Trial · NCT01468207
Efficacy and Safety Study of Adalimumab in Treatment of Hidradenitis Suppurativa
NCT01468207, Phase 3, Completed, AbbVie (prior sponsor, Abbott); results first posted 2015-10-28
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. Efficacy and Safety Study of Adalimumab in Treatment of Hidradenitis Suppurativa. Trials, record NCT01468207. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01468207
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Efficacy and Safety Study of Adalimumab in Treatment of Hidradenitis Suppurativa
- NCT number
- NCT01468207
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 307 participants, actual
- Lead sponsor
- AbbVie (prior sponsor, Abbott)
- Conditions
- Hidradenitis Suppurativa (HS)
- Interventions
- adalimumab, placebo
- First posted
- 2011-11-09
- Last updated
- 2021-07-07
- Other registries' IDs
- eudract:2011-003400-20
- Results first posted
- 2015-10-28
Source ClinicalTrials.gov
Registered outcomes4
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Percentage of Participants Achieving Hidradenitis Suppurativa Clinical Response (HiSCR) at Week 12 | Baseline (Week 0) up to Week 12 | HiSCR was defined as at least a 50% reduction in abscess and inflammatory nodule (AN) count with no increase in abscess count and no increase in draining fistula count at Week 12 relative to Baseline. Data are presented for all participants and by baseline Hurley Stage (Stage 1: Abscess formation, single or multiple, without sinus tracts and scarring; Stage II: One or more widely separated recurrent abscesses with tract formation and scars. A participant with at least 1 anatomic region with Hurley Stage II disease and with no anatomic regions with Hurley Stage III disease was classified as Hurley Stage II; and Stage III: Multiple interconnected tracts and abscesses across the entire area, with diffuse or near diffuse involvement. A participant with at least 1 anatomic region with Hurley Stage III disease was classified as Hurley Stage III). Non-responder imputation (NRI): Participants with missing data were considered non-responders. |
| Secondary | Percentage of Participants With Baseline Hurley Stage II Who Achieved Abscess and Inflammatory Nodule (AN) Count of 0, 1, or 2 at Week 12 | Baseline (Week 0) up to Week 12 | The percentage of participants with AN counts lowered to 0, 1, or 2 at Week 12 among participants with Hurley Stage II at Baseline. NRI: Participants with missing data were considered non-responders. |
| Secondary | Percentage of Participants Achieving At Least 30% Reduction and At Least 1 Unit Reduction From Baseline in Patient's Global Assessment of Skin Pain (NRS30) - At Worst at Week 12 Among Participants With Baseline Skin Pain NRS ≥ 3 | Baseline (Week 0) up to Week 12 | The Patient's Global Assessment of Skin Pain Numeric Rating Scale (NRS) was used to assess the worst skin pain and the average skin pain due to HS. Ratings for the 2 items range from 0 (no skin pain) to 10 (skin pain as bad as you can imagine). The assessments were completed on a daily diary by participants before they went to bed and responded to the items based on a recall period of the "last 24 hours." The percentage of participants who achieved at least 30% reduction and at least 1 unit reduction from Baseline in the Patient's Global Assessment of Skin Pain (NRS30) - at worst at Week 12 among participants with Baseline NRS ≥ 3 are presented. Weekly averages of daily assessments were analyzed. NRI: Participants with missing data were considered non-responders. |
