Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| Celgene | INDUSTRY |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
12 weeks open label with Otezla® and NUVB, followed by 6 month double blind Otezla® (apremilast) or placebo to subjects who obtain PASI 75 at week 12 of phototherapy
Primary Objective: To evaluate the effectiveness of Otezla (apremilast®) in promoting maintenance of response in those subjects who obtained PASI-75 at week 12 of phototherapy.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Apremilast + apremilast | Active Comparator | apremilast 30mg bid for 12 weeks.followed by apremilast 30 mg bid for 24 weeks |
|
| apremilast + placebo | Placebo Comparator | apremilast 30mg bid for 12 weeks followed by placebo bid for 24 weeks |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| apremilast | Drug |
|
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants Maintaining Psoriasis Area Severity Index Score (PASI) 75 at Week 36 | Analysis of Psoriasis Area Severity Index Score at week 36 to determine number of subjects who maintained PASI 75 at week 36 | 36weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Subjects Achieving Psoriasis Area Severity Index Score (PASI) 75 Response at Week 12 | Psoriasis Area Severity Score of 75 or greater at week 12 | 12WEEKS |
| Number of Subjects Achieving Psoriasis Area Severity Index Score 90 at Week 36 |
Not provided
Inclusion Criteria: Subjects must meet the following criteria to be enrolled in this study:
Male or female adult ≥ 18 years of age;
Diagnosis of chronic plaque-type
Moderate to severe plaque type psoriasis as defined at baseline by:
Able and willing to give written informed consent prior to performance of any study-related procedures
Exclusion Criteria:
Subjects who meet any of the following criteria will be excluded from participation in this study:
Forms of psoriasis other than chronic plaque-type (e.g., pustular, erythrodermic, and/or guttate psoriasis) or drug induced psoriasis
Subjects with previous exposure to apremilast
Malignancy or history of malignancy, except for:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Jerry Bagel, MD | Psoriasis Treatment Center of Central New Jersey | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Psoriasis Treatment Center of Central New Jersey | East Windsor | New Jersey | 08520 | United States |
Not provided
Recruitment May 28 2015-November 2015 through practice database
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | Apremilast + Apremilast | apremilast 30 mg BID for 12 weeks + apremilast 30 mg BID through week 36 |
| FG001 | Apremilast + Placebo | apremilast 30 mg BID for 12 weeks + placebo BID through week 36 |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Apremilast + Apremilast | apremilast + apremilast 30mg bid after week 12 |
| BG001 | Apremilast + Placebo | apremilast + Placebo bid after week 12 |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Number of Participants Maintaining Psoriasis Area Severity Index Score (PASI) 75 at Week 36 | Analysis of Psoriasis Area Severity Index Score at week 36 to determine number of subjects who maintained PASI 75 at week 36 | Posted | Number | participants | 36weeks |
|
|
Not provided
Not provided
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Apremilast 30mg BID First 12 Weeks | apremilast 30mg bid for 12 weeks | 0 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| second degree burn | Skin and subcutaneous tissue disorders | burn related NBUVB |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| worsening of psoriasis | Skin and subcutaneous tissue disorders |
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Jerry Bagel Director of Clinical Trials | Psoriasis Treatment Center of Central New Jersey | 6094434500 | dreamacres1@aol.com |
Not provided
| ID | Term |
|---|---|
| C505730 | apremilast |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
PASI 90 or greater at week 36
| 36 weeks |
| Number of Subjects Achieving Physician Global Assessment Score of 0 or 1 at Week 36 | PGA score 0 or 1 | 36 weeks |
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Participants |
|
|
| Secondary | Number of Subjects Achieving Psoriasis Area Severity Index Score (PASI) 75 Response at Week 12 | Psoriasis Area Severity Score of 75 or greater at week 12 | 22 subjects completed week 12 | Posted | Number | participants | 12WEEKS |
|
|
|
| Secondary | Number of Subjects Achieving Psoriasis Area Severity Index Score 90 at Week 36 | PASI 90 or greater at week 36 | Posted | Number | participants | 36 weeks |
|
|
|
| Secondary | Number of Subjects Achieving Physician Global Assessment Score of 0 or 1 at Week 36 | PGA score 0 or 1 | Posted | Number | participants | 36 weeks |
|
|
|
| 29 |
| 1 |
| 29 |
| 13 |
| 29 |
| EG001 | Apremilast 30mg BID After 12 Weeks | apremilast bid after week 12 | 0 | 8 | 0 | 8 | 3 | 8 |
| EG002 | Placebo BID After 12 Weeks | placebo bid after week 12 | 0 | 8 | 1 | 8 | 5 | 8 |
| Arterial rupture right leg | Vascular disorders | arterial rupture during catheterization |
|
| abdominal pain | Gastrointestinal disorders |
|
| bronchitis | Respiratory, thoracic and mediastinal disorders |
|
| First degree burn | Skin and subcutaneous tissue disorders |
|
Not provided
Not provided