Moderate to Severe Plaque PsoriasisPhase 4NCT01644396
An Open-Label, Prospective Study to Assess the Safety and Effectiveness of Adalimumab in Patients With Moderate to Severe Plaque Psoriasis in the Russian Federation
A Phase 4 study testing Adalimumab in people with Moderate to Severe Plaque Psoriasis, run by AbbVie (prior sponsor, Abbott) at 7 sites in Russia.
Trial summary
This is an open-label study designed to establish the safety and effectiveness of adalimumab in the treatment of moderate to severe plaque psoriasis after 24 weeks of treatment. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Moderate to Severe Plaque Psoriasis
- What is being tested?
- Adalimumab
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 7 sitesRussia
- Study dates
- May 2012to Sep 2013
- 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
- A patient will be eligible for study participation if he/she meets the following criteria:
- Male and female patients ≥ 18 years of age.
- Clinical diagnosis of psoriasis for at least 6 months as determined by patient interview of his/her medical history and confirmation of diagnosis through physical examination by the investigator.
- Stable plaque psoriasis for at least 2 months before Screening and Baseline visits as determined by patient interview of his/her medical history.
- Moderate to severe plaque psoriasis defined by ≥ 10% Body Surface Area (BSA) involvement at the Baseline visit.
- PASI (Psoriasis Area and Severity Index) score ≥ 10 at the Baseline visit.
Who cannot join
- Diagnosis of erythrodermic psoriasis, pustular psoriasis, medication induced or medication-exacerbated psoriasis or new onset of guttate psoriasis.
- Diagnosis of other active skin diseases or skin infections (bacterial, fungal, or viral) that may interfere with evaluation of psoriasis.
- Patient who cannot discontinue topical therapies for the treatment of psoriasis such as corticosteroids, vitamin D analogs, or retinoids at least 14 days prior to the Baseline (Week 0) visit and during the study. Participants are allowed to use:
- Shampoos that contain no corticosteroid;
- Bland (without beta or alpha hydroxy acids or containing no psoriasis treatment) emollients;
- Low potency topical corticosteroids on the palms, soles, face, inframammary area, and groin only.
- Patient who cannot avoid UVB (Ultraviolet-B) phototherapy for at least 14 days prior to the Baseline (Week 0) visit and during the study.
- Patient who cannot avoid PUVA (psoralen + ultraviolet A) phototherapy for at least 28 days prior to the Baseline (Week 0) visit and during the study.
Trial locations and contacts
7 sites in 1 country.
7 sites in 1 country
Russia7 sites
Site Reference ID/Investigator# 78433
Kazan', 420012
Site Reference ID/Investigator# 67542
Moscow, 107076
Site Reference ID/Investigator# 78413
Saint Petersburg, 190013
Site Reference ID/Investigator# 67545
Saint Petersburg, 194044
Site Reference ID/Investigator# 67546
Saratov, 410028
Site Reference ID/Investigator# 78417
Smolensk, 214018
Site Reference ID/Investigator# 67547
Yekaterinburg, 620076
About this study
Official title: An Open-Label, Prospective Study to Assess the Safety and Effectiveness of Adalimumab (Humira®) in Patients With Moderate to Severe Plaque Psoriasis in the Russian Federation
This is an open-label study designed to establish the safety and effectiveness of adalimumab in the treatment of moderate to severe plaque psoriasis after 24 weeks of treatment.
Read the detailed description
During the treatment period, participants will receive an initial adalimumab 80 milligram (mg) subcutaneous (sc) dose, followed by adalimumab 40 mg sc every other week starting one week after initial dose. Safety and effectiveness assessments will be completed at Baseline, Week 2, Week 4, Week 8, Week 12, Week 16 and Week 24. Participants may discontinue adalimumab treatment at any time during study participation. Participants that end study participation early will have a Premature Discontinuation visit. All participants who do not initiate commercial Humira® will have a follow-up phone call 70 days after the last administration of study drug to obtain information on any new or ongoing Adverse Events (AEs). The 70-day follow-up phone call will not be required for any participant that initiates adalimumab therapy not supplied in the context of the clinical trial after the end of study participation.
