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CompletedNCT00992394ReSPONSEUpdated Jan 8, 2016Results posted

Study Comparing 2 Different Strategies For Management of Subjects With Plaque Psoriasis Who Have Responded to Etanercept

A Phase 4 interventional study of etanercept and etanercept in Psoriasis, sponsored by Pfizer. Completed at 46 sites in 9 countries. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2016-01-08.

Sponsored by Pfizer · Phase 4, Interventional, and Treatment

Phase
Phase 4
Study type
Interventional
Enrollment
174
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Study summary

This study proposes to compare 2 different methods for managing a subject with psoriasis who has achieved good disease control, as defined by a clinical response with a Physician Global Assessment (PGA) inferior or equal to 1 at the screening visit, on etanercept treatment.

The first method involves stopping etanercept treatment on entry into the study, with the option to reinitiate etanercept at 50 mg once weekly after medical review and agreement between the subject and the investigator. The second method involves continuing on etanercept at 25 mg once weekly, with the option to increase the dose to 50 mg once weekly after medical review and agreement between the subject and the investigator. Subjects will be randomized into one of these two study arms.

02

Conditions studied

  • Psoriasis

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Keywords

  • Plaque psoriasis - etanercept - response maintenance
03

In context

Psoriasis

1,899 studies on the registry are indexed under Psoriasis; 233 are open to participants now.

This study's enrollment of 174 is above the median of 70 across 1,447 interventional studies indexed under Psoriasis.

Browse Psoriasis studies →

Lead sponsor

Pfizer is the lead sponsor of 3,244 studies on the registry; 139 are open to participants now.

Of its 582 completed or terminated interventional studies of FDA-regulated products, 381 (65%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  • Eighteen (18) years of age or older at the time of consent.
  • Previously treated with etanercept for chronic plaque psoriasis for at least 12 weeks prior to the screening visit and received a total weekly dose of 50 mg per week for at least the 6 weeks preceding the day of the screening visit
  • Having shown clinical response with a PGA inferior or equal to 1 at the screening visit.
  • PGA inferior or equal to 1 at the baseline visit.

Exclusion criteria

Exclusion Criteria:

  • Evidence of skin conditions (eg, eczema) other than psoriasis that would interfere with evaluations of the effect of study medication on psoriasis.
  • Evidence of active or previously known medical history of inflammatory arthritis (eg, rheumatoid arthritis, psoriatic arthritis, ankylosing spondylitis).
  • Any biologics other than etanercept within the 20 weeks prior to the screening visit.
05

Study design

Phase
Phase 4
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
174 participants (actual)

Study arms

  • Other
    Arm 1

    Subjects randomized to arm 1 stop their etanercept treatment on entry into the study and may be retreated by etanercept 50 mg once weekly after medical review and agreement between the subject and the investigator

    Drug: etanercept

  • Other
    Arm 2

    Subjects randomized to arm 2 in which subjects continue on treatment with etanercept at 25 mg once weekly, but with the option to have their drug treatment increased to 50 mg once weekly after medical review and agreement between the subject and the investigator

    Drug: etanercept

Interventions

  • Drugetanercept

    etanercept 50 mg once weekly as requested.

  • Drugetanercept

    etanercept 25 mg or 50 mg as requested.

06

What researchers measure

Primary outcomes

  1. Time-Normalized Area Under Curve (AUC) of Physician Global Assessment (PGA) of Psoriasis Score at Week 52

    PGA psoriasis is scored on a 5-point scale, reflecting a global consideration of the erythema, induration and scaling across all psoriatic lesions. PGA of Psoriasis scale ranges from 0 (no psoriasis) to 5 (severe disease). 'Clear' and "Almost clear' includes all participants who were scored as a 0 or 1. For participants who discontinued the study before week 52, the final PGA score was carried forward to the remaining time points before calculating the 52-week AUC. The AUC was calculated on the PGA score profile with the method of trapeziums from baseline visit to visit 52. The time-normalized AUC is defined as the ratio between AUC and the expected treatment period (days): AUC/ 52 weeks\*7days + 1.

    Time frame: Week 52

Secondary outcomes

  1. Time-Normalized Area Under Curve (AUC) of Dermatology Life Quality Index (DLQI) at Week 52

    DLQI is the dermatology-specific quality of life measure used for psoriatic population. The 10-item questionnaire has a score range of 0 to 30 with higher scores indicating poor quality of life. An estimate of the minimal clinically important difference of the DLQI total score is a 5 point improvement. Total score range: 0 (best) to 30 (worst).

    Time frame: Week 52

  2. Patient Psoriasis Satisfaction Questionnaire (PSSQ): The Overall Appearance of Skin, at Baseline, Before Retreatment, and at the End of Retreatment

    Participants completed a satisfaction survey at baseline and throughout the study. Participants were asked to rate, based on their experience during the past week, how satisfied or dissatisfied they were with their psoriasis therapy in general. Responses were based on a 5-point scale: Very dissatisfied (0) to very satisfied (4), and never had this problem (5).

