Psoriatic Arthritis
Conditions
Keywords
Psoriatic Arthritis, Skin Disease, Joint Disease
Brief summary
The purpose of the study was to compare the efficacy of 2 different Etanercept regimens for the treatment of skin and joint manifestations of psoriatic arthritis.
Interventions
DRUGetanercept
DRUGPlacebo
Sponsors
Wyeth is now a wholly owned subsidiary of Pfizer
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
Inclusion Criteria: * 18 years of age or older at time of consent * Active Psoriatic Arthritis * Clinically stable, plaque psoriasis involving more than 10% of the body surface area
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Patients Achieving Clear or Almost Clear on Physician Global Assessment (PGA) of Psoriasis | 12 weeks | The PGA of Psoriasis scale ranges from 0 (no psoriasis) to 5 (severe disease). Clear and Almost Clear includes all patients who were scored as a 0 or 1. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number of Patients Achieving Psoriatic Arthritis Response Criteria (PsARC) | 12 and 24 weeks | The PsARC response was defined as improvement in at least 2 of the four criteria: \>=30% decrease in swollen joint count, \>=30% decrease in tender joint count, \>=20% improvement in patient's Global Assessment of Disease Activity (arthritis) using VAS (0-100 mm, 0=excellent and 100= poor), \>=20% improvement in physician's Global Assessment of Disease Activity using VAS (VAS: 0-100 mm, 0=no arthritis activity and 100=extremely active arthritis), and at least one of the 2 joint criteria with no deterioration in the other criteria. |
Countries
Argentina, Australia, Austria, Belgium, Colombia, Czechia, Denmark, Finland, France, Germany, Greece, Hungary, Italy, Mexico, Netherlands, Poland, Portugal, Saudi Arabia, Serbia and Montenegro, South Korea, Spain, Sweden, Switzerland, Taiwan, Turkey (Türkiye), United Kingdom
Participant flow
Recruitment details
Subjects were recruited worldwide from December 2005 to September 2007.
Pre-assignment details
Subjects were screened up to 4 weeks.
Participants by arm
| Arm | Count |
|---|---|
| Etanercept BIW/QW Period 1 (Double blind): etanercept 50mg bi-weekly (BIW) for weeks 1-12. Period 2 (Open Label): etanercept 50mg weekly (QW) for weeks 13-24. | 379 |
| Etanercept QW/QW Period 1 (Double blind): etanercept 50mg weekly (QW) with matching placebo for weeks 1-12. Period 2 (Open Label): etanercept 50mg weekly (QW) for weeks 13-24. | 373 |
| Total | 752 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Period 1 (Double Blind): 1-12 Weeks | Adverse Event | 6 | 7 |
| Period 1 (Double Blind): 1-12 Weeks | Pregnancy | 0 | 1 |
| Period 1 (Double Blind): 1-12 Weeks | Protocol Violation | 3 | 0 |
| Period 1 (Double Blind): 1-12 Weeks | Unsatisfactory Response | 2 | 1 |
| Period 1 (Double Blind): 1-12 Weeks | Withdrawal by Subject | 2 | 2 |
| Period 1 (Double Blind): 1-12 Weeks | Withdrawal of consent | 2 | 0 |
| Period 2 (Open Label): 13-24 Weeks | Adverse Event | 8 | 4 |
| Period 2 (Open Label): 13-24 Weeks | Lost to Follow-up | 2 | 2 |
| Period 2 (Open Label): 13-24 Weeks | Protocol Violation | 1 | 3 |
| Period 2 (Open Label): 13-24 Weeks | Unsatisfactory Response | 2 | 5 |
| Period 2 (Open Label): 13-24 Weeks | Withdrawal by Subject | 1 | 3 |
| Period 2 (Open Label): 13-24 Weeks | Withdrawal of consent | 0 | 1 |
Baseline characteristics
| Characteristic | Etanercept BIW/QW | Etanercept QW/QW | Total |
|---|---|---|---|
| Age, Continuous | 46.11 years STANDARD_DEVIATION 11.39 | 46.93 years STANDARD_DEVIATION 11.41 | 46.52 years STANDARD_DEVIATION 11.4 |
| Sex: Female, Male Female | 136 Participants | 143 Participants | 279 Participants |
| Sex: Female, Male Male | 243 Participants | 230 Participants | 473 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 213 / — | 190 / — |
| serious Total, serious adverse events | 15 / — | 11 / — |
Outcome results
Primary
Number of Patients Achieving Clear or Almost Clear on Physician Global Assessment (PGA) of Psoriasis
The PGA of Psoriasis scale ranges from 0 (no psoriasis) to 5 (severe disease). Clear and Almost Clear includes all patients who were scored as a 0 or 1.
Time frame: 12 weeks
Population: The analysis population was the Modified Intent to Treat (mITT) population which includes all randomized patients who received ≥ 1 dose of study drug and had at least 1 post baseline efficacy evaluation. Last observation carried forward (LOCF) approach used for missing data imputation.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Etanercept BIW/QW | Number of Patients Achieving Clear or Almost Clear on Physician Global Assessment (PGA) of Psoriasis | 176 participants |
| Etanercept QW/QW | Number of Patients Achieving Clear or Almost Clear on Physician Global Assessment (PGA) of Psoriasis | 119 participants |
Secondary
Number of Patients Achieving Psoriatic Arthritis Response Criteria (PsARC)
The PsARC response was defined as improvement in at least 2 of the four criteria: \>=30% decrease in swollen joint count, \>=30% decrease in tender joint count, \>=20% improvement in patient's Global Assessment of Disease Activity (arthritis) using VAS (0-100 mm, 0=excellent and 100= poor), \>=20% improvement in physician's Global Assessment of Disease Activity using VAS (VAS: 0-100 mm, 0=no arthritis activity and 100=extremely active arthritis), and at least one of the 2 joint criteria with no deterioration in the other criteria.
Time frame: 12 and 24 weeks
Population: The analysis population was the Modified Intent to Treat (mITT) population which includes all randomized patients who received ≥ 1 dose of study drug and had at least 1 post baseline efficacy evaluation. Last observation carried forward (LOCF) approach used for missing data imputation.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Etanercept BIW/QW | Number of Patients Achieving Psoriatic Arthritis Response Criteria (PsARC) | At 12 Weeks | 284 participants |
| Etanercept BIW/QW | Number of Patients Achieving Psoriatic Arthritis Response Criteria (PsARC) | At 24 Weeks | 303 participants |
| Etanercept QW/QW | Number of Patients Achieving Psoriatic Arthritis Response Criteria (PsARC) | At 12 Weeks | 282 participants |
| Etanercept QW/QW | Number of Patients Achieving Psoriatic Arthritis Response Criteria (PsARC) | At 24 Weeks | 299 participants |