- Conditions
- Moderate to Severe Plaque Psoriasis
- Being tested
- Adalimumab
- Keywords
- Moderate to Severe Plaque Psoriasis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AdalimumabBiological
Also called ABT-D2E7, Humira
| Study group | Role | What they receive |
|---|---|---|
| Adalimumab | Other | Participants received an initial adalimumab 80 mg subcutaneous dose, followed by adalimumab 40 mg subcutaneous every other week starting one week after the initial dose for up to 24 weeks. Receives: Biological: Adalimumab |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of Participants Achieving a Psoriasis Area and Severity Index 75 (PASI 75) Response at Week 24
The percentage of participants with a ≥ 75% reduction (improvement) in Psoriasis Area and Severity Index (PASI) score from Baseline. PASI is a combination of the intensity of psoriasis, assessed by the erythema (reddening), induration (plaque thickness) and desquamation (scaling) on a scale from no symptoms (0), slight (1), moderate (2), marked (3) or very marked (4), together with the percentage of the area affected, rated on a scale from 0 to 6. PASI scoring is performed at four body areas, the head, arms, trunk, and legs. The total PASI score ranges from 0 to 72. The higher the total score, the more severe the disease.
Measured: Baseline and Week 24
Secondary outcomes (10)
Percentage of Participants Achieving a Physician's Global Assessment of Clear
The Physician's Global Assessment (PGA) is a 6-point scale used to measure the severity of disease at the time of the qualified investigator's evaluation of the participant. The degree of overall lesion severity was evaluated using the following categories:
- 0: No evidence of scaling, erythema, or plaque elevation, overall score of cleared;
- 1: Occasional fine scale over <5% of lesions, faint erythema, minimal plaque elevation, overall score of minimal;
- 2: Fine scale dominates, light red coloration, mild plaque elevation, overall score of mild;
- 3: Course scale dominates, moderate red coloration, moderate plaque elevation, overall score of moderate;
- 4: Thick non-tenacious scale dominates, bright red coloration, marked plaque elevation, overall score of marked;
- 5: Very thick tenacious scale predominates, dusky to deep red coloration, severe plaque elevation, overall score of severe.
The percentage of participants achieving a PGA score of clear (0) is reported.
Measured: Weeks 2, 4, 8, 12, 16 and 24
Percentage of Participants Achieving a Physician's Global Assessment of Clear or Minimal
The Physician's Global Assessment (PGA) is a 6-point scale used to measure the severity of disease at the time of the qualified investigator's evaluation of the participant. The degree of overall lesion severity was evaluated using the following categories:
- 0: No evidence of scaling, erythema, or plaque elevation, overall score of cleared;
- 1: Occasional fine scale over <5% of lesions, faint erythema, minimal plaque elevation, overall score of minimal;
- 2: Fine scale dominates, light red coloration, mild plaque elevation, overall score of mild;
- 3: Course scale dominates, moderate red coloration, moderate plaque elevation, overall score of moderate;
- 4: Thick non-tenacious scale dominates, bright red coloration, marked plaque elevation, overall score of marked;
- 5: Very thick tenacious scale predominates, dusky to deep red coloration, severe plaque elevation, overall score of severe.
The percentage of participants achieving a PGA score of clear (0) or minimal (1) is reported.
Measured: Weeks 2, 4, 8, 12, 16 and 24
Percentage of Participants Achieving a One Grade Improvement in Physician's Global Assessment (PGA)
The PGA is a 6-point scale used to measure the severity of disease at the time of the qualified investigator's evaluation of the participant. The degree of overall lesion severity was evaluated using the following categories:
- 0: No evidence of scaling, erythema, or plaque elevation, overall score of cleared;
- 1: Occasional fine scale over <5% of lesions, faint erythema, minimal plaque elevation, overall score of minimal;
- 2: Fine scale dominates, light red coloration, mild plaque elevation, overall score of mild;
- 3: Course scale dominates, moderate red coloration, moderate plaque elevation, overall score of moderate;
- 4: Thick non-tenacious scale dominates, bright red coloration, marked plaque elevation, overall score of marked;
- 5: Very thick tenacious scale predominates, dusky to deep red coloration, severe plaque elevation, overall score of severe.