    Time frame: Baseline to Week 52

  3. Patient Psoriasis Satisfaction Questionnaire (PSSQ): Flaking Skin, at Baseline, Before Retreatment, and at the End of Retreatment

    Participants completed a satisfaction survey at baseline and throughout the study. Participants were asked to rate, based on their experience during the past week, how satisfied or dissatisfied they were with their psoriasis therapy in general. Responses were based on a 5-point scale: Very dissatisfied (0) to very satisfied (4), and never had this problem (5).

    Time frame: Baseline to Week 52

  4. Patient Psoriasis Satisfaction Questionnaire (PSSQ): Redness of the Skin, at Baseline, Before Retreatment, and at the End of Retreatment

    Participants completed a satisfaction survey at baseline and throughout the study. Participants were asked to rate, based on their experience during the past week, how satisfied or dissatisfied they were with their psoriasis therapy in general. Responses were based on a 5-point scale: Very dissatisfied (0) to very satisfied (4), and never had this problem (5).

    Time frame: Baseline to Week 52

  5. Patient Psoriasis Satisfaction Questionnaire (PSSQ): Tightness of the Skin, at Baseline, Before Retreatment, and at the End of Retreatment

    Participants completed a satisfaction survey at baseline and throughout the study. Participants were asked to rate, based on their experience during the past week, how satisfied or dissatisfied they were with their psoriasis therapy in general. Responses were based on a 5-point scale: Very dissatisfied (0) to very satisfied (4), and never had this problem (5).

    Time frame: Baseline to Week 52

  6. Patient Psoriasis Satisfaction Questionnaire (PSSQ): Bleeding of the Skin, at Baseline, Before Retreatment, and at the End of Retreatment

    Participants completed a satisfaction survey at baseline and throughout the study. Participants were asked to rate, based on their experience during the past week, how satisfied or dissatisfied they were with their psoriasis therapy in general. Responses were based on a 5-point scale: Very dissatisfied (0) to very satisfied (4), and never had this problem (5).

    Time frame: Baseline to Week 52

  7. Patient Psoriasis Satisfaction Questionnaire (PSSQ): Burning Sensation in the Skin, at Baseline, Before Retreatment, and at the End of Retreatment

    Participants completed a satisfaction survey at baseline and throughout the study. Participants were asked to rate, based on their experience during the past week, how satisfied or dissatisfied they were with their psoriasis therapy in general. Responses were based on a 5-point scale: Very dissatisfied (0) to very satisfied (4), and never had this problem (5).

    Time frame: Baseline to Week 52

  8. Patient Psoriasis Satisfaction Questionnaire (PSSQ): Skin Pain, at Baseline, Before Retreatment, and at the End of Retreatment

    Participants completed a satisfaction survey at baseline and throughout the study. Participants were asked to rate, based on their experience during the past week, how satisfied or dissatisfied they were with their psoriasis therapy in general. Responses were based on a 5-point scale: Very dissatisfied (0) to very satisfied (4), and never had this problem (5).

    Time frame: Baseline to Week 52

  9. Patient Psoriasis Satisfaction Questionnaire (PSSQ): Joint Pain, at Baseline, Before Retreatment, and at the End of Retreatment

    Participants completed a satisfaction survey at baseline and throughout the study. Participants were asked to rate, based on their experience during the past week, how satisfied or dissatisfied they were with their psoriasis therapy in general. Responses were based on a 5-point scale: Very dissatisfied (0) to very satisfied (4), and never had this problem (5).

    Time frame: Baseline to Week 52

  10. Patient Psoriasis Satisfaction Questionnaire (PSSQ): Your Comfort Level With Your Personal Appearance, at Baseline, Before Retreatment, and at the End of Retreatment

    Participants completed a satisfaction survey at baseline and throughout the study. Participants were asked to rate, based on their experience during the past week, how satisfied or dissatisfied they were with their psoriasis therapy in general. Responses were based on a 5-point scale: Very dissatisfied (0) to very satisfied (4), and never had this problem (5).

    Time frame: Baseline to Week 52

  11. Patient Psoriasis Satisfaction Questionnaire (PSSQ): Anxiety, at Baseline, Before Retreatment, and at the End of Retreatment

    Participants completed a satisfaction survey at baseline and throughout the study. Participants were asked to rate, based on their experience during the past week, how satisfied or dissatisfied they were with their psoriasis therapy in general. Responses were based on a 5-point scale: Very dissatisfied (0) to very satisfied (4), and never had this problem (5).

    Time frame: Baseline to Week 52

  12. Patient Psoriasis Satisfaction Questionnaire (PSSQ): Depression, at Baseline, Before Retreatment, and at the End of Retreatment

    Participants completed a satisfaction survey at baseline and throughout the study. Participants were asked to rate, based on their experience during the past week, how satisfied or dissatisfied they were with their psoriasis therapy in general. Responses were based on a 5-point scale: Very dissatisfied (0) to very satisfied (4), and never had this problem (5).

