Spondylitis, Ankylosing Clinical Trial
— MEASURE 3Official title:
A Randomized, Double-blind, Placebo-controlled Phase III Study of Secukinumab to Demonstrate the Efficacy at 16 Weeks and to Assess the Long-term Safety, Tolerability and Efficacy up to 3 Years in Subjects With Active Ankylosing Spondylitis
Verified date | December 2018 |
Source | Novartis |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
The purpose of this study was to generate 16-week efficacy data, as well as up to 3-year efficacy, safety and tolerability data in subjects with active AS despite current or previous NSAID, DMARD and/or anti-TNF therapy.
Status | Completed |
Enrollment | 226 |
Est. completion date | December 11, 2017 |
Est. primary completion date | February 23, 2015 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility | Inclusion criteria: moderate to severe AS, prior radiographic evidence according to the Modified NY Criteria (1984), inadequate response to NSAIDs. -- Exclusion criteria: pregnancy or lactation, on-going infectious or malignant process on a chest X-ray or MRI, previous exposure to IL-17 or IL-17R targeting therapies, previous exposure to any biological immunomodulating agent excluding TNF antagonists, previous cell depleting therapy. |
Country | Name | City | State |
---|---|---|---|
Belgium | Novartis Investigative Site | Aalst | |
Belgium | Novartis Investigative Site | Bruxelles | |
Czechia | Novartis Investigative Site | Praha 2 | |
Czechia | Novartis Investigative Site | Uherske Hradiste | Czech Republic |
Germany | Novartis Investigative Site | Bad Doberan | |
Germany | Novartis Investigative Site | Berlin | |
Germany | Novartis Investigative Site | Berlin | |
Germany | Novartis Investigative Site | Cottbus | |
Germany | Novartis Investigative Site | Erlangen | |
Germany | Novartis Investigative Site | Erlangen | |
Germany | Novartis Investigative Site | Gottingen | |
Germany | Novartis Investigative Site | Hamburg | |
Germany | Novartis Investigative Site | Hannover | |
Germany | Novartis Investigative Site | Herne | |
Germany | Novartis Investigative Site | Jena | |
Germany | Novartis Investigative Site | Magdeburg | |
Germany | Novartis Investigative Site | Muenchen | |
Germany | Novartis Investigative Site | Zerbst | |
Greece | Novartis Investigative Site | Athens | GR |
Greece | Novartis Investigative Site | Athens | |
Greece | Novartis Investigative Site | Athens | |
Greece | Novartis Investigative Site | Heraklion | |
Greece | Novartis Investigative Site | Thessaloniki | GR |
Mexico | Novartis Investigative Site | Culiacan | MEX |
Mexico | Novartis Investigative Site | Mexicali | Baja California |
Mexico | Novartis Investigative Site | Torreon | Coahuila |
Portugal | Novartis Investigative Site | Almada | |
Portugal | Novartis Investigative Site | Lisboa | |
Portugal | Novartis Investigative Site | Lisboa | |
Portugal | Novartis Investigative Site | Lisboa | |
Russian Federation | Novartis Investigative Site | Kazan | |
Russian Federation | Novartis Investigative Site | Moscow | |
Russian Federation | Novartis Investigative Site | St Petersburg | |
Russian Federation | Novartis Investigative Site | St-Petersburg | |
Spain | Novartis Investigative Site | Cordoba | Andalucia |
Spain | Novartis Investigative Site | El Palmar | Murcia |
Spain | Novartis Investigative Site | La Coruna | Galicia |
Spain | Novartis Investigative Site | Madrid | |
Spain | Novartis Investigative Site | Sabadell | Barcelona |
Spain | Novartis Investigative Site | Santander | Cantabria |
United Kingdom | Novartis Investigative Site | London | England |
United Kingdom | Novartis Investigative Site | Norwich | |
United Kingdom | Novartis Investigative Site | Torquay | |
United States | Novartis Investigative Site | Albany | New York |
United States | Novartis Investigative Site | Austin | Texas |
United States | Novartis Investigative Site | Charleston | South Carolina |
United States | Novartis Investigative Site | Duncansville | Pennsylvania |
United States | Novartis Investigative Site | Jackson | Tennessee |
United States | Novartis Investigative Site | Mesa | Arizona |
United States | Novartis Investigative Site | Mesquite | Texas |
United States | Novartis Investigative Site | Mobile | Alabama |
United States | Novartis Investigative Site | Oklahoma City | Oklahoma |
United States | Novartis Investigative Site | Palm Harbor | Florida |
United States | Novartis Investigative Site | Passaic | New Jersey |