The percentage of participants achieving a shift from Baseline to a less severe category is reported.
Measured: Baseline and Weeks 2, 4, 8, 12, 16 and 24
Percentage of Participants Achieving a PASI 50 Response
The percentage of participants with a ≥ 50% reduction (improvement) in Psoriasis Area and Severity Index (PASI) score from Baseline. PASI is a combination of the intensity of psoriasis, assessed by the erythema (reddening), induration (plaque thickness) and desquamation (scaling) on a scale from no symptoms (0), slight (1), moderate (2), marked (3) or very marked (4), together with the percentage of the area affected, rated on a scale from 0 to 6. PASI scoring is performed at four body areas, the head, arms, trunk, and legs. The total PASI score ranges from 0 to 72. The higher the total score, the more severe the disease.
Measured: Baseline and Weeks 2, 4, 8, 12, 16, and 24
Percentage of Participants Achieving a PASI 75 Response
The percentage of participants with a ≥ 75% reduction (improvement) in Psoriasis Area and Severity Index (PASI) score from Baseline. PASI is a combination of the intensity of psoriasis, assessed by the erythema (reddening), induration (plaque thickness) and desquamation (scaling) on a scale from no symptoms (0), slight (1), moderate (2), marked (3) or very marked (4), together with the percentage of the area affected, rated on a scale from 0 to 6. PASI scoring is performed at four body areas, the head, arms, trunk, and legs. The total PASI score ranges from 0 to 72. The higher the total score, the more severe the disease.
Measured: Baseline and Weeks 2, 4, 8, 12, and 16
Percentage of Participants Achieving a PASI 90 Response
The percentage of participants with a ≥ 90% reduction (improvement) in Psoriasis Area and Severity Index (PASI) score from Baseline. PASI is a combination of the intensity of psoriasis, assessed by the erythema (reddening), induration (plaque thickness) and desquamation (scaling) on a scale from no symptoms (0), slight (1), moderate (2), marked (3) or very marked (4), together with the percentage of the area affected, rated on a scale from 0 to 6. PASI scoring is performed at four body areas, the head, arms, trunk, and legs. The total PASI score ranges from 0 to 72. The higher the total score, the more severe the disease.
Measured: Baseline and Weeks 2, 4, 8, 12, 16, and 24
Percentage of Participants Achieving a PASI 100 Response
The percentage of participants with a 100% reduction (improvement) in Psoriasis Area and Severity Index (PASI) score from Baseline. PASI is a combination of the intensity of psoriasis, assessed by the erythema (reddening), induration (plaque thickness) and desquamation (scaling) on a scale from no symptoms (0), slight (1), moderate (2), marked (3) or very marked (4), together with the percentage of the area affected, rated on a scale from 0 to 6. PASI scoring is performed at four body areas, the head, arms, trunk, and legs. The total PASI score ranges from 0 to 72. The higher the total score, the more severe the disease.
Measured: Baseline and Weeks 2, 4, 8, 12, 16, and 24
Percent Change From Baseline in Psoriasis Area and Severity Index (PASI) Score
PASI is a combination of the intensity of psoriasis, assessed by the erythema (reddening), induration (plaque thickness) and desquamation (scaling) on a scale from no symptoms (0), slight (1), moderate (2), marked (3) or very marked (4), together with the percentage of the area affected, rated on a scale from 0 to 6. PASI scoring is performed at four body areas, the head, arms, trunk, and legs. The total PASI score ranges from 0 to 72. The higher the total score, the more severe the disease.
Change from Baseline is presented as a percentage of the Baseline value: Post-baseline value - Baseline value / Baseline value * 100. A negative change from Baseline indicates improvement.