    Time frame: Baseline to Week 52

  13. Patient Psoriasis Satisfaction Questionnaire (PSSQ): Fatigue, at Baseline, Before Retreatment, and at the End of Retreatment

    Participants completed a satisfaction survey at baseline and throughout the study. Participants were asked to rate, based on their experience during the past week, how satisfied or dissatisfied they were with their psoriasis therapy in general. Responses were based on a 5-point scale: Very dissatisfied (0) to very satisfied (4), and never had this problem (5).

    Time frame: Baseline to Week 52

  14. Patient Psoriasis Satisfaction Questionnaire (PSSQ): How Others Respond to Your Personal Appearance at Work/School, at Baseline, Before Retreatment, and at the End of Retreatment

    Participants completed a satisfaction survey at baseline and throughout the study. Participants were asked to rate, based on their experience during the past week, how satisfied or dissatisfied they were with their psoriasis therapy in general. Responses were based on a 5-point scale: Very dissatisfied (0) to very satisfied (4), and never had this problem (5).

    Time frame: Baseline to Week 52

  15. Patient Psoriasis Satisfaction Questionnaire (PSSQ): How Your Skin Affects Your Social and Leisure Activities, at Baseline, Before Retreatment, and at the End of Retreatment

    Participants completed a satisfaction survey at baseline and throughout the study. Participants were asked to rate, based on their experience during the past week, how satisfied or dissatisfied they were with their psoriasis therapy in general. Responses were based on a 5-point scale: Very dissatisfied (0) to very satisfied (4), and never had this problem (5).

    Time frame: Baseline to Week 52

  16. Patient Psoriasis Satisfaction Questionnaire (PSSQ): How Satisfied Were You With Your Psoriasis Treatment in General? at Baseline, Before Retreatment, and at the End of Retreatment

    Participants completed a satisfaction survey at baseline and throughout the study. Participants were asked to rate, based on their experience during the past week, how satisfied or dissatisfied they were with their psoriasis therapy in general. Responses were based on a 5-point scale: Very dissatisfied (0) to very satisfied (4), and never had this problem (5).

    Time frame: Baseline to Week 52

  17. Patient Psoriasis Satisfaction Questionnaire (PSSQ): I Would Like to Continue With my Current Psoriasis Treatment, at Baseline, Before Retreatment, and at the End of Retreatment

    Participants completed a satisfaction survey at baseline and throughout the study. Participants were asked to rate, based on their experience during the past week, how satisfied or dissatisfied they were with their psoriasis therapy in general. Responses were based on a 5-point scale: Very dissatisfied (0) to very satisfied (4), and never had this problem (5).

    Time frame: Baseline to Week 52

  18. Physician Global Assessment (PGA) of Disease Activity at Week 52

    Participants completed a satisfaction survey at baseline and throughout the study. Participants were asked to rate, based on their experience during the past week, how satisfied or dissatisfied they were with their psoriasis therapy in general. Responses were based on a 5-point scale: Very dissatisfied (0) to very satisfied (4), and never had this problem (5).

    Time frame: Week 52

07

Results

Posted Jan 8, 2016
Limitations and caveats
Enrollment in this study was slower than expected. Thus, recruitment was terminated early and only 58 percent of planned participants were randomized. As a result, no hypothesis testing was conducted and only descriptive statistics are reported.

Participant flow

This multicenter open label, randomized study screened 209 participants in 44 sites.

Participant flow — Overall Study
MilestoneStop ArmMaintenance Arm
Started8886
Safety population8784
Mitt population8684
Completed6472
Not completed2414
Withdrew: Lack of efficacy63
Withdrew: Adverse event45
Withdrew: Withdrawal by subject82
Withdrew: Physician decision10
Withdrew: Protocol violation24
Withdrew: Lost to follow-up20
Withdrew: Other event10

Outcome measures

PrimaryTime-Normalized Area Under Curve (AUC) of Physician Global Assessment (PGA) of Psoriasis Score at Week 52

PGA psoriasis is scored on a 5-point scale, reflecting a global consideration of the erythema, induration and scaling across all psoriatic lesions. PGA of Psoriasis scale ranges from 0 (no psoriasis) to 5 (severe disease). 'Clear' and "Almost clear' includes all participants who were scored as a 0 or 1. For participants who discontinued the study before week 52, the final PGA score was carried forward to the remaining time points before calculating the 52-week AUC. The AUC was calculated on the PGA score profile with the method of trapeziums from baseline visit to visit 52. The time-normalized AUC is defined as the ratio between AUC and the expected treatment period (days): AUC/ 52 weeks\*7days + 1.

Time frame:
Week 52
Reported as:
Mean · Units on a scale
Time-Normalized Area Under Curve (AUC) of Physician Global Assessment (PGA) of Psoriasis Score at Week 52
Units on a scaleStop ArmMaintenance Arm
Time-Normalized Area Under Curve (AUC) of Physician Global Assessment (PGA) of Psoriasis Score at Week 521.64 ± 0.751.33 ± 0.76
SecondaryTime-Normalized Area Under Curve (AUC) of Dermatology Life Quality Index (DLQI) at Week 52

DLQI is the dermatology-specific quality of life measure used for psoriatic population. The 10-item questionnaire has a score range of 0 to 30 with higher scores indicating poor quality of life. An estimate of the minimal clinically important difference of the DLQI total score is a 5 point improvement. Total score range: 0 (best) to 30 (worst).