| Secondary | Change From Baseline to Week 12 in Modified Sartorius Score | Baseline (Week 0) and Week 12 | The Sartorius Scale is used to quantify the severity of HS. Points are awarded for 12 body areas (left and right axillae, left and right sub/inframammary areas, intermammary area, left and right buttocks, left and right inguino-crural folds, perianal area, perineal area, and other): points were awarded for nodules (2 points for each); abscesses (4 points); fistulas (4 points); scars (1 point); other findings (1 point); and longest distance between two lesions (2-6 points, 0 if no lesions); and if lesions are separated by normal skin (yes-0 points; No-6 points). The total Sartorius score is the sum of the 12 regional scores. Last Observation Carried Forward (LOCF): The last completed evaluation from the previous visit within the particular period for efficacy measures was carried forward to impute missing data at later visits in the same period. Baseline efficacy evaluations were not carried forward. |
Source ClinicalTrials.gov
Outcomes4
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Percentage of Participants Achieving Hidradenitis Suppurativa Clinical Response (HiSCR) at Week 12 | Baseline (Week 0) up to Week 12 | The intention-to-treat (ITT) population, defined as all participants who were randomized at Baseline (Week 0), was analyzed overall and by baseline Hurley Stage | percentage of participants | NUMBER |
| SECONDARY | Percentage of Participants With Baseline Hurley Stage II Who Achieved Abscess and Inflammatory Nodule (AN) Count of 0, 1, or 2 at Week 12 | Baseline (Week 0) up to Week 12 | Participants in the ITT population with baseline Hurley Stage II | percentage of participants | NUMBER |
| SECONDARY | Percentage of Participants Achieving At Least 30% Reduction and At Least 1 Unit Reduction From Baseline in Patient's Global Assessment of Skin Pain (NRS30) - At Worst at Week 12 Among Participants With Baseline Skin Pain NRS ≥ 3 | Baseline (Week 0) up to Week 12 | Participants in the ITT population with baseline NRS at Worst ≥ 3 | percentage of participants | NUMBER |
| SECONDARY | Change From Baseline to Week 12 in Modified Sartorius Score | Baseline (Week 0) and Week 12 | Participants in the ITT population | units on a scale | LEAST_SQUARES_MEAN |
Source ClinicalTrials.gov
Results by group12
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Percentage of Participants Achieving Hidradenitis Suppurativa Clinical Response (HiSCR) at Week 12 | Placebo | 26.0 | percentage of participants | ||
| Percentage of Participants Achieving Hidradenitis Suppurativa Clinical Response (HiSCR) at Week 12 | Adalimumab Every Week (EW) | 41.8 | percentage of participants | ||
| Percentage of Participants Achieving Hidradenitis Suppurativa Clinical Response (HiSCR) at Week 12 | Placebo - Baseline Hurley Stage II | 29.8 | percentage of participants | ||
| Percentage of Participants Achieving Hidradenitis Suppurativa Clinical Response (HiSCR) at Week 12 | Placebo - Baseline Hurley Stage III | 21.4 | percentage of participants | ||
| Percentage of Participants Achieving Hidradenitis Suppurativa Clinical Response (HiSCR) at Week 12 | Adalimumab Every Week (EW) - Baseline Hurley Stage II | 44.6 | percentage of participants | ||
| Percentage of Participants Achieving Hidradenitis Suppurativa Clinical Response (HiSCR) at Week 12 | Adalimumab Every Week (ew) - Baseline Hurley Stage III | 38.6 | percentage of participants | ||
| Percentage of Participants With Baseline Hurley Stage II Who Achieved Abscess and Inflammatory Nodule (AN) Count of 0, 1, or 2 at Week 12 | Placebo - Baseline Hurley Stage II | 28.6 | percentage of participants | ||