Measured: Baseline and Weeks 2, 4, 8, 12, 16, and 24
Percent Change From Baseline in Dermatology Life Quality Index (DLQI)
The DLQI questionnaire asks participants to evaluate the degree that psoriasis has affected their quality of life in the last week, and includes the following parameters: symptoms and feelings, daily activities, leisure activities, work or school activities, personal relationships and treatment related feelings. Participants answer 10 questions on a scale from 0 (not at all) to 3 (very much); the range of the total score is 0 to 30. A score of 21 to 30 means an extremely large effect on the participant's life whereas 0-1 means that the disease has no effect at all. Change from Baseline is presented as a percentage of the Baseline value: Post-baseline value - Baseline value / Baseline value * 100. A negative change from Baseline indicates improvement.
Measured: Baseline and Weeks 8, 12, and 24
Percent Change From Baseline in Nail Psoriasis Severity Index (NAPSI)
NAPSI grades nails for both nail matrix psoriasis and nail bed psoriasis. The most affected fingernail was determined at Baseline and used for the analysis.
Nail matrix psoriasis consists of any of the following: pitting, leukonychia, red spots in the lunula, or nail plate crumbling. Nail bed psoriasis is the presence or absence of onycholysis, splinter hemorrhages, oil drop (salman patch) discoloration or nail bed hyperkeratosis. Scoring for each is based on the following scale:
- 0 = none;
- 1 = present in 1/4 nail quadrants;
- 2 = present in 2/4 nail quadrants;
- 3 = present in 3/4 nail quadrants;
- 4 = present in 4/4 nail quadrants.
The sum of these two scores is the total score for the nail, and ranges from 0 (no nail psoriasis) to 8 (psoriasis in 4/4 nail quadrants). Change from Baseline is presented as a percentage of the Baseline value, calculated as: Week 24 value - Baseline value / Baseline value * 100. A negative change from Baseline indicates improvement.
Measured: Baseline and Week 24
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Jul 2012 (estimated)
- Study startMay 2012
- Primary completionSep 2013
- Study completionSep 2013
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.
- Other trials for Moderate to Severe Plaque 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- AbbVie (prior sponsor, Abbott)
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Martin Okun, MD, Study director, AbbVie
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01644396
- Sponsor's protocol ID
- M13-279
- Status last verified
- Sep 2014
- First submitted
- 7 May 2012
- Last updated
- 1 Oct 2014
- Results posted
- Yes, on ClinicalTrials.gov
Study at a glance
From the registry record, last updated by the sponsor on 1 Oct 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open-Label, Prospective Study to Assess the Safety and Effectiveness of Adalimumab (Humira®) in Patients With Moderate to Severe Plaque Psoriasis in the Russian Federation
- ClinicalTrials.gov ID
- NCT01644396
- Acronym / sponsor ID
- M13-279
- Conditions
- Moderate to Severe Plaque Psoriasis
- Keywords
- Moderate to Severe Plaque Psoriasis
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- AbbVie (prior sponsor, Abbott)Industry (pharma, biotech, devices)
- Study start
- May 2012
- Primary completion
- Sep 2013 (actual)
- Study completion
- Sep 2013 (actual)
- First posted
- 19 Jul 2012 (estimated)
- Results
- Posted 17 Sep 2014
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This is an open-label study designed to establish the safety and effectiveness of adalimumab in the treatment of moderate to severe plaque psoriasis after 24 weeks of treatment.
Detailed description
During the treatment period, participants will receive an initial adalimumab 80 milligram (mg) subcutaneous (sc) dose, followed by adalimumab 40 mg sc every other week starting one week after initial dose. Safety and effectiveness assessments will be completed at Baseline, Week 2, Week 4, Week 8, Week 12, Week 16 and Week 24. Participants may discontinue adalimumab treatment at any time during study participation. Participants that end study participation early will have a Premature Discontinuation visit. All participants who do not initiate commercial Humira® will have a follow-up phone call 70 days after the last administration of study drug to obtain information on any new or ongoing Adverse Events (AEs). The 70-day follow-up phone call will not be required for any participant that initiates adalimumab therapy not supplied in the context of the clinical trial after the end of study participation.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Adalimumab | Other | Biological: AdalimumabParticipants received an initial adalimumab 80 mg subcutaneous dose, followed by adalimumab 40 mg subcutaneous every other week starting one week after the initial dose for up to 24 weeks. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- A patient will be eligible for study participation if he/she meets the following criteria:
- Male and female patients ≥ 18 years of age.