Time frame:
Week 52
Reported as:
Mean · Units on a scale
Time-Normalized Area Under Curve (AUC) of Dermatology Life Quality Index (DLQI) at Week 52
Units on a scaleStop ArmMaintenance Arm
Time-Normalized Area Under Curve (AUC) of Dermatology Life Quality Index (DLQI) at Week 524.07 ± 4.212.96 ± 3.23
SecondaryPatient Psoriasis Satisfaction Questionnaire (PSSQ): The Overall Appearance of Skin, at Baseline, Before Retreatment, and at the End of Retreatment

Participants completed a satisfaction survey at baseline and throughout the study. Participants were asked to rate, based on their experience during the past week, how satisfied or dissatisfied they were with their psoriasis therapy in general. Responses were based on a 5-point scale: Very dissatisfied (0) to very satisfied (4), and never had this problem (5).

Time frame:
Baseline to Week 52
Reported as:
Number · Number of participants
Patient Psoriasis Satisfaction Questionnaire (PSSQ): The Overall Appearance of Skin, at Baseline, Before Retreatment, and at the End of Retreatment
Number of participantsStop ArmMaintenance Arm
Baseline, Subjects Satisfied6667
Prior to Re-treatment, Cycle 1155
End of Re-treatment, Cycle 13112
Prior to Re-treatment, Cycle 251
End of re-treatment, Cycle 2102
SecondaryPatient Psoriasis Satisfaction Questionnaire (PSSQ): Flaking Skin, at Baseline, Before Retreatment, and at the End of Retreatment

Participants completed a satisfaction survey at baseline and throughout the study. Participants were asked to rate, based on their experience during the past week, how satisfied or dissatisfied they were with their psoriasis therapy in general. Responses were based on a 5-point scale: Very dissatisfied (0) to very satisfied (4), and never had this problem (5).

Time frame:
Baseline to Week 52
Reported as:
Number · Number of Participants
Patient Psoriasis Satisfaction Questionnaire (PSSQ): Flaking Skin, at Baseline, Before Retreatment, and at the End of Retreatment
Number of ParticipantsStop ArmMaintenance Arm
Baseline, Subjects Satisfied6059
Prior to Re-treatment, Cycle 1, Satisfied124
End of Re-treatment, Cycle 1, satisfied2611
Prior to Re-treatment, Cycle, 2, Satisfied51
End of Re-treatment, Cycle 2, Satisfied82
SecondaryPatient Psoriasis Satisfaction Questionnaire (PSSQ): Redness of the Skin, at Baseline, Before Retreatment, and at the End of Retreatment

Participants completed a satisfaction survey at baseline and throughout the study. Participants were asked to rate, based on their experience during the past week, how satisfied or dissatisfied they were with their psoriasis therapy in general. Responses were based on a 5-point scale: Very dissatisfied (0) to very satisfied (4), and never had this problem (5).

Time frame:
Baseline to Week 52
Reported as:
Number · Number of Participants
Patient Psoriasis Satisfaction Questionnaire (PSSQ): Redness of the Skin, at Baseline, Before Retreatment, and at the End of Retreatment
Number of ParticipantsStop ArmMaintenance Arm
Baseline, Subjects Satisfied6259
Prior to Re-treatment, Cycle 1, Satisfied144
End of Re-treatment, Cycle 1, Satisfied2710
Prior to Re-treatment, Cycle 2, Satisfied41
End of Re-treatment, Cycle 2, Satisfied82
SecondaryPatient Psoriasis Satisfaction Questionnaire (PSSQ): Tightness of the Skin, at Baseline, Before Retreatment, and at the End of Retreatment

Participants completed a satisfaction survey at baseline and throughout the study. Participants were asked to rate, based on their experience during the past week, how satisfied or dissatisfied they were with their psoriasis therapy in general. Responses were based on a 5-point scale: Very dissatisfied (0) to very satisfied (4), and never had this problem (5).

Time frame:
Baseline to Week 52
Reported as:
Number · Number of Participants
Patient Psoriasis Satisfaction Questionnaire (PSSQ): Tightness of the Skin, at Baseline, Before Retreatment, and at the End of Retreatment
Number of ParticipantsStop ArmMaintenance Arm
Baseline, Subjects Satisfied6154
Prior to Re-treatment, Cycle 1, Satisfied175
End of Re-treatment, Cycle 1, Satisfied309
Prior to Re-treatment, Cycle 2, Satisfied62
End of Re-treatment, Cycle 2, Satisfied100
SecondaryPatient Psoriasis Satisfaction Questionnaire (PSSQ): Bleeding of the Skin, at Baseline, Before Retreatment, and at the End of Retreatment

Participants completed a satisfaction survey at baseline and throughout the study. Participants were asked to rate, based on their experience during the past week, how satisfied or dissatisfied they were with their psoriasis therapy in general. Responses were based on a 5-point scale: Very dissatisfied (0) to very satisfied (4), and never had this problem (5).

