Trial · NCT00249808
A Study of Efalizumab in Participants With Moderate to Severe Chronic Psoriasis Who Have Failed, Have a Contraindication to, or Are Intolerant of Other Systemic Therapies
NCT00249808, Phase 4, Completed, Merck KGaA, Darmstadt, Germany; results first posted 2018-03-20
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. A Study of Efalizumab in Participants With Moderate to Severe Chronic Psoriasis Who Have Failed, Have a Contraindication to, or Are Intolerant of Other Systemic Therapies. Trials, record NCT00249808. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00249808
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- A Study of Efalizumab in Participants With Moderate to Severe Chronic Psoriasis Who Have Failed, Have a Contraindication to, or Are Intolerant of Other Systemic Therapies
- NCT number
- NCT00249808
- Status
- Completed
- Phases
- Phase 4
- Enrollment
- 1,266 participants, actual
- Lead sponsor
- Merck KGaA, Darmstadt, Germany
- Conditions
- Psoriasis
- Interventions
- Efalizumab - anti-CD11a recombinant human monoclonal antibody
- First posted
- 2005-11-07
- Last updated
- 2018-03-20
- Results first posted
- 2018-03-20
Source ClinicalTrials.gov
Registered outcomes3
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Percentage of Participants With Physician's Global Assessment (PGA) Ratings of Good or Better (FT) | Week 12 | The PGA assesses the global response of all psoriatic lesions to therapy by comparing the participant's present condition to baseline. PGA response includes: Cleared (100 percent \[%\] improvement; remission of all clinical signs and symptoms, except for residual manifestations such as mild erythema); Excellent (75% to 99% improvement of all clinical signs and symptoms, except for residual manifestations such as mild erythema); Good (50% to 74% improvement of all clinical signs and symptoms); Fair (25% to 49% improvement of all clinical signs and symptoms); Slight (1% to 24% improvement of all clinical signs and symptoms); Unchanged (clinical signs and symptoms unchanged); Worse (clinical signs and symptoms deteriorated). Percentage of participants with PGA ratings of Good or Better (i.e, Good, Excellent or Cleared) are reported. |
| Secondary | Percentage of Participants With Psoriasis Rebound | Up to 8 weeks after end of FT (up to Week 20) | Rebound was defined as worsening of disease as assessed by Psoriasis Area and Severity Index (PASI) score \>125% of baseline or new pustular, erythrodermic, or more inflammatory psoriasis occurring within 2 months of stopping therapy. PASI is an instrument used to assess the extent of cutaneous psoriasis and to measure the effects of therapy. The PASI divides the body into four anatomical regions: head, trunk, upper limbs, and lower limbs. For each region, the evaluator assesses the severity of erythema, induration/thickness and scaling and determines the percentage of the region affected by disease. A numerical PASI score is derived that evaluates the severity of symptoms in terms of the total body surface area affected. Total PASI score ranges from 0 to 72, with higher scores indicating more severe disease. |
| Secondary | Percentage of Participants With Psoriasis Exacerbation | During study (40 weeks) | Exacerbation was defined as disease worsening either during or after treatment which was more inflammatory in nature compared to baseline and occurred either within pre-existing plaques, at previously uninvolved sites, or as new morphologies of disease. |
Source ClinicalTrials.gov
Outcomes3
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Percentage of Participants With Physician's Global Assessment (PGA) Ratings of Good or Better (FT) | Week 12 | ITT population. | percentage of participants | NUMBER |
| SECONDARY | Percentage of Participants With Psoriasis Rebound | Up to 8 weeks after end of FT (up to Week 20) | Observation population included all participants had stopped treatment with efalizumab following the FT (Week 12) and who had responded to treatment during (PGA good or better ) FT. Here, overall number of participants analyzed = participants who were evaluable for this outcome. | percentage of participants | NUMBER |
| SECONDARY | Percentage of Participants With Psoriasis Exacerbation | During study (40 weeks) | ITT population. Here, overall number of participants analyzed = participants who failed to respond (PGA less than good) at Week 12. | percentage of participants | NUMBER |
Source ClinicalTrials.gov
Results by group3
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Percentage of Participants With Physician's Global Assessment (PGA) Ratings of Good or Better (FT) | Efalizumab | 68.0 | 95% Confidence Interval 65.3 to 70.5 | percentage of participants | |
| Percentage of Participants With Psoriasis Rebound | Efalizumab | 11.0 | 65.3 to 70.5 | percentage of participants | |
| Percentage of Participants With Psoriasis Exacerbation | Efalizumab | 12.9 | 65.3 to 70.5 | percentage of participants |
Source ClinicalTrials.gov
Participant flow3
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Efalizumab | 1,266 | |
| Overall Study | COMPLETED | Efalizumab | 1,084 | |
| Overall Study | NOT COMPLETED | Efalizumab | 182 |
Source ClinicalTrials.gov
Adverse events59
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | Headache | Nervous system disorders | Efalizumab | 323 | 1,266 | |
| other | Pyrexia | General disorders | Efalizumab | 121 | 1,266 | |
| other | Influenza Like Illness | General disorders | Efalizumab | 108 | 1,266 | |
| other | Arthralgia | Musculoskeletal and connective tissue disorders | Efalizumab | 71 | 1,266 | |
| serious | Psoriasis | Skin and subcutaneous tissue disorders | Efalizumab | 14 | 1,266 | |
| serious | Erythrodermic Psoriasis | Skin and subcutaneous tissue disorders | Efalizumab | 3 | 1,266 | |
| serious | Dermatitis Allergic | Skin and subcutaneous tissue disorders | Efalizumab | 1 | 1,266 | |
| serious | Dermatitis Exfoliative | Skin and subcutaneous tissue disorders | Efalizumab | 1 | 1,266 | |
| serious | Erythema | Skin and subcutaneous tissue disorders | Efalizumab | 1 | 1,266 | |
| serious | Follicular Mucinosis | Skin and subcutaneous tissue disorders | Efalizumab | 1 | 1,266 |
1 to 10 of 59Source ClinicalTrials.gov
See all 59 adverse eventsAdverse event totals3
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Efalizumab | ||
| Total, other adverse events | Efalizumab | 623 | 1,266 |
| Total, serious adverse events | Efalizumab | 60 | 1,266 |
Source ClinicalTrials.gov
Papers2
The papers the trial lists on ClinicalTrials.gov.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT00249808
GET https://conductscience.org/api/trials/v1/NCT00249808/events?page=2