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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
Enrollment 85
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Group A Group B Groupe A Dose Increase at Week 12 Groupe B Dose Increase at Week 12
Hide Arm/Group Description Patients who have shown an unsatisfactory response to 3 months of etanercept wihout dose reduction prior to screening. 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. 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. 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.
Period Title: Week 0 to Week 12
Started 50 35 0 0
Completed 49 34 0 0
Not Completed 1 1 0 0
Reason Not Completed
Worsening of psoriasis             1             1             0             0
Period Title: Week 12 to Week 24
Started 18 [1] 11 [2] 31 [3] 23 [4]
Completed 16 11 28 20
Not Completed 2 0 3 3
Reason Not Completed
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
Arm/Group Title Group A Group B Total
Hide Arm/Group Description Patients who have shown an unsatisfactory response to 3 months of etanercept wihout dose reduction prior to screening. 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 of all reporting groups
Overall Number of Baseline Participants 50 35 85
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 50 participants 35 participants 85 participants
<=18 years
0
   0.0%
0
   0.0%
0
   0.0%
Between 18 and 65 years
47
  94.0%
32
  91.4%
79
  92.9%
>=65 years
3
   6.0%
3
   8.6%
6
   7.1%
Age Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 50 participants 35 participants 85 participants
49.12  (11.18) 46.17  (11.2) 47.91  (11.21)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 50 participants 35 participants 85 participants
Female
14
  28.0%
11
  31.4%
25
  29.4%
Male
36
  72.0%
24
  68.6%
60
  70.6%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
Canada Number Analyzed 50 participants 35 participants 85 participants
50 35 85
1.Primary Outcome
Title Number of Patients From Group B Who Achieve a Physician's Global Assessment (PGA) of Clear or Almost Clear at Week 12.
Hide Description

Efficacy of adalimumab 40 mg every other week in patients in Group B by calculating the number of patients who achieve a PGA of clear or almost clear at Week 12.

Clear is defined by no plaque elevation above normal skin. There is no scale. Erythema is perceptible as hyperpigmentation, pigmented macules, diffuse faint pink or red coloration.

Almost Clear is defined as follows: It is possible but difficult to ascertain whether there is a slight elevation above normal skin. There is scaling in the form of surface dryness with some white coloration. Erythema is up to a difinite red coloration.

Time Frame 12 weeks
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
The analysis was intent to treat (ITT) and inputed Last observation carried forward (LOCF)
Arm/Group Title Group B
Hide Arm/Group Description:
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.
Overall Number of Participants Analyzed 35
Measure Type: Number
Unit of Measure: Participants
11
2.Secondary Outcome
Title Number of Patients From Group A Who Achieve a Physician's Global Assessment (PGA) of Clear or Almost Clear at Week 12.
Hide Description

Efficacy of adalimumab in patients from Group A who achieve a Physician's Global Assessment (PGA) of clear or almost clear at week 12.

Clear is defined by no plaque elevation above normal skin. There is no scale. Erythema is perceptible as hyperpigmentation, pigmented macules, diffuse faint pink or red coloration.

Almost Clear is defined as follows: It is possible but difficult to ascertain whether there is a slight elevation above normal skin. There is scaling in the form of surface dryness with some white coloration. Erythema is up to a difinite red coloration.

Time Frame 12 weeks
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
The analysis was intent to treat (ITT) and inputed Last observation carried forward (LOCF)
Arm/Group Title Group A
Hide Arm/Group Description:
Patients who have shown an unsatisfactory response to 3 months of etanercept wihout dose reduction prior to screening.
Overall Number of Participants Analyzed 50
Measure Type: Number
Unit of Measure: Participants
17
3.Secondary Outcome
Title 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.
Hide Description

Efficacy of adalimumab in patients from Group B who achieve a Physician's global assessment (PGA) of clear or almost clear at Week 24.

Clear is defined by no plaque elevation above normal skin. There is no scale. Erythema is perceptible as hyperpigmentation, pigmented macules, diffuse faint pink or red coloration.

Almost Clear is defined as follows: It is possible but difficult to ascertain whether there is a slight elevation above normal skin. There is scaling in the form of surface dryness with some white coloration. Erythema is up to a difinite red coloration.

Time Frame 24 weeks
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
The analysis was intent to treat (ITT) and inputed Last observation carried forward (LOCF)
Arm/Group Title Groupe B Dose Increase at Week 12
Hide Arm/Group Description:
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.
Overall Number of Participants Analyzed 23
Measure Type: Number
Unit of Measure: Participants
7
4.Secondary Outcome
Title 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.
Hide Description

Efficacy of adalimumab in patients from Group A who achieve a Physician's Global Assessment (PGA) of clear or almost clear at Week 24.

Clear is defined by no plaque elevation above normal skin. There is no scale. Erythema is perceptible as hyperpigmentation, pigmented macules, diffuse faint pink or red coloration.

Almost Clear is defined as follows: It is possible but difficult to ascertain whether there is a slight elevation above normal skin. There is scaling in the form of surface dryness with some white coloration. Erythema is up to a difinite red coloration.

Time Frame 24 weeks
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
The analysis was intent to treat (ITT) and inputed Last observation carried forward (LOCF)
Arm/Group Title Groupe A Dose Increase at Week 12
Hide Arm/Group Description:
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.
Overall Number of Participants Analyzed 31
Measure Type: Number
Unit of Measure: Participants
10
5.Secondary Outcome
Title Total Number of Adverse Events for All Patients in the Study.
Hide Description Safety of adalimumab in patients with plaque psoriasis that showed an unsatisfactory response after at least 3 months of therapy with etanercept
Time Frame 24 weeks
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
The analysis was intent to treat (ITT) and inputed Last observation carried forward (LOCF)
Arm/Group Title Group A Group B
Hide Arm/Group Description:
Patients at screening had shown an unsastifactory response after 3 months of etanercept 50mg twice a week.
Patients at screening had shown a satisfactory response to etanercept 50mg twice a week followed by a loss of response after dose reduction to 50mg etanercept once a week.
Overall Number of Participants Analyzed 50 35
Measure Type: Number
Unit of Measure: Adverse events
91 63
Time Frame The period in which adverse events were recorded was between the signing of the informed consent at screening and Week 28 (approximately 32 weeks).
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Group A Group B
Hide Arm/Group Description Patients who have shown an unsatisfactory response to 3 months of etanercept 50 mg twice a week without dose reduction prior to screening. 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.
All-Cause Mortality
Group A Group B
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--      --/--    
Show Serious Adverse Events Hide Serious Adverse Events
Group A Group B
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   0/50 (0.00%)      0/35 (0.00%)    
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Group A Group B
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   20/50 (40.00%)      8/35 (22.86%)    
Infections and infestations     
Common Cold *  4/50 (8.00%)  5 2/35 (5.71%)  2
Upper Respiratory Tract Infection *  9/50 (18.00%)  12 2/35 (5.71%)  3
Sinusitis *  3/50 (6.00%)  3 0/35 (0.00%)  0
Musculoskeletal and connective tissue disorders     
Back Pain *  4/50 (8.00%)  7 0/35 (0.00%)  0
Nervous system disorders     
Headache *  0/50 (0.00%)  0 4/35 (11.43%)  4
*
Indicates events were collected by non-systematic assessment
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
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