Time frame:
Baseline to Week 52
Reported as:
Number · Number of Participants
Patient Psoriasis Satisfaction Questionnaire (PSSQ): Bleeding of the Skin, at Baseline, Before Retreatment, and at the End of Retreatment
Number of ParticipantsStop ArmMaintenance Arm
Baseline, Subjects Satisfied4537
Prior to Re-treatment, Cycle 1, Satisfied1711
End of Re-treatment, Cycle 1, Satisfied2210
Prior to Re-treatment, Cycle 2, Satisfied72
End of Re-treatment, Cycle 2, Satisfied102
SecondaryPatient Psoriasis Satisfaction Questionnaire (PSSQ): Burning Sensation in the Skin, at Baseline, Before Retreatment, and at the End of Retreatment

Participants completed a satisfaction survey at baseline and throughout the study. Participants were asked to rate, based on their experience during the past week, how satisfied or dissatisfied they were with their psoriasis therapy in general. Responses were based on a 5-point scale: Very dissatisfied (0) to very satisfied (4), and never had this problem (5).

Time frame:
Baseline to Week 52
Reported as:
Number · Number of Participants
Patient Psoriasis Satisfaction Questionnaire (PSSQ): Burning Sensation in the Skin, at Baseline, Before Retreatment, and at the End of Retreatment
Number of ParticipantsStop ArmMaintenance Arm
Baseline, Subjects Satisfied5139
Prior to Re-treatment, Cycle 1, Satisfied146
End of Re-treatment, Cycle 1, Satisfied238
Prior to Re-treatment, Cycle 2, Satisfied41
End of Re-treatment, Cycle 2, Satisfied102
SecondaryPatient Psoriasis Satisfaction Questionnaire (PSSQ): Skin Pain, at Baseline, Before Retreatment, and at the End of Retreatment

Participants completed a satisfaction survey at baseline and throughout the study. Participants were asked to rate, based on their experience during the past week, how satisfied or dissatisfied they were with their psoriasis therapy in general. Responses were based on a 5-point scale: Very dissatisfied (0) to very satisfied (4), and never had this problem (5).

Time frame:
Baseline to Week 52
Reported as:
Number · Number of Participants
Patient Psoriasis Satisfaction Questionnaire (PSSQ): Skin Pain, at Baseline, Before Retreatment, and at the End of Retreatment
Number of ParticipantsStop ArmMaintenance Arm
Baseline, Subjects Satisfied4744
Prior to Re-treatment, Cycle 1, Satisfied137
End of Re-treatment, Cycle 1, Satisfied248
Prior to Re-treatment, Cycle 2, Satisfied51
End of Re-treatment, Cycle 2, Satisfied91
SecondaryPatient Psoriasis Satisfaction Questionnaire (PSSQ): Joint Pain, at Baseline, Before Retreatment, and at the End of Retreatment

Participants completed a satisfaction survey at baseline and throughout the study. Participants were asked to rate, based on their experience during the past week, how satisfied or dissatisfied they were with their psoriasis therapy in general. Responses were based on a 5-point scale: Very dissatisfied (0) to very satisfied (4), and never had this problem (5).

Time frame:
Baseline to Week 52
Reported as:
Number · Number of Participants
Patient Psoriasis Satisfaction Questionnaire (PSSQ): Joint Pain, at Baseline, Before Retreatment, and at the End of Retreatment
Number of ParticipantsStop ArmMaintenance Arm
Baseline, Subjects Satisfied3323
Prior to Re-treatment, Cycle 1, Satisfied77
End of Re-treatment, Cycle 1, Satisfied147
Prior to Re-treatment, Cycle 2, Satisfied52
End of Re-treatment, Cycle 2, Satisfied71
SecondaryPatient Psoriasis Satisfaction Questionnaire (PSSQ): Your Comfort Level With Your Personal Appearance, at Baseline, Before Retreatment, and at the End of Retreatment

Participants completed a satisfaction survey at baseline and throughout the study. Participants were asked to rate, based on their experience during the past week, how satisfied or dissatisfied they were with their psoriasis therapy in general. Responses were based on a 5-point scale: Very dissatisfied (0) to very satisfied (4), and never had this problem (5).

Time frame:
Baseline to Week 52
Reported as:
Number · Number of Participants
Patient Psoriasis Satisfaction Questionnaire (PSSQ): Your Comfort Level With Your Personal Appearance, at Baseline, Before Retreatment, and at the End of Retreatment
Number of ParticipantsStop ArmMaintenance Arm
Baseline, Subjects Satisfied6458
Prior to Re-treatment, Cycle 1, Satisfied176
End of Re-treatment, Cycle 1, Satisfied358
Prior to Re-treatment, Cycle 2, Satisfied81
End of Re-treatment, Cycle 2, Satisfied102
SecondaryPatient Psoriasis Satisfaction Questionnaire (PSSQ): Anxiety, at Baseline, Before Retreatment, and at the End of Retreatment

Participants completed a satisfaction survey at baseline and throughout the study. Participants were asked to rate, based on their experience during the past week, how satisfied or dissatisfied they were with their psoriasis therapy in general. Responses were based on a 5-point scale: Very dissatisfied (0) to very satisfied (4), and never had this problem (5).

