PsoriasisPhase 4NCT00735787
Controlled Study of Humira in Subjects With Chronic Plaque Psoriasis of the Hands and/or Feet
A Phase 4 study testing Adalimumab in people with Psoriasis, run by Abbott at 17 sites in 2 countries.
Trial summary
Evaluate the efficacy and safety of a 16-week course of Humira (adalimumab) compared to placebo in adults with chronic plaque psoriasis of the hands and/or feet and the sustainability of response for 12 additional weeks. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Psoriasis
- What is being tested?
- Adalimumab
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 81 participants
- Where
- 17 sitesin 2 countries
- Study dates
- Aug 2008to Sep 2009
- Phase
- Phase 4
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Adult with Diagnosis of chronic plaque psoriasis of the Hands and Feet for at least 6 months, with a PGA >/=3 and candidates for systemic therapy;
- Patients in good general health
- Able to self-administer injections
- Negative chest x-ray (CXR) and purified protein derivative (PPD) test, unless willing to start anti-tuberculosis (TB) prophylaxis
Who cannot join
- Previous treatment with HUMIRA®
- Required mediation stability or washouts for: systemic corticosteroids (28 days), other investigational agent, other systemic therapies for psoriasis, ultraviolet B (UVB), psoralen with UVA (PUVA)
- Other active skin diseases or skin infections
- Diagnosis of palmoplantar pustulosis; erythrodermic psoriasis, pustular psoriasis, medication-induced or exacerbated psoriasis or new onset of guttate psoriasis
- Evidence of dysplasia or history of malignancy (Other than a successfully treated non-metastatic cutaneous squamous cell, basal cell carcinoma or localized carcinoma in situ of the cervix);
- History of listeriosis, histoplasmosis, chronic or active Hepatitis B infection, human immunodeficiency virus (HIV) infection, immunodeficiency syndrome, chronic recurring infections or active tuberculosis (TB);
Show all 14Show fewer
- History of moderate to severe congestive heart failure,
- Recent cerebrovascular accident and any other condition which, in the opinion of the investigator, would put the subject at risk;
- History of central nervous system (CNS) demyelinating disease or neurologic symptoms suggestive of CNS demyelinating disease;
- History of clinically significant drug or alcohol abuse in the last 12 months;
- Infection(s) requiring treatment with intravenous (IV) antibiotics, IV antivirals, or IV antifungals within 30 days prior to Baseline or oral antibiotics, oral antivirals, or oral antifungals within 14 days prior to Baseline;
- Known hypersensitivity to the excipients of HUMIRA® as stated in the label;
- Female subjects who are pregnant or breast-feeding or considering becoming pregnant during the study.
- Prior exposure to Tysabri® (natalizumab)
Trial locations and contacts
17 sites in 2 countries.
17 sites in 2 countries
Canada9 sites
Site Reference ID/Investigator# 10180
Edmonton, Alberta, T5K 1X3
Site Reference ID/Investigator# 10170
Halifax, Nova Scotia, B3H 1Z4
Site Reference ID/Investigator# 10179
Hamilton, Ontario, L8N 1V6
Site Reference ID/Investigator# 10004
London, Ontario, N5X 2P1
Site Reference ID/Investigator# 10165
Montreal, Quebec, H2K 4L5
Site Reference ID/Investigator# 10177
North Bay, Ontario, P1B 3Z7
Site Reference ID/Investigator# 10176
Québec, Quebec, G1V 4X7
Site Reference ID/Investigator# 10169
Vancouver, British Columbia, V5Z 4E8
Site Reference ID/Investigator# 10175
Waterloo, Ontario, N2J 1C4
United States8 sites
Site Reference ID/Investigator# 10005
Bakersfield, California, 93309
Site Reference ID/Investigator# 10173
Dallas, Texas, 75246-1613
Site Reference ID/Investigator# 10164
East Windsor, New Jersey, 08520
Site Reference ID/Investigator# 11302
Houston, Texas, 77030
Site Reference ID/Investigator# 10168
Little Rock, Arkansas, 72205
Site Reference ID/Investigator# 10003
Macon, Georgia, 31217
Site Reference ID/Investigator# 10166
San Antonio, Texas, 78258
Site Reference ID/Investigator# 10171
St Louis, Missouri, 63117
About this study
Evaluate the efficacy and safety of a 16-week course of Humira (adalimumab) compared to placebo in adults with chronic plaque psoriasis of the hands and/or feet and the sustainability of response for 12 additional weeks.
