Study to Examine the Clinical Efficacy and the Nonsteroidal Anti-inflammatory Drug (NSAID)-Sparing Effect of Secukinumab Over 16 Weeks in Patients With Ankylosing Spondylitis

• Register: ClinicalTrials.gov
• Last refreshed on: 18 October 2021
• Main ID: NCT02763046
• Date of registration: 03/05/2016
• Prospective Registration: Yes
• Primary sponsor: Novartis Pharmaceuticals
• Public title: Study 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
• Scientific 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)
• Date of first enrolment: May 31, 2016
• Target sample size: 211
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/show/NCT02763046
• Study type: Interventional
• Study design: Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: Triple (Participant, Care Provider, Investigator).
• Phase: Phase 4

Countries of recruitment

Germany

Key inclusion & exclusion 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 TNFa 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 TNFa inhibitor will be allowed entry into study
after an appropriate wash-out period prior to randomization

- Patients who have been on a TNFa 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-TNFa 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 TNFa

- Patients who have taken more than two anti-TNFa 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



Age minimum: 18 Years
Age maximum: N/A
Gender: All

Health Condition(s) or Problem(s) studied

Ankylosing Spondylitis

Intervention(s)

Drug: Placebo - Secukinumab (AIN457) 150 mg s.c.

Drug: Secukinumab (AIN457) 150 mg s.c.

Primary Outcome(s)

Proportion of Patients Who Achieved ASAS20 Response in the Pooled Secukinumab Group Compared With the Placebo Group at Week 12 [Time Frame: Baseline, Week 12]

Secondary Outcome(s)

Mean Change From Baseline in Health-related Quality of Life as Measured by the Short Form-36 Health Survey (SF-36) Physical Component Summary (PCS) Score [Time Frame: Baseline, Week 12]

Mean Change From Baseline in the BASDAI Total Score [Time Frame: Baseline, Week 12, Week 16]

Proportion of Patients Who Achieved ASAS20 Response in Each Secukinumab Group (Delayed NSAID Tapering and Early NSAID Tapering) Compared With the Placebo Group [Time Frame: Baseline, Week 12, Week 16]

Mean Change From Baseline in ASAS-NSAID Score at Week 12 [Time Frame: Baseline, Week 12]

Mean Change From Baseline in ASAS-NSAID Score in Each Secukinumab Group After 12 Weeks of Exposure (at Week 12 in the Secukinumab-delayed NSAID Tapering Group and at Week 16 in the Secukinumab-early NSAID Tapering Group) [Time Frame: Baseline, Week 12 (delayed NSAID tapering), Week 16 (early NSAID tapering)]

Secondary ID(s)

2015-004575-74

CAIN457FDE03

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Results

• Results available: Yes
• Date Posted: 09/10/2020
• URL: https://clinicaltrials.gov/ct2/show/results/NCT02763046