Time frame:
Baseline to Week 52
Reported as:
Number · Number of Participants
Patient Psoriasis Satisfaction Questionnaire (PSSQ): Anxiety, at Baseline, Before Retreatment, and at the End of Retreatment
Number of ParticipantsStop ArmMaintenance Arm
Baseline, Subjects Satisfied4336
Prior to Re-treatment, Cycle 1, Satisfied136
End of Re-treatment, Cycle 1, Satisfied175
Prior to Re-treatment, Cycle 2, Satisfied52
End of Re-treatment, Cycle 2, Satisfied51
SecondaryPatient Psoriasis Satisfaction Questionnaire (PSSQ): Depression, at Baseline, Before Retreatment, and at the End of Retreatment

Participants completed a satisfaction survey at baseline and throughout the study. Participants were asked to rate, based on their experience during the past week, how satisfied or dissatisfied they were with their psoriasis therapy in general. Responses were based on a 5-point scale: Very dissatisfied (0) to very satisfied (4), and never had this problem (5).

Time frame:
Baseline to Week 52
Reported as:
Number · Number of Participants
Patient Psoriasis Satisfaction Questionnaire (PSSQ): Depression, at Baseline, Before Retreatment, and at the End of Retreatment
Number of ParticipantsStop ArmMaintenance Arm
Baseline, Subjects Satisfied3931
Prior to Re-treatment, Cycle 1, Satisfied155
End of Re-treatment, Cycle 1, Satisfied173
Prior to Re-treatment, Cycle 2, Satisfied61
End of Re-treatment, Cycle 2, Satisfied61
SecondaryPatient Psoriasis Satisfaction Questionnaire (PSSQ): Fatigue, at Baseline, Before Retreatment, and at the End of Retreatment

Participants completed a satisfaction survey at baseline and throughout the study. Participants were asked to rate, based on their experience during the past week, how satisfied or dissatisfied they were with their psoriasis therapy in general. Responses were based on a 5-point scale: Very dissatisfied (0) to very satisfied (4), and never had this problem (5).

Time frame:
Baseline to Week 52
Reported as:
Number · Number of Participants
Patient Psoriasis Satisfaction Questionnaire (PSSQ): Fatigue, at Baseline, Before Retreatment, and at the End of Retreatment
Number of ParticipantsStop ArmMaintenance Arm
Baseline, Subjects Satisfied4443
Prior to Re-treatment, Cycle 1, Satisfied137
End of Re-treatment, Cycle 1, Satisfied206
Prior to Re-treatment, Cycle 2, Satisfied72
End of Re-treatment, Cycle 2, Satisfied92
SecondaryPatient Psoriasis Satisfaction Questionnaire (PSSQ): How Others Respond to Your Personal Appearance at Work/School, at Baseline, Before Retreatment, and at the End of Retreatment

Participants completed a satisfaction survey at baseline and throughout the study. Participants were asked to rate, based on their experience during the past week, how satisfied or dissatisfied they were with their psoriasis therapy in general. Responses were based on a 5-point scale: Very dissatisfied (0) to very satisfied (4), and never had this problem (5).

Time frame:
Baseline to Week 52
Reported as:
Number · Number of Participants
Patient Psoriasis Satisfaction Questionnaire (PSSQ): How Others Respond to Your Personal Appearance at Work/School, at Baseline, Before Retreatment, and at the End of Retreatment
Number of ParticipantsStop ArmMaintenance Arm
Baseline, Subjects Satisfied5048
Prior to Re-treatment, Cycle 1, Satisfied207
End of Re-treatment, Cycle 1, Satisfied289
Prior to Re-treatment, Cycle 2, Satisfied72
End of Re-treatment, Cycle 2, Satisfied81
SecondaryPatient Psoriasis Satisfaction Questionnaire (PSSQ): How Your Skin Affects Your Social and Leisure Activities, at Baseline, Before Retreatment, and at the End of Retreatment

Participants completed a satisfaction survey at baseline and throughout the study. Participants were asked to rate, based on their experience during the past week, how satisfied or dissatisfied they were with their psoriasis therapy in general. Responses were based on a 5-point scale: Very dissatisfied (0) to very satisfied (4), and never had this problem (5).