- Conditions
- Psoriasis
- Being tested
- Placebo, Adalimumab
- Medical subject headings
- Psoriasis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PlaceboBiological
Loading dose of 2 placebo subcutaneous (SC) injections (0.8 ml) at Week 0 followed by 1 injection SC eow from Week 1 to Week 15.In second period of study, subjects who continued in the study received 80 mg adalimumab at Week 16 followed by open-label 40 mg adalimumab eow from Week 17 to Week 27.
AdalimumabBiological
Also called Humira, ABT-D2E7
Loading dose of 80 mg adalimumab SC (two 40 mg injections) followed by 40 mg adalimumab SC eow.
| Study group | Role | What they receive |
|---|---|---|
| Placebo/Adalimumab | Placebo comparator | Loading dose of 2 placebo injections at Week 0 and placebo injections every other week (eow) from Week 1 through Week 15.
In second period of study, subjects who continued in the study received 80 mg adalimumab at Week 16 followed by open-label 40 mg adalimumab eow from Week 17 to Week 27. Receives: Biological: Placebo; Biological: Adalimumab |
| Adalimumab | Active comparator | 80 mg adalimumab loading dose at Week 0 and 40 mg adalimumab eow from Weeks 1 through 15. For subjects who continued in the second period of the study, subjects received 2 placebo injections at Week 16 to maintain the blind. Open-label 40 mg adalimumab eow was administered from Week 17 through Week 27. Receives: Biological: Adalimumab |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Subjects With Physician's Global Assessment of Psoriasis (PGA) of Clear or Almost Clear at Week 16
Number of subjects achieving a PGA of clear (representing no signs of plaque psoriasis) or almost clear (representing just perceptible erythema and scaling) at Week 16. The PGA is a 5-point scale used to measure the severity of disease at the time of the physician's evaluation of the subject. The degree of overall severity is rated as follows: 0-Clear, 1-Almost clear, 2-Mild, 3-Moderate, and 4-Severe.
Measured: Week 16
Secondary outcomes (19)
Mean Change From Baseline in Erythema, Scaling, Induration, and Fissuring (ESIF)
Severity of each sign of ESIF was assessed using a 4-point scale (0 = clear, 1 = mild, 2 = moderate, and 3 = severe). The ESIF was calculated by adding the scores for the 4 signs for the two soles and two palms, for a total range from 0 (no disease) to 48 points (most severe condition). A decrease from Baseline in ESIF indicates improvement.
Measured: Baseline and Weeks 2, 4, 8, 12, 16, 20, 24, 28
Mean Change From Baseline in ESIF for Palms
Severity of each sign of ESIF was assessed using a 4-point scale (0 = clear, 1 = mild, 2 = moderate, and 3 = severe). The ESIF was calculated by adding the scores for the 4 signs for the palms of the hands, yielding a total range from 0 (no disease) to 24 points (most severe condition) for the palms. A decrease from Baseline in ESIF indicates improvement.
Measured: Baseline and Weeks 2, 4, 12, 16, 20, 24, and 28
Mean Change From Baseline in ESIF for Soles
Severity of each sign of ESIF was assessed using a 4-point scale (0 = clear, 1 = mild, 2 = moderate, and 3 = severe). The ESIF was calculated by adding the scores for the 4 signs for the soles of the feet, yielding a total range from 0 (no disease) to 24 points (most severe condition) for the soles. A decrease from Baseline in ESIF indicates improvement.
Measured: Baseline and Weeks 2, 4, 8, 12, 16, 20, 24, 28
Number of Subjects With Moderate Improvement in ESIF From Baseline
Number of subjects that achieved > 50% reduction from Baseline in ESIF.
Measured: Baseline and Weeks 2, 4, 8, 12, 16, 20, 24, 28
Number of Subjects With Marked Improvement in ESIF From Baseline
Number of subjects that achieved > 75% reduction from Baseline in ESIF
Measured: Baseline and Weeks 2, 4, 8, 12, 16, 20, 24, 28
Mean Change From Baseline in Nail Psoriasis Severity Index (NAPSI)
For subjects with psoriasis nail involvement at Baseline, the target fingernail (most severely involved fingernail at Baseline) was assessed for NAPSI throughout the study. NAPSI ranges from 0 (no nail psoriasis) to 8 (most severe nail psoriasis).