- Clinical diagnosis of psoriasis for at least 6 months as determined by patient interview of his/her medical history and confirmation of diagnosis through physical examination by the investigator.
- Stable plaque psoriasis for at least 2 months before Screening and Baseline visits as determined by patient interview of his/her medical history.
- Moderate to severe plaque psoriasis defined by ≥ 10% Body Surface Area (BSA) involvement at the Baseline visit.
Key exclusion criteria (8 listed)
- Diagnosis of erythrodermic psoriasis, pustular psoriasis, medication induced or medication-exacerbated psoriasis or new onset of guttate psoriasis.
- Diagnosis of other active skin diseases or skin infections (bacterial, fungal, or viral) that may interfere with evaluation of psoriasis.
- Patient who cannot discontinue topical therapies for the treatment of psoriasis such as corticosteroids, vitamin D analogs, or retinoids at least 14 days prior to the Baseline (Week 0) visit and during the study. Participants are allowed to use:
- Patient who cannot avoid UVB (Ultraviolet-B) phototherapy for at least 14 days prior to the Baseline (Week 0) visit and during the study.
- Patient who cannot avoid PUVA (psoralen + ultraviolet A) phototherapy for at least 28 days prior to the Baseline (Week 0) visit and during the study.
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 |
|---|---|---|
| AdalimumabAlso: ABT-D2E7, Humira | Biological | Adalimumab |
Primary outcome
Percentage of Participants Achieving a Psoriasis Area and Severity Index 75 (PASI 75) Response at Week 24
Time frame: Baseline and Week 24
The percentage of participants with a ≥ 75% reduction (improvement) in Psoriasis Area and Severity Index (PASI) score from Baseline. PASI is a combination of the intensity of psoriasis, assessed by the erythema (reddening), induration (plaque thickness) and desquamation (scaling) on a scale from no symptoms (0), slight (1), moderate (2), marked (3) or very marked (4), together with the percentage of the area affected, rated on a scale from 0 to 6. PASI scoring is performed at four body areas, the head, arms, trunk, and legs. The total PASI score ranges from 0 to 72. The higher the total score, the more severe the disease.
10 secondary outcomes
Percentage of Participants Achieving a Physician's Global Assessment of Clear
Time frame: Weeks 2, 4, 8, 12, 16 and 24
Percentage of Participants Achieving a Physician's Global Assessment of Clear or Minimal
Time frame: Weeks 2, 4, 8, 12, 16 and 24
Percentage of Participants Achieving a One Grade Improvement in Physician's Global Assessment (PGA)
Time frame: Baseline and Weeks 2, 4, 8, 12, 16 and 24
Percentage of Participants Achieving a PASI 50 Response
Time frame: Baseline and Weeks 2, 4, 8, 12, 16, and 24
Percentage of Participants Achieving a PASI 75 Response
Time frame: Baseline and Weeks 2, 4, 8, 12, and 16
Percentage of Participants Achieving a PASI 90 Response
Time frame: Baseline and Weeks 2, 4, 8, 12, 16, and 24
Percentage of Participants Achieving a PASI 100 Response
Time frame: Baseline and Weeks 2, 4, 8, 12, 16, and 24
Percent Change From Baseline in Psoriasis Area and Severity Index (PASI) Score
Time frame: Baseline and Weeks 2, 4, 8, 12, 16, and 24
Percent Change From Baseline in Dermatology Life Quality Index (DLQI)
Time frame: Baseline and Weeks 8, 12, and 24
Percent Change From Baseline in Nail Psoriasis Severity Index (NAPSI)
Time frame: Baseline and Week 24
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Oct 2014.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Related InfoLink 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
AbbVie
7 sites in 1 country: 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 Moderate to Severe Plaque Psoriasis, run by AbbVie (prior sponsor, Abbott) at 7 sites in Russia.
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 6 inclusion and 8 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 Oct 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 7 sites in Russia. 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. 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 17 Sep 2014). 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?
Percentage of Participants Achieving a Psoriasis Area and Severity Index 75 (PASI 75) Response at Week 24 (time frame: Baseline and Week 24). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 Oct 2014.