Time frame:
Baseline to Week 52
Reported as:
Number · Number of Participants
Patient Psoriasis Satisfaction Questionnaire (PSSQ): How Your Skin Affects Your Social and Leisure Activities, at Baseline, Before Retreatment, and at the End of Retreatment
Number of ParticipantsStop ArmMaintenance Arm
Baseline, Subjects Satisfied5645
Prior to Re-treatment, Cycle 1, Satisfied239
End of Re-treatment, Cycle 1, Satisfied298
Prior to Re-treatment, Cycle 2, Satisfied80
End of Re-treatment, Cycle 2, Satisfied90
SecondaryPatient Psoriasis Satisfaction Questionnaire (PSSQ): How Satisfied Were You With Your Psoriasis Treatment in General? at Baseline, Before Retreatment, and at the End of Retreatment

Participants completed a satisfaction survey at baseline and throughout the study. Participants were asked to rate, based on their experience during the past week, how satisfied or dissatisfied they were with their psoriasis therapy in general. Responses were based on a 5-point scale: Very dissatisfied (0) to very satisfied (4), and never had this problem (5).

Time frame:
Baseline to Week 52
Reported as:
Number · Number of Participants
Patient Psoriasis Satisfaction Questionnaire (PSSQ): How Satisfied Were You With Your Psoriasis Treatment in General? at Baseline, Before Retreatment, and at the End of Retreatment
Number of ParticipantsStop ArmMaintenance Arm
Baseline, Subjects Satisfied8479
Prior to Re-treatment, Cycle 1, Satisfied3013
End of Re-treatment, Cycle 1, Satisfied3917
Prior to Re-treatment, Cycle 2, Satisfied74
End of Re-treatment, Cycle 2, Satisfied104
SecondaryPatient Psoriasis Satisfaction Questionnaire (PSSQ): I Would Like to Continue With my Current Psoriasis Treatment, at Baseline, Before Retreatment, and at the End of Retreatment

Participants completed a satisfaction survey at baseline and throughout the study. Participants were asked to rate, based on their experience during the past week, how satisfied or dissatisfied they were with their psoriasis therapy in general. Responses were based on a 5-point scale: Very dissatisfied (0) to very satisfied (4), and never had this problem (5).

Time frame:
Baseline to Week 52
Reported as:
Number · Number of Participants
Patient Psoriasis Satisfaction Questionnaire (PSSQ): I Would Like to Continue With my Current Psoriasis Treatment, at Baseline, Before Retreatment, and at the End of Retreatment
Number of ParticipantsStop ArmMaintenance Arm
Baseline, Subjects Satisfied8278
Prior to Re-treatment, Cycle 1, Satisfied3416
End of Re-treatment, Cycle 1, Satisfied4118
Prior to Re-treatment, Cycle 2, Satisfied114
End of Re-treatment, Cycle 2, Satisfied104
SecondaryPhysician Global Assessment (PGA) of Disease Activity at Week 52

Participants completed a satisfaction survey at baseline and throughout the study. Participants were asked to rate, based on their experience during the past week, how satisfied or dissatisfied they were with their psoriasis therapy in general. Responses were based on a 5-point scale: Very dissatisfied (0) to very satisfied (4), and never had this problem (5).

Time frame:
Week 52
Reported as:
Mean · Units on a scale
Physician Global Assessment (PGA) of Disease Activity at Week 52
Units on a scaleStop ArmMaintenance Arm
Physician Global Assessment (PGA) of Disease Activity at Week 521.8 ± 1.021.4 ± 1.00

Adverse events

Collected over Post baseline period. Non-serious events are listed at a 5% frequency threshold.

Adverse event summary by group
GroupDeathsSeriousOther
Stop Arm—6/87 (6.9%)25/87 (28.7%)
Maintenance Arm—4/84 (4.8%)32/84 (38.1%)
Most frequent serious events
Showing 10 of 14
Most frequent serious events
EventStop ArmMaintenance Arm
Angina PectorisCardiac disorders0/871/84
PyrexiaGeneral disorders0/871/84
Bacterial PyelonephritisInfections and infestations0/871/84
Escherichia Urinary Tract InfectionInfections and infestations0/871/84
FuruncleInfections and infestations0/871/84
SinusitisInfections and infestations0/871/84
Facial Bones FractureInjury, poisoning and procedural complications0/871/84
Inguinal HerniaGastrointestinal disorders1/870/84
Animal BiteInjury, poisoning and procedural complications1/870/84
Viith Nerve ParalysisGastrointestinal disorders1/870/84
Most frequent other events
Most frequent other events
EventStop ArmMaintenance Arm
NasopharyngitisInfections and infestations10/8722/84
BronchitisInfections and infestations5/879/84
ArthralgiaMusculoskeletal and connective tissue disorders8/876/84
PharyngitisInfections and infestations5/873/84

Baseline characteristics

A total of 174 subjects were randomized.Three subjects were randomized but did not take at least 1 dose of investigational product, and were therefore excluded from the safety population. One subject was excluded from the mITT population. The reason for exclusion was lack of at least one post-baseline PGA.