Measured: Baseline and Weeks 8, 16, and 28
Number of Subjects With Physicians Global Assessment of Psoriasis (PGA) of Clear, Almost Clear, or Mild
Number of subjects achieving a PGA of clear (representing no signs of plaque psoriasis), almost clear (representing just perceptible erythema and scaling), or mild (representing light pink erythema with minimal scaling and with or without pustules). The PGA is a 5-point scale used to measure the severity of disease at the time of the physician's evaluation of the subject. The degree of overall severity is rated as follows: 0-Clear, 1-Almost clear, 2-Mild, 3-Moderate, and 4-Severe.
Measured: Baseline and Weeks 2, 4, 8, 12, 16, 20, 24, and 28
Number of Subjects With PGA of Clear or Almost Clear
Number of subjects achieving a PGA of clear (representing no signs of plaque psoriasis) or almost clear (representing just perceptible erythema and scaling). The PGA is a 5-point scale used to measure the severity of disease at the time of the physician's evaluation of the subject. The degree of overall severity is rated as follows: 0-Clear, 1-Almost clear, 2-Mild, 3-Moderate, and 4-Severe.
Measured: Baseline and Weeks 2, 4, 8, 12, 20, 24, and 28
Number of Subjects With PGA of Clear
Number of subjects achieving a PGA of clear (representing no signs of plaque psoriasis). The PGA is a 5-point scale used to measure the severity of disease at the time of the physician's evaluation of the subject. The degree of overall severity is rated as follows: 0-Clear, 1-Almost clear, 2-Mild, 3-Moderate, and 4-Severe.
Measured: Baseline and Weeks 2, 4, 8, 12, 16, 20, 24, and 28
Number of Subjects With Psoriasis Area and Severity Index (PASI) 50
Number of subjects who achieved 50% or greater improvement from baseline PASI. The PASI scale is from 0 (no psoriasis) to 72 (complete erythroderma of the severest possible degree).
Measured: Baseline and Weeks 16 and 28
Number of Subjects With PASI 75
Number of subjects who achieved 75% or greater improvement from baseline PASI. The PASI scale is from 0 (no psoriasis) to 72 (complete erythroderma of the severest possible degree).
Measured: Baseline and Weeks 16 and 28
Number of Subjects With PASI 90
Number of subjects who achieved 90% or greater improvement from baseline PASI. The PASI scale is from 0 (no psoriasis) to 72 (complete erythroderma of the severest possible degree).
Measured: Baseline and Weeks 16 and 28
Number of Subjects With PASI 100
Number of subjects who achieved 100% improvement from baseline PASI. The PASI scale is from 0 (no psoriasis) to 72 (complete erythroderma of the severest possible degree).
Measured: Baseline and Weeks 16 and 28
Mean Change From Baseline in Dermatology Life Quality Index (DLQI)
The DLQI consists of 10 questions and is scored from 0 (total lack of impairment) to 30 (life is very much impaired). A decrease in DLQI indicates improvement.
Measured: Baseline and Weeks 2, 8, 16, and 28
Number of Subjects Achieving a DLQI of 0
Number of subjects achieving a DLQI score of 0, indicating total lack of impairment. The DLQI consists of 10 questions and is scored from 0 to 30 (life is very much impaired). A decrease in DLQI indicates improvement.
Measured: Baseline and Weeks 2, 8, 16, and 28
Mean Change From Baseline in Visual Analog Scale (VAS) for Psoriasis and Psoriatic Arthritis Pain
On one single VAS, subjects assessed their pain due to psoriasis (and psoriatic arthritis, if applicable). Mean change in psoriasis and psoriatic arthritis pain from Baseline as measured by a VAS from 0 (no pain) to 100 (pain as bad as it could be).
Measured: Baseline and Weeks 16 and 28
Mean Change From Baseline in Work Productivity and Activity Impairment Questionnaire: Psoriasis (WPAI:PSO)
WPAI:PSO assesses the effect on the subject's ability to work and perform regular activities in 4 areas: % work time (in hours) missed due to psoriasis, % impairment while working (on a scale from 0 [psoriasis having no effect] to 10 [psoriasis completely prevented subject from working]), % overall work impairment (on a scale from 0 [psoriasis having no effect] to 10 [psoriasis completely prevented subject from working]), and % activity impairment (on a scale from 0 [psoriasis having no effect on daily activities] to 10 [psoriasis completely prevented subject from doing daily activities]).
Measured: Baseline and Weeks 8, 16, and 28
Mean Change From Baseline in Patient Health Questionnaire (PHQ-9)
The PHQ-9 consists of 9 questions that assess how often over the past 2 weeks subjects had signs or symptoms of depression (0=not at all, 1=several days, 2=more than half days, and 3=nearly every day). The PHQ-9 is the sum of the scores from the 9 questions for a total range from 0 (not depressed at all) to 27 (depressed nearly every day).