United States | Novartis Investigative Site | Pembroke Pines | Florida |
United States | Novartis Investigative Site | Peoria | Arizona |
United States | Novartis Investigative Site | Upland | California |
Lead Sponsor | Collaborator |
---|---|
Novartis Pharmaceuticals |
United States, Belgium, Czechia, Germany, Greece, Mexico, Portugal, Russian Federation, Spain, United Kingdom,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Number of Participants With 20% Improvement in the Assessment of Spondyloarthritis International Society Criteria Scale / ASAS 20 Response | ASAS 20 response is a validated composite assessment, reflecting the proportion of treated patients who achieve within a defined time frame at least 20% improvement in score in at least 3 of a conventional set of 4 clinical domains relevant to AS and no worsening in the fourth domain. In this study, ASAS 20 was used to assess the efficacy of at least one dose of secukinumab versus placebo. | 16 weeks | |
Secondary | ASAS 40 Response | ASAS 40 response is a validated composite assessment, reflecting the proportion of treated patients who achieve within a defined time frame at least 40% improvement in score in at least 3 of a conventional set of 4 clinical domains relevant to AS and no worsening in the fourth domain. In this study, ASAS 40 was used to assess the efficacy of at least one dose of secukinumab versus placebo. | 16 weeks | |
Secondary | Serum hsCRP | Blood levels of C-reactive protein (CRP), an acute phase reactant, are indicative of inflammation and of its severity, and can be used to monitor treatment response. A high sensitivity CRP (hsCRP) test was implemented in this study, to assess the efficacy of at least one dose of secukinumab versus placebo in reducing AS elicited systemic inflammation over the time. | Baseline and 16 weeks | |
Secondary | ASAS 5/6 Response | ASAS 5/6 response is a validated composite assessment, reflecting the proportion of treated patients who achieve within a defined time frame at least 20% improvement in score in at least 5 of a conventional set of 6 clinical domains relevant to AS and no worsening in the remaining domain. In this study, ASAS 5/6 was used to assess the efficacy of at least one dose of secukinumab versus placebo. | 16 weeks | |
Secondary | Bath Ankylosing Spondylitis Disease Activity Index / BASDAI | BASDAI is a validated assessment tool using 0 through 10 scales (0 indicating "no problem" and 10 indicating "worst problem"), to characterise six clinical domains pertaining to five major symptoms of AS perceived by the patients. Computed composite scores of 4 or greater indicate suboptimal disease control. In this study, the BASDAI index was used to assess the efficacy of at least one dose of secukinumab versus placebo. | Baseline and 16 weeks | |
Secondary | Number of Participants With Successful Self-administration (to Measure Usability of Pre-filled Syringe) | Successful self-administration is defined as success in steps P8 (Removed Needle Cap from Safety Syringe), P10 (Pinched the Skin at Injection Site), P11 (Inserted the Needle into Skin), P12 (Held onto the Finger Flange), P13 (Fully Depressed Plunger until End Point), and P14 (Held Plunger Down and Syringe in Place) of the Instructions for Use, as observed by the site staff at applicable visits. | Week 8 and Week 12 | |
Secondary | Pre-filled Syringe Possible Hazard | The number and percentage of subjects who experience any of the defined possible hazards are summarized, as defined in the Possible Hazard assessment check list and as observed by the site staff at applicable visits. | Week 8 and Week 12 | |
Secondary | Prefilled Syringe Patient Satisfaction Assessment | The self-injection assessment questionnaire (SIAQ) measures overall patient experience with subcutaneous self-injection at applicable visits. Domain scores ranging from 0 (worst experience) to 10 (best experience) are presented: Feeling about injections, Self-confidence, Satisfaction with self-injection. | Baseline, weeks 8, 12 and 16 | |
Secondary | ASAS Partial Remission | ASAS partial remission is a composite assessment, reflecting the proportion of treated patients who achieve within a defined time frame a value not above 2 units in each of the 4 ASAS domains on a scale of 10. In this study, ASAS partial remission was used to assess the efficacy of at least one dose of secukinumab versus placebo. | 16 weeks |
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