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Adalimumab in Combination With Topical Treatment (Calcipotriol/Betamethasone) in Subjects With Moderate to Severe Psoriasis and Insufficient Response to Classic Systemic Treatment (BELIEVE)
This study has been completed.
Study NCT00574249   Information provided by Abbott

First Received on December 12, 2007.   Last Updated on April 11, 2011   History of Changes
Results First Received: October 29, 2009  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Condition: Chronic Plaque Psoriasis
Interventions: Biological: adalimumab
Drug: Calcipotriol/Betamethasone Ointment
Drug: placebo (vehicle ointment)

  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
Adalimumab + Placebo adalimumab + placebo (vehicle ointment): subcutaneous injection using prefilled pen/syringe, solution containing 40 mg adalimumab in 0.8 milliliters; 2 injections given at Baseline (Day 1) then one injection every other week from Week 1 through Week 15 - placebo vehicle ointment to be applied once daily to affected psoriasis skin on trunk and extremities for first 4 weeks and as needed from Week 5 though Week 16 (maximum dose of 100 g per week)
Adalimumab + Calcipotriol/Betamethasone adalimumab + calcipotriol/betamethasone ointment: subcutaneous injection using prefilled pen/syringe, solution containing 40 mg adalimumab in 0.8 milliliters; 2 injections given at Baseline (Day 1) then one injection every other week from Week 1 though Week 15 - topical ointment (calcipotriol 50 mcg/g and betamethasone 500 mg/g) to be applied once daily to affected psoriasis skin on trunk and extremities for first 4 weeks and as needed from Week 5 through Week 16 (maximum 100 g per week)

Participant Flow:   Overall Study
    Adalimumab + Placebo     Adalimumab + Calcipotriol/Betamethasone  
STARTED     364     366  
COMPLETED     338     338  
NOT COMPLETED     26     28  
Adverse Event                 6                 18  
Lack of Efficacy                 5                 3  
Lost to Follow-up                 4                 3  
Protocol Violation                 5                 2  
History of carcinoma                 1                 0  
Withdrawal by Subject                 3                 0  
Physician Decision                 1                 0  
Pregnancy                 1                 0  
Excluded by company                 0                 1  
PPD test taken twice                 0                 1  



  Baseline Characteristics
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Reporting Groups
  Description
Adalimumab + Placebo adalimumab + placebo (vehicle ointment): subcutaneous injection using prefilled pen/syringe, solution containing 40 mg adalimumab in 0.8 milliliters; 2 injections given at Baseline (Day 1) then one injection every other week from Week 1 through Week 15
Adalimumab + Calcipotriol/Betamethasone adalimumab + calcipotriol/betamethasone ointment

Baseline Measures
    Adalimumab + Placebo     Adalimumab + Calcipotriol/Betamethasone     Total  
Number of Participants  
[units: participants]
 		  364     366     730  
Age  
[units: participants]
 		     
<=18 years     0     1     1  
Between 18 and 65 years     343     350     693  
>=65 years     21     15     36  
Age  
[units: years]
Mean ± Standard Deviation 		  44.8  ± 12.61     45.3  ± 11.95     45.1  ± 12.28  
Gender  
[units: participants]
 		     
Female     113     116     229  
Male     251     250     501  
Region of Enrollment  
[units: participants]
 		     
Austria     12     12     24  
Belgium     40     36     76  
Czech Republic     8     10     18  
Denmark     15     15     30  
Finland     5     6     11  
France     58     61     119  
Germany     79     83     162  
Greece     12     12     24  
Italy     32     34     66  
Netherlands     17     18     35  
Spain     33     26     59  
Sweden     9     8     17  
Switzerland     12     10     22  
Turkey     14     14     28  
United Kingdom     18     21     39  