Age, Continuous
Age, Continuous(Years)Stop ArmMaintenance ArmTotal
Mean50.39 ± 14.1047.71 ± 13.7749.08 ± 13.96
Sex: Female, Male
Sex: Female, Male(Participants)Stop ArmMaintenance ArmTotal
Female293160
Male5853111
08

Study locations

46 sites
  • Centre Hopitalier St Jacques (Place St Jacques)
    Besancon, 25030, France
  • CHU Dupuytren
    Limoges, 87042, France
  • Service de Chirurgie Infantile
    Lyon Cedex 03, 69437, France
  • C.H.U Nantes
    Nantes Cedex 01, 44093, France
  • CHU de l Archet
    Nice Cedex 03, 06202, France
  • Hopital Saint Louis
    Paris, 75010, France
  • Centre Hospitalier Lyon Sud
    Pierre Benite, 69495, France
  • CHU de Poitiers
    Poitiers, 86000, France
  • C.H.U de Reims
    Reims, 51100, France
  • Hôpital Purpan
    Toulouse Cedex, 31059, France
  • Klinik fuer Dermatologie, Allergologie und Venerologie
    Berlin, 10117, Germany
  • St. Josef-Klinikum
    Bochum, 44791, Germany
  • Universitaetsklinikum Erlangen Hautklinik im Internistischen Zentrum
    Erlangen, 91054, Germany
  • J. W. Goethe Universitaet Frankfurt, Zentrum fuer Dermatologie und Venerologie
    Frankfurt am Main, 60590, Germany
  • Klinikum der Albert-Ludwigs-Universitaet
    Freiburg, 79104, Germany
  • Universitätsklinikum-Eppendorf Martinistr. 20, Hamburg 20158
    Hamburg, 20246, Germany
  • Dermatologische Gemeinschaftspraxis Rosenbach
    Osnabrueck, 49078, Germany
  • "Andreas Sygros" Hospital
    Athens, 16121, Greece
  • Papageorgiou General Peripheral Hospital of Thessaloniki
    Thessaloniki, 56429, Greece
  • Semmelweis Egyetem, Bor-, Nemikortani es Boronkologiai Klinika
    Budapest, 1085, Hungary
  • Debreceni Egyetem Orvos-és Egészségtudományi Centrum
    Debrecen, 4012, Hungary
  • Miskolci Egeszsegugyi Kozpont
    Miskolc, 3529, Hungary
  • SZTE, Szent-Gyorgyi Albert Klinikai Kozpont, Borgyogyaszati es Allergologiai Klinika
    Szeged, 6720, Hungary
  • Clinica Dermatologica - Universita' di Catania
    Catania, 95123, Italy
  • Centro di Ricerca Clinica Fondazione Universita' degli Studi Gabriele D'Annunzio
    Chieti, 66013, Italy
  • U.O. Dermatologia
    Parma, 43100, Italy
  • Hospital Universitario Marques de Valdecilla
    Santander, Cantabria 39008, Spain
  • Fundacion Hospital Alcorcon
    Alcorcon, Madrid 28922, Spain
  • Hospital Universitario de Getafe
    Getafe, Madrid 28905, Spain
  • Hospital General Universitario Alicante C/ Maestro Alonso, 1
    Alicante, 3010, Spain
  • Hospital La Paz
    Madrid, 28046, Spain
  • Virgen de la VICTORIA
    Malaga, 29010, Spain
  • Istanbul Universitesi
    Istanbul, Capa 34390, Turkey
  • Gulhane Askeri Tip Akademisi Tip Fakultesi
    Ankara, Etlik 06010, Turkey
  • Gulhane Askeri Tip Fakultesi
    Ankara, Etlik 06018, Turkey
  • Gulhane Military Medical Academy, Faculty of Medicine
    Ankara, Etlik 06018, Turkey
  • Bezm-i Alem Vakif Universitesi Tip Fakultesi Hastanesi
    Istanbul, Fatih 34093, Turkey
  • Uludag Universitesi
    Bursa, Gorukle 16059, Turkey
  • T.C. Saglik Bakanligi Marmara Universitesi Egitim ve Arastirma Hastanesi Dermatoloji Anabilim Dali
    Pendik, Istanbul 34890, Turkey
  • Gazi Universitesi
    Ankara, Sihhiye 06100, Turkey
  • Hacettepe Universitesi
    Ankara, Sihhiye 06100, Turkey
  • Hacettepe Universitesi
    Ankara, Turkey
  • Ege Universitesi Tip Fakultesi Dermatoloji Anabilim Dali
    Bornova / Izmir, 35100, Turkey
  • Sheikh Khalifa Medical City
    Abu Dhabi, UAE 51900, United Arab Emirates
  • Harrogate District Hospital
    Harrogate, HG2 7SX, United Kingdom
  • Whipps Cross Hospital
    London, E11 1NR, United Kingdom
09

References and documents

10

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jan 8, 2016, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
11

Registry details

Key details

Study ID
NCT00992394
Lead sponsor
Pfizer
Responsible party
Sponsor
First posted
Oct 9, 2009
Start date
Jan 2010
Primary completion
Apr 2013
Completion
Apr 2013
Results posted
Jan 8, 2016
Last update
Jan 8, 2016

Study contacts

Pfizer CT.gov Call Center
study director · Pfizer

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

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