Trial · NCT00574249
Adalimumab in Combination With Topical Treatment (Calcipotriol/Betamethasone) in Subjects With Moderate to Severe Psoriasis and Insufficient Response to Classic Systemic Treatment
NCT00574249, Phase 3, Completed, Abbott; results first posted 2010-01-18
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. Adalimumab in Combination With Topical Treatment (Calcipotriol/Betamethasone) in Subjects With Moderate to Severe Psoriasis and Insufficient Response to Classic Systemic Treatment. Trials, record NCT00574249. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00574249
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Adalimumab in Combination With Topical Treatment (Calcipotriol/Betamethasone) in Subjects With Moderate to Severe Psoriasis and Insufficient Response to Classic Systemic Treatment
- NCT number
- NCT00574249
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 730 participants, actual
- Lead sponsor
- Abbott
- Conditions
- Chronic Plaque Psoriasis
- Interventions
- adalimumab, Calcipotriol/Betamethasone Ointment, placebo (vehicle ointment)
- First posted
- 2007-12-17
- Last updated
- 2011-04-13
- Results first posted
- 2010-01-18
Source ClinicalTrials.gov
Registered outcomes18
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Percentage of Participants Who Achieve a PASI75 Response at Week 16 Compared With Baseline (Week 0) | Week 0 and Week 16 | PASI75 is defined as at least a 75% reduction in PASI (Psoriasis Area and Severity Index) score compared with the Baseline PASI score. PASI scores range from 0.0 (best) to 72.0 (worst), with the highest score representing complete erythroderma of the severest degree. The percent decrease in score is calculated as (Week 0 PASI score minus Week 16 PASI score) divided by Week 0 PASI score. Positive percent decreases indicate improvement, with best improvement being 100%. The outcome measure is the percentage of participants who had at least a 75% PASI score decrease. |
| Secondary | Percentage of Participants With a PASI50 Response at Week 16 Compared With Baseline (Week 0) | Week 0 and Week 16 | PASI50 is defined as at least a 50% reduction in PASI (Psoriasis Area and Severity Index) score compared with the Baseline PASI score. PASI scores range from 0.0 (best) to 72.0 (worst), with the highest score representing complete erythroderma of the severest degree. The percent decrease in score is calculated as (Week 0 PASI score minus Week 16 PASI score) divided by Week 0 PASI score. Positive percent decreases indicate improvement, with best improvement 100%. The outcome measure is the percentage of participants who had at least a 50% PASI score decrease. |
| Secondary | Percentage of Participants With a PASI90 Response at Week 16 Compared With Baseline (Week 0) | Week 0 and Week 16 | PASI90 is defined as at least a 90% reduction in PASI (Psoriasis Area and Severity Index) score compared with the Baseline PASI score. PASI scores range from 0.0 (best) to 72.0 (worst), with the highest score representing complete erythroderma of the severest degree. The percent decrease in score is calculated as (Week 0 PASI score minus Week 16 PASI score) divided by Week 0 PASI score. Positive percent decreases indicate improvement, with best improvement 100%. The outcome measure is the percentage of participants who had at least a 90% PASI score decrease. |
| Secondary | Percentage of Participants With a PASI100 Response at Week 16 Compared With Baseline (Week 0) | Week 0 and Week 16 | PASI100 is defined as at least a 100% reduction in PASI (Psoriasis Area and Severity Index) score compared with the Baseline PASI score. PASI scores range from 0.0 (best) to 72.0 (worst) with the highest score representing complete erythroderma of the severest degree. The percent decrease in score is calculated as (Week 0 PASI score minus Week 16 PASI score) divided by Week 0 PASI score. Positive percent decreases indicate improvement, with best improvement 100%. The outcome measure is the percentage of participants who had at least a 100% PASI score decrease. |
| Secondary | Percentage of Participants Achieving a Physician's Global Assessment (PGA) of Clear or Minimal at Week 2 | Week 2 | PGA is a physician's assessment of severity of disease (grading lesion severity). PGA scores range from 0 (best) to 6 (worst): on the 6-point scale, a score of 0 = Clear and a score of 6 = Very Severe for the lesion severity. PGA Clear (0) is no plaque elevation over normal skin and no scale with or without erythema. Minimal (1) is possible plaque elevation but difficult to ascertain a slight elevation above normal skin. Percentage of participants: 0% to 100% (best). |
| Secondary | Percentage of Participants Achieving a Physician's Global Assessment (PGA) of Clear or Minimal at Week 4 | Week 4 | PGA is a physician's assessment of severity of disease (grading lesion severity). PGA scores range from 0 (best) to 6 (worst): on the 6-point scale, a score of 0 = Clear and a score of 6 = Very Severe for the lesion severity. PGA Clear (0) is no plaque elevation over normal skin and no scale with or without erythema. Minimal (1) is possible plaque elevation but difficult to ascertain a slight elevation above normal skin. Percentage of participants: 0% to 100% (best). |
