in ASAS-NSAID score [ Time Frame: Week 12 ]
    To demonstrate that the change from baseline in ASAS-NSAID score at Week 12 is superior for Secukinumab 150 mg s.c . (Secukinumab from week 4 with NSAID tapering allowed from week 4; early tapering) as compared to placebo.

  4. Change from baseline in the total BASDAI [ Time Frame: Week 12 ]
    To demonstrate that the efficacy of Secukinumab 150 mg s.c. (Secukinumab from week 0 with NSAID tapering allowed from week 4; delayed tapering) at Week 12 is superior to placebo based on the change from baseline in the total BASDAI.

  5. Change from baseline in the total BASDAI [ Time Frame: Week 16 ]
    To demonstrate that the efficacy of Secukinumab 150 mg s.c. (Secukinumab from week 4 with NSAID tapering allowed from week 4; early tapering) at Week 16 is superior to placebo based on the change from baseline in the total BASDAI.

  6. Change from baseline in health-related Quality of Life as measured by the SF-36 Physical Component Score (PCS) [ Time Frame: Week 12 ]
    To demonstrate that the efficacy of Secukinumab 150 mg s.c. (Secukinumab from week 0 with NSAID tapering allowed from week 4; delayed tapering) at Week 12 is superior to placebo based on the change from baseline in health-related Quality of Life as measured by the SF-36 Physical Component Score (PCS).

  7. Change from baseline in health-related Quality of Life as measured by the SF-36 PCS [ Time Frame: Week 12 ]
    To demonstrate that the efficacy of Secukinumab 150 mg s.c. (Secukinumab from week 4 with NSAID tapering allowed from week 4; early tapering) at Week 12 is superior to placebo based on the change from baseline in health-related Quality of Life as measured by the SF-36 PCS.

  8. Change from baseline in ASAS-NSAID score [ Time Frame: Week 12 ]
    To compare between both Secukinumab regimens concerning the change from baseline in ASAS-NSAID score after 12 weeks of Secukinumab exposure (ASAS-NSAID index at Week 12 for delayed tapering vs. Week 16 for early tapering).

  9. Change from baseline in the Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) [ Time Frame: Week 12 ]
    To compare between both Secukinumab regimens concerning the change from baseline in the Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) after 12 weeks of Secukinumab exposure (BASDAI at Week 12 for delayed tapering vs. Week 16 for early tapering).

  10. Change in patient reported neck, back and hip pain (BASDAI question 2) from baseline [ Time Frame: Week 0-12 ]
    To evaluate change in patient reported neck, back and hip pain (BASDAI question 2) from baseline on a continuous basis in patients randomized Secukinumab 150 mg s.c. (Secukinumab from week 0 with NSAID tapering allowed from week 4; delayed tapering) vs. placebo from week 0 to week 12.

  11. Change in patient reported neck, back and hip pain (BASDAI question 2) from baseline [ Time Frame: Week 0-16 ]
    To evaluate change in patient reported neck, back and hip pain (BASDAI question 2) from baseline on a continuous basis in patients randomized Secukinumab 150 mg s.c. (early tapering) vs. placebo from week 0 to week 16.

  12. Comparison of ASAS20 response rates [ Time Frame: Week 4 vs. Week 20 ]
    To compare ASAS20 response rates at week 4 in Secukinumab 150 mg. s.c. (Secukinumab from week 0 with NSAID tapering allowed from week 4; delayed tapering) vs. week 20 in the patients switching from Placebo after 4 weeks of Secukinumab exposure each.



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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

Key Inclusion Criteria:

  • Diagnosis of active AS with prior documented radiologic evidence fulfilling the Modified New York criteria for AS
  • Active AS assessed by total BASDAI ≥ 4 (0-10) at baseline
  • Spinal pain as measured by BASDAI Question 2 ≥ 4 cm on a 0-10 cm numeric rating scale at baseline
  • Total back pain as measured by VAS ≥ 40 mm (0-100 mm) at baseline
  • Patients should have been on at least 2 different NSAIDs at the highest recommended dose for at least 4 weeks prior to randomization, with an inadequate response or failure to respond, or less if therapy had to be reduced due to intolerance, toxicity or contraindications
  • Patients must report regular intake of NSAIDs of at least 50% of the highest recommended dose at Screening.
  • Patients with prior TNFα inhibitor therapy must report regular intake of NSAIDs of at least 50% of the highest recommended dose at baseline after the appropriate washout
  • Patients are required to be on a stable dose of NSAIDs for at least 2 weeks before randomization
  • Patients who have previously been on a TNFα inhibitor will be allowed entry into study after an appropriate wash-out period prior to randomization
  • Patients who have been on a TNFα inhibitor (not more than two) must have experienced an inadequate response to previous or current treatment given at an approved dose for at least 3 months prior to randomization or have been intolerant to at least one administration of an anti-TNFα agent.
  • Patients taking MTX or sulfasalazine are allowed to continue their medication and must have taken it for at least 3 months and be on a stable dose for at least 4 weeks prior to randomization