  Outcome Measures
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1.  Primary:   Percentage of Participants Who Achieve a PASI75 Response at Week 16 Compared With Baseline (Week 0)   [ Time Frame: Week 0 and Week 16 ]
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2.  Secondary:   Percentage of Participants With a PASI50 Response at Week 16 Compared With Baseline (Week 0)   [ Time Frame: Week 0 and Week 16 ]
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3.  Secondary:   Percentage of Participants With a PASI90 Response at Week 16 Compared With Baseline (Week 0)   [ Time Frame: Week 0 and Week 16 ]
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4.  Secondary:   Percentage of Participants With a PASI100 Response at Week 16 Compared With Baseline (Week 0)   [ Time Frame: Week 0 and Week 16 ]
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5.  Secondary:   Percentage of Participants Achieving a Physician's Global Assessment (PGA) of Clear or Minimal at Week 2   [ Time Frame: Week 2 ]
  Show Outcome Measure 5

6.  Secondary:   Percentage of Participants Achieving a Physician's Global Assessment (PGA) of Clear or Minimal at Week 4   [ Time Frame: Week 4 ]
  Show Outcome Measure 6

7.  Secondary:   Percentage of Participants Achieving a Physician's Global Assessment (PGA) of Clear or Minimal at Week 8   [ Time Frame: Week 8 ]
  Show Outcome Measure 7

8.  Secondary:   Percentage of Participants Achieving a Physician's Global Assessment (PGA) of Clear or Minimal at Week 12   [ Time Frame: Week 12 ]
  Show Outcome Measure 8

9.  Secondary:   Percentage of Participants Achieving a Physicians Global Assessment (PGA) Response of Clear or Minimal at Week 16   [ Time Frame: Week 16 ]
  Show Outcome Measure 9

10.  Secondary:   Percent Change From Baseline in the Dermatology Life Quality Index (DLQI) Total Score at Week 16 Compared With Baseline (Week 0)   [ Time Frame: Week 0 and Week 16 ]
  Show Outcome Measure 10

11.  Secondary:   Percent Change in the Dermatology Life Quality Index (DLQI) Total Score at Week 2 Compared With Baseline (Week 0)   [ Time Frame: Week 0 and Week 2 ]
  Show Outcome Measure 11

12.  Secondary:   Percent Change From Baseline in the Dermatology Life Quality Index (DLQI) Total Score at Week 4 Compared With Baseline (Week 0)   [ Time Frame: Week 0 and Week 4 ]
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13.  Secondary:   Percent Change From Baseline in the Dermatology Life Quality Index (DLQI) Total Score at Week 8 Compared With Baseline (Week 0)   [ Time Frame: Week 0 and Week 8 ]
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14.  Secondary:   Percent Change From Baseline in the Dermatology Life Quality Index (DLQI) Total Score at Week 12 Compared With Baseline (Week 0)   [ Time Frame: Week 0 and Week 12 ]
  Show Outcome Measure 14

15.  Secondary:   Percent Change in Short Form 36 Health Survey (SF-36) Physical Component Score (PCS) at Week 16 Compared With Baseline (Week 0)   [ Time Frame: Week 0 and Week 16 ]
  Show Outcome Measure 15

16.  Secondary:   Percent Change in Short Form 36 Health Survey (SF-36) Physical Component Score (PCS) at Week 8 Compared With Baseline (Week 0)   [ Time Frame: Week 0 and Week 8 ]
  Show Outcome Measure 16

17.  Other Pre-specified:   Percent Change in Psoriasis Scalp Severity Index (PSSI) From Baseline to Week 16.   [ Time Frame: Week 0 and Week 16 ]
  Show Outcome Measure 17

18.  Other Pre-specified:   Percent Change in Nail Psoriasis Severity Index (NAPSI) at Week 16.   [ Time Frame: Week 0 and Week 16 ]
  Show Outcome Measure 18


  Serious Adverse Events
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  Other Adverse Events
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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.


Limitations and Caveats
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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Results Point of Contact:  
Name/Title: Medical Information Specialist
Organization: Abbott
phone: 1-800-633-9110


No publications provided


Responsible Party: Marie Rosenfeld, Senior CRM, Abbott
ClinicalTrials.gov Identifier: NCT00574249     History of Changes
Other Study ID Numbers: M10-060
Study First Received: December 12, 2007
Results First Received: October 29, 2009
Last Updated: April 11, 2011
Health Authority: Turkey: Ethics Committee





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