| Secondary | Percentage of Participants Achieving a Physician's Global Assessment (PGA) of Clear or Minimal at Week 8 | Week 8 | PGA is a physician's assessment of severity of disease (grading lesion severity). PGA scores range from 0 (best) to 6 (worst): on the 6-point scale, a score of 0 = Clear and a score of 6 = Very Severe for the lesion severity. PGA Clear (0) is no plaque elevation over normal skin and no scale with or without erythema. Minimal (1) is possible plaque elevation but difficult to ascertain a slight elevation above normal skin. Percentage of participants: 0% to 100% (best). |
| Secondary | Percentage of Participants Achieving a Physician's Global Assessment (PGA) of Clear or Minimal at Week 12 | Week 12 | PGA is a physician's assessment of severity of disease (grading lesion severity). PGA scores range from 0 (best) to 6 (worst): on the 6-point scale, a score of 0 = Clear and a score of 6 = Very Severe for the lesion severity. PGA Clear (0) is no plaque elevation over normal skin and no scale with or without erythema. Minimal (1) is possible plaque elevation but difficult to ascertain a slight elevation above normal skin. Percentage of participants: 0% to 100% (best). |
| Secondary | Percentage of Participants Achieving a Physicians Global Assessment (PGA) Response of Clear or Minimal at Week 16 | Week 16 | PGA is a physician's assessment of severity of disease (grading lesion severity). PGA scores range from 0 (best) to 6 (worst): on the 6-point scale, a score of 0 = Clear and a score of 6 = Very Severe for the lesion severity. PGA Clear (0) is no plaque elevation over normal skin and no scale with or without erythema. Minimal (1) is possible plaque elevation but difficult to ascertain a slight elevation above normal skin. Percentage of participants: 0% to 100% (best). |
| Secondary | Percent Change From Baseline in the Dermatology Life Quality Index (DLQI) Total Score at Week 16 Compared With Baseline (Week 0) | Week 0 and Week 16 | DLQI is a participant-reported outcome consisting of a set of 10 questions regarding the degree to which (i.e., how much) the subject's skin has affected certain behaviors and quality of life over the last week. Responses to each are: very much, a lot, a little, or not at all. Total score range: 0 (best) to 30 (worst). Negative change and percent change from Baseline indicate improvement, with best improvement -100%. |
1 to 10 of 18Source ClinicalTrials.gov
See all 18 registered outcomesOutcomes18
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Percentage of Participants Who Achieve a PASI75 Response at Week 16 Compared With Baseline (Week 0) | Week 0 and Week 16 | ITT analysis; participants with a missing PASI assessment at Week 16 were imputed as nonresponders. | percentage of participants | NUMBER |
| SECONDARY | Percentage of Participants With a PASI50 Response at Week 16 Compared With Baseline (Week 0) | Week 0 and Week 16 | ITT analysis; participants with a missing PASI assessment at Week 16 were imputed as nonresponders. | percentage of participants | NUMBER |
| SECONDARY | Percentage of Participants With a PASI90 Response at Week 16 Compared With Baseline (Week 0) | Week 0 and Week 16 | ITT analysis; participants with a missing PASI assessment at Week 16 were imputed as nonresponders. | percentage of participants | NUMBER |
| SECONDARY | Percentage of Participants With a PASI100 Response at Week 16 Compared With Baseline (Week 0) | Week 0 and Week 16 | ITT analysis; participants with a missing PASI assessment at Week 16 were imputed as nonresponders. | percentage of participants | NUMBER |
| SECONDARY | Percentage of Participants Achieving a Physician's Global Assessment (PGA) of Clear or Minimal at Week 2 | Week 2 | ITT analysis. Imputation of missing values at Week 2 as not achieving PGA of Clear or Minimal. | percentage of participants | NUMBER |
| SECONDARY | Percentage of Participants Achieving a Physician's Global Assessment (PGA) of Clear or Minimal at Week 4 | Week 4 | ITT analysis. Imputation of missing values at Week 4 as not achieving PGA of Clear or Minimal. | percentage of participants | NUMBER |
| OTHER_PRE_SPECIFIED | Percent Change in Psoriasis Scalp Severity Index (PSSI) From Baseline to Week 16. | Week 0 and Week 16 | Of the ITT analysis set, participants with a PSSI score at both Baseline and Week 16. Imputation of missing values using LOCF. Subjects with a zero score at Baseline were not included in analysis of percent change. | percent change in score | MEDIAN |
| OTHER_PRE_SPECIFIED | Percent Change in Nail Psoriasis Severity Index (NAPSI) at Week 16. | Week 0 and Week 16 | Of the ITT analysis set, participants with a NAPSI score at both Baseline and Week 16. Imputation of missing values using LOCF. Subjects with a zero score at Baseline were not included in analysis of percent change. | percent change in score | MEDIAN |
