Efficacy and Safety Study of Adalimumab in the Treatment of Hidradenitis Suppurativa (PIONEER II)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
AbbVie ( AbbVie (prior sponsor, Abbott) )
ClinicalTrials.gov Identifier:
NCT01468233
First received: November 7, 2011
Last updated: October 15, 2015
Last verified: October 2015
Results First Received: September 16, 2015  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Double Blind (Subject, Investigator);   Primary Purpose: Treatment
Condition: Hidradenitis Suppurativa (HS)
Interventions: Biological: adalimumab
Biological: placebo

  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
Participants ≥ 18 years of age with HS for at least 1 year prior to Baseline and HS lesions present in at least 2 distinct anatomical areas (one of which must be at least Hurley Stage II or III) who had experienced inadequate response to ≥ 90 day treatment of oral antibiotics for HS were eligible for enrolment in the study.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
No text entered.

Reporting Groups
  Description
Placebo Placebo for 12 weeks
Adalimumab Every Week (EW) Adalimumab ew for 12 weeks (160 mg at Week 0; 80 mg at Week 2; and 40 mg ew from Week 4 to Week 12).
Placebo/Placebo Participants randomized to receive placebo in Period 1 received placebo every week from Week 12 to Week 35 in Period 2 (up to 24 weeks).
Adalimumab Every Week (EW)/Placebo Participants randomized to receive adalimumab ew in Period 1 were re-randomized to receive placebo ew from Week 12 to Week 35 in Period 2 (up to 24 weeks).
Adalimumab Every Week (EW)/ Adalimumab Every Other Week (EOW) Participants randomized to receive adalimumab ew in Period 1 were re-randomized to receive 40 mg adalimumab eow from Week 12 to Week 35 in Period 2; placebo injections were administered eow from Week 13 to Week 35 (up to 24 weeks).
Adalimumab Every Week (EW)/Adalimumab Every Week (EW) Participants randomized to receive adalimumab ew in Period 1 were re-randomized to receive 40 mg adalimumab ew from Week 12 to Week 35 in Period 2 (up to 24 weeks).

Participant Flow for 2 periods

Period 1:   Treatment Period 1
    Placebo     Adalimumab Every Week (EW)     Placebo/Placebo     Adalimumab Every Week (EW)/Placebo     Adalimumab Every Week (EW)/ Adalimumab Every Other Week (EOW)     Adalimumab Every Week (EW)/Adalimumab Every Week (EW)  
STARTED     163     163     0     0     0     0  
COMPLETED     151     155     0     0     0     0  
NOT COMPLETED     12     8     0     0     0     0  
Adverse Event                 5                 3                 0                 0                 0                 0  
Withdrawal by Subject                 3                 4                 0                 0                 0                 0  
Lost to Follow-up                 3                 0                 0                 0                 0                 0  
Not specified                 1                 1                 0                 0                 0                 0  

Period 2:   Treatment Period 2
    Placebo     Adalimumab Every Week (EW)     Placebo/Placebo     Adalimumab Every Week (EW)/Placebo     Adalimumab Every Week (EW)/ Adalimumab Every Other Week (EOW)     Adalimumab Every Week (EW)/Adalimumab Every Week (EW)  
STARTED     0     0     151     51     53     51  
COMPLETED     0     0     40     23     25     28  
NOT COMPLETED     0     0     111     28     28     23  
Adverse Event                 0                 0                 3                 0                 2                 1  
Lack of Efficacy                 0                 0                 9                 2                 0                 1  
Withdrawal by Subject                 0                 0                 9                 1                 1                 1  
Loss/absence of response (per protocol)                 0                 0                 84                 25                 22                 20  
Lost to Follow-up                 0                 0                 3                 0                 2                 0  
Not specified                 0                 0                 3                 0                 1                 0  



  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.
No text entered.

Reporting Groups
  Description
Placebo Placebo for 12 weeks
Adalimumab Every Week (EW) Adalimumab ew for 12 weeks (160 mg at Week 0; 80 mg at Week 2; and 40 mg ew from Week 4 to Week 12).
Total Total of all reporting groups

Baseline Measures
    Placebo     Adalimumab Every Week (EW)     Total  
Number of Participants  
[units: participants]
  163     163     326  
Age  
[units: years]
Mean (Standard Deviation)
  36.1  (12.18)     34.9  (9.96)     35.5  (11.13)  
Gender  
[units: participants]
     
Female     113     108     221  
Male     50     55     105  



  Outcome Measures
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1.  Primary:   Percentage of Participants Achieving Hidradenitis Suppurativa Clinical Response (HiSCR) at Week 12   [ Time Frame: Baseline (Week 0) up to Week 12 ]

2.  Secondary:   Percentage of Participants With Baseline Hurley Stage II Who Achieved Abscess and Inflammatory Nodule (AN) Count of 0, 1, or 2 at Week 12   [ Time Frame: Baseline (Week 0) up to Week 12 ]

3.  Secondary:   Percentage of Participants Achieving At Least 30% Reduction and At Least 1 Unit Reduction From Baseline in Patient's Global Assessment of Skin Pain (NRS30) – At Worst at Week 12 Among Participants With Baseline Skin Pain NRS ≥ 3   [ Time Frame: Baseline (Week 0) up to Week 12 ]

4.  Secondary:   Change From Baseline to Week 12 in Modified Sartorius Score   [ Time Frame: Baseline (Week 0) and Week 12 ]


  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: Global Medical Information
Organization: AbbVie (prior sponsor, Abbott)
phone: 800-633-9110



Responsible Party: AbbVie ( AbbVie (prior sponsor, Abbott) )
ClinicalTrials.gov Identifier: NCT01468233     History of Changes
Other Study ID Numbers: M11-810
2011-003406-24 ( EudraCT Number )
Study First Received: November 7, 2011
Results First Received: September 16, 2015
Last Updated: October 15, 2015
Health Authority: Australia: National Health and Medical Research Council
Canada: Health Canada
Denmark: Ministry of Health
France: Afssaps - Agence francaise de securite sanitaire des produits de sante (Saint-Denis)
Netherlands: The Central Committee on Research Involving Human Subjects (CCMO)
Sweden: Medical Products Agency
Switzerland: Ethikkommission
Turkey: Ministry of Health
United States: Food and Drug Administration
Greece: National Organization of Medicines