Measured: Baseline and Weeks 2, 8, 16, and 28
Number of Subjects With Difficulties According to PHQ-9
Based on the 9 questions of the PHQ-9, if subjects indicated any problems (PHQ-9 score > 0), the difficulty to do work, take care of things at home, and get along with people (question 10 of the PHQ) were assessed (not difficult at all, somewhat difficult, very difficult, and extremely difficult).
Measured: Baseline and Weeks 2, 8, 16, and 28
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Aug 2008 (estimated)
- Study startAug 2008
- Primary completionSep 2009
- Study completionSep 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for PsoriasisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 81 participants (actual)
Sponsor and investigators
- Lead sponsor
- Abbott
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Martin Okun, MD, Study director, Abbott
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00735787
- Sponsor's protocol ID
- M10-405
- Status last verified
- Oct 2010
- First submitted
- 13 Aug 2008
- Last updated
- 1 Nov 2010
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Publications
Leonardi C, Langley RG, Papp K, Tyring SK, Wasel N, Vender R, Unnebrink K, Gupta SR, Valdecantos WC, Bagel J. Adalimumab for treatment of moderate to severe chronic plaque psoriasis of the hands and feet: efficacy and safety results from REACH, a randomized, placebo-controlled, double-blind trial. Arch Dermatol. 2011 Apr;147(4):429-36. doi: 10.1001/archdermatol.2010.384. Epub 2010 Dec 20.
PubMed 21173304
Study at a glance
From the registry record, last updated by the sponsor on 1 Nov 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Controlled Study of Humira in Subjects With Chronic Plaque Psoriasis of the Hands and/or Feet
- ClinicalTrials.gov ID
- NCT00735787
- Acronym / sponsor ID
- M10-405
- Conditions
- Psoriasis
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 81 participants (actual)
- Lead sponsor
- AbbottIndustry (pharma, biotech, devices)
- Study start
- Aug 2008
- Primary completion
- Sep 2009 (actual)
- Study completion
- Sep 2009 (actual)
- First posted
- 15 Aug 2008 (estimated)
- Results
- Posted 1 Nov 2010
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Evaluate the efficacy and safety of a 16-week course of Humira (adalimumab) compared to placebo in adults with chronic plaque psoriasis of the hands and/or feet and the sustainability of response for 12 additional weeks.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Placebo/Adalimumab | Placebo comparator | Biological: Placebo, Biological: AdalimumabLoading dose of 2 placebo injections at Week 0 and placebo injections every other week (eow) from Week 1 through Week 15. In second period of study, subjects who continued in the study received 80 mg adalimumab at Week 16 followed by open-label 40 mg adalimumab eow from Week 17 to Week 27. |
| Adalimumab | Active comparator | Biological: Adalimumab80 mg adalimumab loading dose at Week 0 and 40 mg adalimumab eow from Weeks 1 through 15. For subjects who continued in the second period of the study, subjects received 2 placebo injections at Week 16 to maintain the blind. Open-label 40 mg adalimumab eow was administered from Week 17 through Week 27. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Adult with Diagnosis of chronic plaque psoriasis of the Hands and Feet for at least 6 months, with a PGA >/=3 and candidates for systemic therapy;
- Patients in good general health
- Able to self-administer injections
- Negative chest x-ray (CXR) and purified protein derivative (PPD) test, unless willing to start anti-tuberculosis (TB) prophylaxis
Key exclusion criteria (14 listed)
- Previous treatment with HUMIRA®
- Required mediation stability or washouts for: systemic corticosteroids (28 days), other investigational agent, other systemic therapies for psoriasis, ultraviolet B (UVB), psoralen with UVA (PUVA)
- Other active skin diseases or skin infections
- Diagnosis of palmoplantar pustulosis; erythrodermic psoriasis, pustular psoriasis, medication-induced or exacerbated psoriasis or new onset of guttate psoriasis
- Evidence of dysplasia or history of malignancy (Other than a successfully treated non-metastatic cutaneous squamous cell, basal cell carcinoma or localized carcinoma in situ of the cervix);
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| PlaceboLoading dose of 2 placebo subcutaneous (SC) injections (0.8 ml) at Week 0 followed by 1 injection SC eow from Week 1 to Week 15.In second period of study, subjects who continued in the study received 80 mg adalimumab at Week 16 followed by open-label 40 mg adalimumab eow from Week 17 to Week 27. | Biological | Placebo/Adalimumab |
| AdalimumabAlso: Humira, ABT-D2E7Loading dose of 80 mg adalimumab SC (two 40 mg injections) followed by 40 mg adalimumab SC eow. | Biological | Adalimumab, Placebo/Adalimumab |
Primary outcome
Number of Subjects With Physician's Global Assessment of Psoriasis (PGA) of Clear or Almost Clear at Week 16
Time frame: Week 16
Number of subjects achieving a PGA of clear (representing no signs of plaque psoriasis) or almost clear (representing just perceptible erythema and scaling) at Week 16. The PGA is a 5-point scale used to measure the severity of disease at the time of the physician's evaluation of the subject. The degree of overall severity is rated as follows: 0-Clear, 1-Almost clear, 2-Mild, 3-Moderate, and 4-Severe.