| SECONDARY | Percentage of Participants Achieving a Physician's Global Assessment (PGA) of Clear or Minimal at Week 8 | Week 8 | ITT analysis. Imputation of missing values at Week 8 as not achieving PGA of Clear or Minimal. | percentage of participants | NUMBER |
| SECONDARY | Percentage of Participants Achieving a Physician's Global Assessment (PGA) of Clear or Minimal at Week 12 | Week 12 | ITT analysis. Imputation of missing values at Week 12 as not achieving PGA of Clear or Minimal. | percentage of participants | NUMBER |
1 to 10 of 18Source ClinicalTrials.gov
See all 18 outcomesResults by group36
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Percentage of Participants Who Achieve a PASI75 Response at Week 16 Compared With Baseline (Week 0) | Adalimumab + Placebo | 70.9 | percentage of participants | ||
| Percentage of Participants Who Achieve a PASI75 Response at Week 16 Compared With Baseline (Week 0) | Adalimumab + Calcipotriol/Betamethasone | 64.8 | percentage of participants | ||
| Percentage of Participants With a PASI50 Response at Week 16 Compared With Baseline (Week 0) | Adalimumab + Placebo | 82.7 | percentage of participants | ||
| Percentage of Participants With a PASI50 Response at Week 16 Compared With Baseline (Week 0) | Adalimumab + Calcipotriol/Betamethasone | 80.9 | percentage of participants | ||
| Percentage of Participants With a PASI90 Response at Week 16 Compared With Baseline (Week 0) | Adalimumab + Placebo | 50.3 | percentage of participants | ||
| Percentage of Participants With a PASI90 Response at Week 16 Compared With Baseline (Week 0) | Adalimumab + Calcipotriol/Betamethasone | 38.8 | percentage of participants | ||
| Percentage of Participants With a PASI100 Response at Week 16 Compared With Baseline (Week 0) | Adalimumab + Placebo | 24.2 | percentage of participants | ||
| Percentage of Participants With a PASI100 Response at Week 16 Compared With Baseline (Week 0) | Adalimumab + Calcipotriol/Betamethasone | 15.3 | percentage of participants | ||
| Percentage of Participants Achieving a Physician's Global Assessment (PGA) of Clear or Minimal at Week 2 | Adalimumab + Placebo | 7.1 | percentage of participants | ||
| Percentage of Participants Achieving a Physician's Global Assessment (PGA) of Clear or Minimal at Week 2 | Adalimumab + Calcipotriol/Betamethasone | 13.9 | percentage of participants |
1 to 10 of 36Source ClinicalTrials.gov
See all 36 results by groupParticipant flow6
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Adalimumab + Placebo | 364 | |
| Overall Study | STARTED | Adalimumab + Calcipotriol/Betamethasone | 366 | |
| Overall Study | COMPLETED | Adalimumab + Placebo | 338 | |
| Overall Study | COMPLETED | Adalimumab + Calcipotriol/Betamethasone | 338 | |
| Overall Study | NOT COMPLETED | Adalimumab + Placebo | 26 | |
| Overall Study | NOT COMPLETED | Adalimumab + Calcipotriol/Betamethasone | 28 |
Source ClinicalTrials.gov
Adverse events94
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 | Diarrhoea | Gastrointestinal disorders | Adalimumab + Placebo | 7 | 364 | |
| other | Diarrhoea | Gastrointestinal disorders | Adalimumab + Calcipotriol/Betamethasone | 11 | 366 | |
| other | Nausea | Gastrointestinal disorders | Adalimumab + Placebo | 5 | 364 | |
| other | Nausea | Gastrointestinal disorders | Adalimumab + Calcipotriol/Betamethasone | 12 | 366 | |
| other | Asthenia | General disorders | Adalimumab + Placebo | 2 | 364 | |
| other | Asthenia | General disorders | Adalimumab + Calcipotriol/Betamethasone | 8 | 366 | |
| other | Fatigue | General disorders | Adalimumab + Placebo | 9 | 364 | |
| other | Fatigue | General disorders | Adalimumab + Calcipotriol/Betamethasone | 8 | 366 | |
| other | Injection site pain | General disorders | Adalimumab + Placebo | 8 | 364 | |
| other | Injection site pain | General disorders | Adalimumab + Calcipotriol/Betamethasone | 3 | 366 |
1 to 10 of 94Source ClinicalTrials.gov
See all 94 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Adalimumab + Placebo | ||
| Total, all-cause mortality | Adalimumab + Calcipotriol/Betamethasone | ||
| Total, other adverse events | Adalimumab + Placebo | 124 | 364 |
| Total, other adverse events | Adalimumab + Calcipotriol/Betamethasone | 136 | 366 |
| Total, serious adverse events | Adalimumab + Placebo | 15 | 364 |
| Total, serious adverse events | Adalimumab + Calcipotriol/Betamethasone | 16 | 366 |
Source ClinicalTrials.gov
Papers1
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as |
|---|---|
| 23178916 | DERIVED |
Source PubMed
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 comparisons1
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison |
|---|
| Adalimumab + Placebo vs Adalimumab + Calcipotriol/Betamethasone: serious adverse events |
Source Trial comparisons
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/NCT00574249
GET https://conductscience.org/api/trials/v1/NCT00574249/results?page=2