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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT03259074




Registration number
NCT03259074
Ethics application status
Date submitted
21/08/2017
Date registered
23/08/2017

Titles & IDs
Public title
Effect of Secukinumab on Radiographic Progression in Ankylosing Spondylitis as Compared to GP2017 (Adalimumab Biosimilar)
Scientific 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
Secondary ID [1] 0 0
CAIN457K2340
Universal Trial Number (UTN)
Trial acronym
SURPASS
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Ankylosing Spondylitis 0 0
Condition category
Condition code
Inflammatory and Immune System 0 0 0 0
Other inflammatory or immune system disorders
Musculoskeletal 0 0 0 0
Other muscular and skeletal disorders
Inflammatory and Immune System 0 0 0 0
Rheumatoid arthritis

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Other - Placebo
Treatment: Other - GP2017 (adalimumab biosimilar)
Treatment: Other - AIN457 150 mg

Experimental: AIN457 150 mg/placebo - AIN457 150 mg and a matching placebo was administered subcutaneously via pre-filled syringes at Baseline, Weeks 1, 2, 3 and 4, followed by dosing every 4 weeks until Week 100

Experimental: AIN457 300 mg - AIN457 300 mg (2 x 150 mg) was administered subcutaneously via pre-filled syringes at Baseline, Weeks 1, 2, 3 and 4, followed by dosing every 4 weeks until Week 100

Active comparator: GP2017 40mg - GP2017 (adalimumab biosimilar) 40 mg was administered subcutaneously via pre-filled syringes at Baseline followed by dosing every 2 weeks until Week 102


Treatment: Other: Placebo
Matching placebo to AIN457 150 mg dose administered with AIN457 via pre-filled syringes

Treatment: Other: GP2017 (adalimumab biosimilar)
40 mg in pre-filled syringes was administered subcutaneously

Treatment: Other: AIN457 150 mg
150 mg in pre-filled syringes was administered subcutaneously
Intervention code [1] 0 0
Treatment: Other
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Percentage of Participants With no Radiographic Progression at Week 104 (Multiple Imputation) (Full Analysis Set)
Timepoint [1] 0 0
Baseline and at Week 104
Secondary outcome [1] 0 0
Change From Baseline in mSASSS at Week 104 (Multiple Imputation) (Full Analysis Set)
Timepoint [1] 0 0
Baseline and at Week 104
Secondary outcome [2] 0 0
Percentage of Participants Without New Syndesmophytes by mSASSS Between Baseline and Week 104 (Multiple Imputation) (Syndesmophyte Subset)
Timepoint [2] 0 0
Baseline and at Week 104
Secondary outcome [3] 0 0
Change From Baseline in MRI Berlin Sacroiliac (SI) Joint Edema Score (Observed Data) (MRI Subset)
Timepoint [3] 0 0
Baseline and at Week 104
Secondary outcome [4] 0 0
Change From Baseline in Berlin Modification of ASspiMRI-a Edema Score (MRI Subset)
Timepoint [4] 0 0
Baseline and at Week 104
Secondary outcome [5] 0 0
Percentage of Responders for Assessment of SpondyloArthritis International Society 20 (ASAS20)
Timepoint [5] 0 0
Week 104
Secondary outcome [6] 0 0
Percentage of Responders for Assessment of SpondyloArthritis International Society 40 (ASAS 40)
Timepoint [6] 0 0
Week 104
Secondary outcome [7] 0 0
Percentage of Responders for Assessment of SpondyloArthritis International Society With a Partial Remission Response (Full Analysis Set)
Timepoint [7] 0 0
Week 104
Secondary outcome [8] 0 0
Percentage of Participants With Assessment of SpondyloArthritis International Society for Inactive Disease Response (Observed Data) (Full Analysis Set)
Timepoint [8] 0 0
Week 104

Eligibility
Key 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
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key 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 TNFa
* 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

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?


The people assessing the outcomes
Intervention assignment
Parallel
Other design features
Phase
Phase 3
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
30/11/2017
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
29/11/2021
Sample size
Target
Accrual to date
Final
859
Recruitment in Australia
Recruitment state(s)
VIC
Recruitment hospital [1] 0 0
Novartis Investigative Site - Malvern East
Recruitment postcode(s) [1] 0 0
3145 - Malvern East
Recruitment outside Australia
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Dorset
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Edmonton
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GBR
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Torquay
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Wolverhampton

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
Novartis Pharmaceuticals
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
What data in particular will be shared?
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
When will data be available (start and end dates)?
Available to whom?
Available for what types of analyses?
How or where can data be obtained?


What supporting documents are/will be available?




Results publications and other study-related documents

No documents have been uploaded by study researchers.


Results are available at https://clinicaltrials.gov/study/NCT03259074