19 secondary outcomes
Mean Change From Baseline in Erythema, Scaling, Induration, and Fissuring (ESIF)
Time frame: Baseline and Weeks 2, 4, 8, 12, 16, 20, 24, 28
Mean Change From Baseline in ESIF for Palms
Time frame: Baseline and Weeks 2, 4, 12, 16, 20, 24, and 28
Mean Change From Baseline in ESIF for Soles
Time frame: Baseline and Weeks 2, 4, 8, 12, 16, 20, 24, 28
Number of Subjects With Moderate Improvement in ESIF From Baseline
Time frame: Baseline and Weeks 2, 4, 8, 12, 16, 20, 24, 28
Number of Subjects With Marked Improvement in ESIF From Baseline
Time frame: Baseline and Weeks 2, 4, 8, 12, 16, 20, 24, 28
Mean Change From Baseline in Nail Psoriasis Severity Index (NAPSI)
Time frame: Baseline and Weeks 8, 16, and 28
Number of Subjects With Physicians Global Assessment of Psoriasis (PGA) of Clear, Almost Clear, or Mild
Time frame: Baseline and Weeks 2, 4, 8, 12, 16, 20, 24, and 28
Number of Subjects With PGA of Clear or Almost Clear
Time frame: Baseline and Weeks 2, 4, 8, 12, 20, 24, and 28
Number of Subjects With PGA of Clear
Time frame: Baseline and Weeks 2, 4, 8, 12, 16, 20, 24, and 28
Number of Subjects With Psoriasis Area and Severity Index (PASI) 50
Time frame: Baseline and Weeks 16 and 28
Number of Subjects With PASI 75
Time frame: Baseline and Weeks 16 and 28
Number of Subjects With PASI 90
Time frame: Baseline and Weeks 16 and 28
Number of Subjects With PASI 100
Time frame: Baseline and Weeks 16 and 28
Mean Change From Baseline in Dermatology Life Quality Index (DLQI)
Time frame: Baseline and Weeks 2, 8, 16, and 28
Number of Subjects Achieving a DLQI of 0
Time frame: Baseline and Weeks 2, 8, 16, and 28
Mean Change From Baseline in Visual Analog Scale (VAS) for Psoriasis and Psoriatic Arthritis Pain
Time frame: Baseline and Weeks 16 and 28
Mean Change From Baseline in Work Productivity and Activity Impairment Questionnaire: Psoriasis (WPAI:PSO)
Time frame: Baseline and Weeks 8, 16, and 28
Mean Change From Baseline in Patient Health Questionnaire (PHQ-9)
Time frame: Baseline and Weeks 2, 8, 16, and 28
Number of Subjects With Difficulties According to PHQ-9
Time frame: Baseline and Weeks 2, 8, 16, and 28
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Nov 2010.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 21173304Leonardi C, Langley RG, Papp K, Tyring SK, Wasel N, Vender R, Unnebrink K, Gupta SR, Valdecantos WC, Bagel J. Adalimumab for treatment of moderate to severe chronic plaque psoriasis of the hands and feet: efficacy and safety results from REACH, a randomized, placebo-controlled, double-blind trial. Arch Dermatol. 2011 Apr;147(4):429-36. doi: 10.1001/archdermatol.2010.384. Epub 2010 Dec 20.
- prescribing informationLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Martin Okun, MD study director
Abbott
17 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Adalimumab in people with Psoriasis, run by Abbott at 17 sites in 2 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 1 Nov 2010. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 17 sites in Canada, United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 1 Nov 2010). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of Subjects With Physician's Global Assessment of Psoriasis (PGA) of Clear or Almost Clear at Week 16 (time frame: Week 16). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00735787, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Nov 2010; AzTrials last refreshed its copy on 7 Nov 2026.