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Efficacy at 24 Weeks and Long Term Safety, Tolerability and Efficacy up to 2 Years of Secukinumab (AIN457) in Patients With Active Psoriatic Arthritis (PsA) (FUTURE 1)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Novartis ( Novartis Pharmaceuticals )
ClinicalTrials.gov Identifier:
NCT01392326
First received: July 7, 2011
Last updated: January 5, 2016
Last verified: January 2016
Results First Received: October 20, 2015  
Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Condition: Psoriatic Arthritis
Interventions: Drug: Secukinumab (75 mg)
Drug: Secukinumab (150 mg)
Drug: Placebo Comparator

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
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Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
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Reporting Groups
  Description
AIN457 (75 mg) Secukinumab (75mg)
AIN457 (150 mg) Secukinumab (150 mg)
Placebo Match for AIN457 ( 75 and 150 mg) Placebo match (for 75 and 150 mg)

Participant Flow:   Overall Study
    AIN457 (75 mg)   AIN457 (150 mg)   Placebo Match for AIN457 ( 75 and 150 mg)
STARTED   202   202   202 
COMPLETED   155   167   154 
NOT COMPLETED   47   35   48 
Death                2                0                0 
Withdrawal by Subject                12                11                15 
Protocol Violation                2                0                0 
Pregnancy                0                0                1 
Physician Decision                7                5                2 
Lost to Follow-up                1                3                4 
Lack of Efficacy                14                10                15 
Adverse Event                9                6                11 



  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
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Reporting Groups
  Description
Group 1 Secukinumab (75mg)
Group 2 Secukinumab (150 mg)
Group 3 Placebo match (for 75 and 150 mg)
Total Total of all reporting groups

Baseline Measures
   Group 1   Group 2   Group 3   Total 
Overall Participants Analyzed 
[Units: Participants]
 202   202   202   606 
Age 
[Units: Participants]
       
<=18 years   0   0   0   0 
Between 18 and 65 years   180   180   192   552 
>=65 years   22   22   10   54 
Gender 
[Units: Participants]
       
Female   118   106   106   330 
Male   84   96   96   276 


  Outcome Measures
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1.  Primary:   Percent of Patients Achieving ACR20 Response Criteria on Secukinumab 75 or 150 mg vs. Placebo   [ Time Frame: Week 24 ]

2.  Secondary:   Percent of Subjects Achieving a PASI75 Response in the Subgroup of Subjects Who Have ≥3% Skin Involvement With Psoriasis at Baseline   [ Time Frame: Week 24 ]

3.  Secondary:   Percent of Subjects Achieving a PASI90 Response in the Subgroup of Subjects Who Have ≥3% Skin Involvement With Psoriasis at Baseline   [ Time Frame: Week 24 ]

4.  Secondary:   Change From Baseline in DAS28-CRP for Secukinumab 75 or 150 mg   [ Time Frame: Week 24 ]

5.  Secondary:   Change From Baseline in SF36-PCS for Secukinumab 75 or 150 mg   [ Time Frame: Week 24 ]

6.  Secondary:   Change From Baseline in HAQ-DI for Secukinumab 75 or 150 mg   [ Time Frame: Week 24 ]

7.  Secondary:   Percent of Patients Achieving ACR50 Response Criteria on Secukinumab 75 or 150 mg vs. Placebo   [ Time Frame: Week 24 ]

8.  Secondary:   Change From Baseline for Joint/Bone Structural Damage (Van Der Heijde Modified Total Sharp Score) for Secukinumab 75 and 150 mg (Pooled Doses)   [ Time Frame: Week 24 ]

9.  Secondary:   Percent of Patients With Dactylitis in the Subset of Subjects Who Have Dactylitis at Baseline   [ Time Frame: Week 24 ]

10.  Secondary:   Percent of Patients With Enthesitis in the Subset of Subjects Who Have Enthesitis at Baseline   [ Time Frame: Week 24 ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
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  More Information
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Certain Agreements:  
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 agreement is:
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 60 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is more than 60 days but less than or equal to 180 days. The sponsor cannot require changes to the communication and cannot extend the embargo.


Results Point of Contact:  
Name/Title: Clinical Disclosure Office
Organization: Novartis Pharmaceuticals
phone: 862-778-8300


Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Responsible Party: Novartis ( Novartis Pharmaceuticals )
ClinicalTrials.gov Identifier: NCT01392326     History of Changes
Other Study ID Numbers: CAIN457F2306
2011-000276-34 ( EudraCT Number )
Study First Received: July 7, 2011
Results First Received: October 20, 2015
Last Updated: January 5, 2016
Health Authority: United States: Food and Drug Administration
Argentina: Administracion Nacional de Medicamentos, Alimentos y Tecnologia Medica
Australia: Department of Health and Ageing Therapeutic Goods Administration
Belgium: Federal Agency for Medicinal Products and Health Products
Brazil: National Health Surveillance Agency
Bulgaria: Bulgarian Drug Agency
Canada: Health Canada
Czech Republic: State Institute for Drug Control
Germany: Federal Institute for Drugs and Medical Devices
Israel: Ministry of Health
Italy: Ethics Committee
Peru: Ministry of Health
Philippines: Department of Health
Poland: Ministry of Health
Romania: National Medicines Agency
Russia: Ministry of Health of the Russian Federation
Singapore: Health Sciences Authority
Slovakia: State Institute for Drug Control
Thailand: Ethical Committee
Turkey: Ministry of Health
United Kingdom: Medicines and Healthcare Products Regulatory Agency