16 Week Efficacy and 5 Year Long Term Efficacy, Safety and Tolerability of Secukinumab in Patients With Active Ankylosing Spondylitis (MEASURE2)
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| ClinicalTrials.gov Identifier: NCT01649375 |
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Recruitment Status :
Completed
First Posted : July 25, 2012
Results First Posted : October 30, 2019
Last Update Posted : October 30, 2019
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Sponsor:
Novartis Pharmaceuticals
Information provided by (Responsible Party):
Novartis ( Novartis Pharmaceuticals )
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| Study Type | Interventional |
|---|---|
| Study Design | Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor); Primary Purpose: Treatment |
| Condition |
Anklyosing Spondylitis |
| Interventions |
Drug: Secukinumab (75 mg) Drug: Placebo Drug: Secukinumab (150 mg) |
| Enrollment | 219 |
Participant Flow
| Recruitment Details | |
| Pre-assignment Details |
| Arm/Group Title | Secukinumab 75 mg | Secukinumab 150 mg | Placebo | Placebo - Secukinumab 75 mg | Placebo - Secukinumab 150 mg |
|---|---|---|---|---|---|
 Arm/Group Description |
Secukinumab 75 mg subcutaneous injection once weekly at baseline, Weeks 1, 2, 3 and 4, followed by dosing every 4 weeks. | Secukinumab 150 mg subcutaneous injection once weekly at baseline, Weeks 1, 2, 3 and 4, followed by dosing every 4 weeks | Placebo subcutaneous injection once weekly at baseline, Weeks 1, 2, 3 and 4, followed by dosing every 4 weeks up to week 16 | Placebo patients re-randomized to secukinumab 75 mg subcutaneous injection every 4 weeks starting from week 16. | Placebo patients re-randomized to secukinumab 150 mg subcutaneous injection every 4 weeks starting from week 16. |
| Period Title: Up to Week 16 | |||||
| Started | 73 | 72 | 74 | 0 | 0 |
| Completed | 68 | 66 | 66 | 0 | 0 |
| Not Completed | 5 | 6 | 8 | 0 | 0 |
| Reason Not Completed | |||||
| Adverse Event | 2 | 5 | 4 | 0 | 0 |
| Lack of Efficacy | 0 | 0 | 1 | 0 | 0 |
| Physician Decision | 0 | 0 | 1 | 0 | 0 |
| Withdrawal by Subject | 2 | 1 | 2 | 0 | 0 |
| Death | 1 | 0 | 0 | 0 | 0 |
| Period Title: Week 16 up to Week 260 | |||||
| Started | 68 | 66 | 0 | 32 | 34 |
| Completed | 48 | 53 | 0 | 20 | 29 |
| Not Completed | 20 | 13 | 0 | 12 | 5 |
| Reason Not Completed | |||||
| Lack of Efficacy | 7 | 4 | 0 | 4 | 2 |
| Non-compliance | 0 | 1 | 0 | 1 | 0 |
| Physician Decision | 0 | 2 | 0 | 0 | 0 |
| Technical issues | 0 | 1 | 0 | 1 | 0 |
| Withdrawal by Subject | 7 | 2 | 0 | 3 | 1 |
| Death | 1 | 1 | 0 | 0 | 0 |
| Adverse Event | 5 | 2 | 0 | 3 | 2 |
Baseline Characteristics
| Arm/Group Title | Secukinumab 75 mg | Secukinumab 150 mg | Placebo | Total | |
|---|---|---|---|---|---|
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Arm/Group Description |
Secukinumab 75 mg subcutaneous injection once weekly at baseline, Weeks 1, 2, 3 and 4, followed by dosing every 4 weeks. | Secukinumab 150 mg subcutaneous injection once weekly at baseline, Weeks 1, 2, 3 and 4, followed by dosing every 4 weeks | Placebo subcutaneous injection once weekly at baseline, Weeks 1, 2, 3 and 4, followed by dosing every 4 weeks up to week 16 | Total of all reporting groups | |
| Overall Number of Baseline Participants | 73 | 72 | 74 | 219 | |
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Baseline Analysis Population Description |
[Not Specified]
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Age, Customized
Measure Type: Number Unit of measure: Participants |
Number Analyzed | 73 participants | 72 participants | 74 participants | 219 participants |
| < 65 years | 70 | 70 | 72 | 212 | |
| >= 65 to 74 years | 2 | 2 | 1 | 5 | |
| >= 75 years | 1 | 0 | 1 | 2 | |
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Sex: Female, Male
Measure Type: Count of Participants Unit of measure: Participants |
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| Number Analyzed | 73 participants | 72 participants | 74 participants | 219 participants | |
| Female |
22 30.1%
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26 36.1%
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18 24.3%
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66 30.1%
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| Male |
51 69.9%
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46 63.9%
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56 75.7%
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153 69.9%
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Race/Ethnicity, Customized
Measure Type: Number Unit of measure: Participants |
Number Analyzed | 73 participants | 72 participants | 74 participants | 219 participants |
| White | 70 | 69 | 70 | 209 | |
| Asian | 3 | 2 | 4 | 9 | |
| American Indian or Alaska Native | 0 | 1 | 0 | 1 | |
Outcome Measures
Adverse Events
Limitations and Caveats
[Not Specified]
More Information
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts
the PI's rights to discuss or publish trial results after the trial is completed.
The terms and conditions of Novartis' agreements with its investigators may vary. However, Novartis does not prohibit any investigator from publishing. Any publications from a single-site are postponed until the publication of the pooled data (ie, data from all sites) in the clinical trial
Results Point of Contact
| Name/Title: | Study Director |
| Organization: | Novartis Pharmaceuticals |
| Phone: | 862-778-8300 |
| EMail: | Novartis.email@novartis.com |
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
| Responsible Party: | Novartis ( Novartis Pharmaceuticals ) |
| ClinicalTrials.gov Identifier: | NCT01649375 |
| Other Study ID Numbers: |
CAIN457F2310 2012-000046-35 ( EudraCT Number ) |
| First Submitted: | July 20, 2012 |
| First Posted: | July 25, 2012 |
| Results First Submitted: | July 24, 2019 |
| Results First Posted: | October 30, 2019 |
| Last Update Posted: | October 30, 2019 |