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Safety and Efficacy of Adalimumab in Patients Who Showed an Unsatisfactory Response to Etanercept

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ClinicalTrials.gov Identifier: NCT00927069
Recruitment Status : Completed
First Posted : June 24, 2009
Results First Posted : August 24, 2010
Last Update Posted : September 9, 2011
Sponsor:
Collaborator:
Abbott
Information provided by (Responsible Party):
Innovaderm Research Inc.

Study Type: Interventional
Study Design: Allocation: Non-Randomized;   Intervention Model: Parallel Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition: Plaque Psoriasis
Interventions: Drug: Adalimumab every other week
Drug: Adalimumab Every Week

  Participant Flow

Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
No text entered.

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
Group A Patients who have shown an unsatisfactory response to 3 months of etanercept wihout dose reduction prior to screening.
Group B Patients who showed a satisfactory response to 3 months or more of etanercept 50 mg twice a week followed by a loss of response after dose reduction to 50 mg etanercept once a week prior to screening.
Groupe A Dose Increase at Week 12 Patients in group A who - after 12 weeks of adalimimab 40 mg every other week in this study - failed to acheive a PGA of clear or almost clear and had a dose increase to 40 mg adalimimab every week for another 12 weeks.
Groupe B Dose Increase at Week 12 Patients in group B who - after 12 weeks of adalimimab 40 mg every other week in this study - failed to acheive a PGA of clear or almost clear and had a dose increase to 40 mg adalimimab every week for another 12 weeks.

Participant Flow for 2 periods

Period 1:   Week 0 to Week 12
    Group A   Group B   Groupe A Dose Increase at Week 12   Groupe B Dose Increase at Week 12
STARTED   50   35   0   0 
COMPLETED   49   34   0   0 
NOT COMPLETED   1   1   0   0 
Worsening of psoriasis                1                1                0                0 

Period 2:   Week 12 to Week 24
    Group A   Group B   Groupe A Dose Increase at Week 12   Groupe B Dose Increase at Week 12
STARTED   18 [1]   11 [2]   31 [3]   23 [4] 
COMPLETED   16   11   28   20 
NOT COMPLETED   2   0   3   3 
Lack of Efficacy                0                0                2                3 
Lost to Follow-up                0                0                1                0 
Withdrawal by Subject                1                0                0                0 
Had a vaccination, removed from study                1                0                0                0 
[1] 17 patients stayed at the same dose. One patient withdrew at Week 12 and also had no dose increase
[2] 11 patients stayed at the same dose of 40 mg Adalimumab every other week
[3] 31 Pts. from Group A had a dose incr. since they did not respond to 40mg adalimumab every other week
[4] 23 Pts. from Group B had a dose incr. since they did not respond to 40mg adalimumab every other week



  Baseline Characteristics

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
Group A Patients who have shown an unsatisfactory response to 3 months of etanercept wihout dose reduction prior to screening.
Group B Patients who showed a satisfactory response to 3 months or more of etanercept 50 mg twice a week followed by a loss of response after dose reduction to 50 mg etanercept once a week prior to screening.
Total Total of all reporting groups

Baseline Measures
   Group A   Group B   Total 
Overall Participants Analyzed 
[Units: Participants]
 50   35   85 
Age 
[Units: Participants]
     
<=18 years   0   0   0 
Between 18 and 65 years   47   32   79 
>=65 years   3   3   6 
Age 
[Units: Years]
Mean (Standard Deviation)
 49.12  (11.18)   46.17  (11.2)   47.91  (11.21) 
Gender 
[Units: Participants]
     
Female   14   11   25 
Male   36   24   60 
Region of Enrollment 
[Units: Participants]
     
Canada   50   35   85 


  Outcome Measures

1.  Primary:   Number of Patients From Group B Who Achieve a Physician's Global Assessment (PGA) of Clear or Almost Clear at Week 12.   [ Time Frame: 12 weeks ]

2.  Secondary:   Number of Patients From Group A Who Achieve a Physician's Global Assessment (PGA) of Clear or Almost Clear at Week 12.   [ Time Frame: 12 weeks ]

3.  Secondary:   Number of Patients From Group B Who Achieve a Physician's Global Assessment (PGA) of Clear or Almost Clear at Week 24 After a Dose Increase to 40mg Adalimumab Every Week.   [ Time Frame: 24 weeks ]

4.  Secondary:   Number of Patients From Group A Who Achieve a Physician's Global Assessment (PGA) of Clear or Almost Clear at Week 24 After a Dose Increase to 40mg Adalimumab Every Week.   [ Time Frame: 24 weeks ]

5.  Secondary:   Total Number of Adverse Events for All Patients in the Study.   [ Time Frame: 24 weeks ]


  Serious Adverse Events


  Other Adverse Events


  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
This was an open label uncontrolled study.


  More Information

Certain Agreements:  
All Principal Investigators ARE employed by the organization sponsoring the study.


Results Point of Contact:  
Name/Title: Annie Levesque
Organization: Innovaderm Research, Inc.
phone: 514 521 4285 ext 222
e-mail: alevesque@innovaderm.ca



Responsible Party: Innovaderm Research Inc.
ClinicalTrials.gov Identifier: NCT00927069     History of Changes
Other Study ID Numbers: Inno-6002
First Submitted: June 22, 2009
First Posted: June 24, 2009
Results First Submitted: January 18, 2010
Results First Posted: August 24, 2010
Last Update Posted: September 9, 2011