Key Exclusion Criteria:

  • Chest X-ray or MRI with evidence of ongoing infectious or malignant process.
  • Previous exposure to Secukinumab or any other biologic drug directly targeting IL-17 or IL-17 receptor
  • Patients previously treated with any biological immunomodulating agents, except those targeting TNFα
  • Patients who have taken more than two anti-TNFα agents
  • Pregnant or nursing (lactating) women.
  • History of ongoing, chronic or recurrent infectious disease or evidence of tuberculosis infection.
  • Patients who are intolerant to NSAIDs

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): NCT02763046


Locations
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Germany
Novartis Investigative Site
Bad Doberan, Germany, 18209
Novartis Investigative Site
Bayreuth, Germany, 95444
Novartis Investigative Site
Berlin, Germany, 12161
Novartis Investigative Site
Berlin, Germany, 12163
Novartis Investigative Site
Berlin, Germany, 13055
Novartis Investigative Site
Berlin, Germany, 13125
Novartis Investigative Site
Berlin, Germany, 13353
Novartis Investigative Site
Berlin, Germany, 14059
Novartis Investigative Site
Chemnitz, Germany, 09130
Novartis Investigative Site
Cottbus, Germany, 03042
Novartis Investigative Site
Dresden, Germany, 01307
Novartis Investigative Site
Elmshorn, Germany, 25335
Novartis Investigative Site
Erlangen, Germany, 91056
Novartis Investigative Site
Frankfurt am Main, Germany, 60528
Novartis Investigative Site
Freiberg, Germany, 09599
Novartis Investigative Site
Freiburg, Germany, 79106
Novartis Investigative Site
Gottingen, Germany, 37075
Novartis Investigative Site
Hamburg, Germany, 22081
Novartis Investigative Site
Hamburg, Germany, 22143
Novartis Investigative Site
Hamburg, Germany, 22415
Novartis Investigative Site
Heidelberg, Germany, 69120
Novartis Investigative Site
Herne, Germany, 44649
Novartis Investigative Site
Koeln, Germany, 51149
Novartis Investigative Site
Leipzig, Germany, 04103
Novartis Investigative Site
Leipzig, Germany, 04109
Novartis Investigative Site
Lubeck, Germany, 23538
Novartis Investigative Site
Magdeburg, Germany, 39104
Novartis Investigative Site
Magdeburg, Germany, 39110
Novartis Investigative Site
Muenchen, Germany, 81541
Novartis Investigative Site
Muenchen, Germany, 81675
Novartis Investigative Site
München, Germany, 80331
Novartis Investigative Site
Nienburg, Germany, 31582
Novartis Investigative Site
Nuernberg, Germany, 90443
Novartis Investigative Site
Puettlingen/saar, Germany, 66346
Novartis Investigative Site
Rendsburg, Germany, 24768
Novartis Investigative Site
Saarbruecken, Germany, 66111
Novartis Investigative Site
Schwerin, Germany, 19055
Novartis Investigative Site
Sendenhorst, Germany, 48324
Novartis Investigative Site
Trier, Germany, 54292
Novartis Investigative Site
Wuppertal, Germany, 42105
Sponsors and Collaborators
Novartis Pharmaceuticals

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Responsible Party: Novartis Pharmaceuticals
ClinicalTrials.gov Identifier: NCT02763046     History of Changes
Other Study ID Numbers: CAIN457FDE03
2015-004575-74 ( EudraCT Number )
First Posted: May 5, 2016    Key Record Dates
Last Update Posted: June 11, 2019
Last Verified: June 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
Plan Description:

Novartis is committed to sharing access to patient-level data and supporting clinical documents from eligible studies with qualified external researchers. Requests are reviewed and approved by an independent review panel on the basis of scientific merit. All data provided is anonymized to protect 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: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Novartis ( Novartis Pharmaceuticals ):
Ankylosing Spondylitis
NSAID
ASAS
Secukinumab
Subcutaneous

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
Anti-Inflammatory Agents, Non-Steroidal
Antibodies, Monoclonal
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-Inflammatory Agents
Antirheumatic Agents
Immunologic Factors