| Percentage of Participants With Baseline Hurley Stage II Who Achieved Abscess and Inflammatory Nodule (AN) Count of 0, 1, or 2 at Week 12 | Adalimumab Every Week (EW) - Baseline Hurley Stage II | 28.9 | percentage of participants | ||
Percentage of Participants Achieving At Least 30% Reduction and At Least 1 Unit Reduction From Baseline in Patient's Global Assessment of Skin Pain (NRS30) - At Worst at Week 12 Among Participants With Baseline Skin Pain NRS ≥ 3 | Placebo - Baseline NRS at Worst ≥ 3 | 24.8 | percentage of participants | ||
Percentage of Participants Achieving At Least 30% Reduction and At Least 1 Unit Reduction From Baseline in Patient's Global Assessment of Skin Pain (NRS30) - At Worst at Week 12 Among Participants With Baseline Skin Pain NRS ≥ 3 | Adalimumab Every Week (EW) - Baseline NRS at Worst ≥ 3 | 27.9 | percentage of participants |
1 to 10 of 12Source ClinicalTrials.gov
See all 12 results by groupParticipant flow42
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Treatment Period 1 | STARTED | Placebo | 154 | |
| Treatment Period 1 | STARTED | Adalimumab Every Week (EW) | 153 | |
| Treatment Period 1 | STARTED | Placebo/Adalimumab Every Week (EW) | 0 | |
| Treatment Period 1 | STARTED | Adalimumab Every Week (EW)/Placebo | 0 | |
| Treatment Period 1 | STARTED | Adalimumab Every Week (EW)/ Adalimumab Every Other Week (EOW) | 0 | |
| Treatment Period 1 | STARTED | Adalimumab Every Week (EW)/Adalimumab Every Week (EW) | 0 | |
| Treatment Period 1 | Received Study Drug | Placebo | 152 | |
| Treatment Period 1 | Received Study Drug | Adalimumab Every Week (EW) | 153 | |
| Treatment Period 1 | Received Study Drug | Placebo/Adalimumab Every Week (EW) | 0 | |
| Treatment Period 1 | Received Study Drug | Adalimumab Every Week (EW)/Placebo | 0 |
1 to 10 of 42Source ClinicalTrials.gov
See all 42 participant flowAdverse events750
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 | ANAEMIA | Blood and lymphatic system disorders | Placebo (Period 1) | 1 | 152 | |
| other | ANAEMIA | Blood and lymphatic system disorders | Adalimumab EW (Period 1) | 1 | 153 | |
| other | ANAEMIA | Blood and lymphatic system disorders | Placebo/Adalimumab EW (Period 2) | 1 | 145 | |
| other | ANAEMIA | Blood and lymphatic system disorders | Adalimumab EW/Placebo (Period 2) | 1 | 49 | |
| other | ANAEMIA | Blood and lymphatic system disorders | Adalimumab EW/Adalimumab EOW (Period 2) | 0 | 48 | |
| other | ANAEMIA | Blood and lymphatic system disorders | Adalimumab EW/Adalimumab EW (Period 2) | 2 | 48 | |
| other | LEUKOCYTOSIS | Blood and lymphatic system disorders | Placebo (Period 1) | 0 | 152 | |
| other | LEUKOCYTOSIS | Blood and lymphatic system disorders | Adalimumab EW (Period 1) | 0 | 153 | |
| other | LEUKOCYTOSIS | Blood and lymphatic system disorders | Placebo/Adalimumab EW (Period 2) | 2 | 145 | |
| other | LEUKOCYTOSIS | Blood and lymphatic system disorders | Adalimumab EW/Placebo (Period 2) | 1 | 49 |
1 to 10 of 750Source ClinicalTrials.gov
See all 750 adverse eventsAdverse event totals18
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Placebo (Period 1) | ||
| Total, all-cause mortality | Adalimumab EW (Period 1) | ||
| Total, all-cause mortality | Placebo/Adalimumab EW (Period 2) | ||
| Total, all-cause mortality | Adalimumab EW/Placebo (Period 2) | ||
| Total, all-cause mortality | Adalimumab EW/Adalimumab EOW (Period 2) | ||
| Total, all-cause mortality | Adalimumab EW/Adalimumab EW (Period 2) | ||
| Total, other adverse events | Placebo (Period 1) | 81 | 152 |
| Total, other adverse events | Adalimumab EW (Period 1) | 64 | 153 |
| Total, other adverse events | Placebo/Adalimumab EW (Period 2) | 68 | 145 |
| Total, other adverse events | Adalimumab EW/Placebo (Period 2) | 30 | 49 |
1 to 10 of 18Source ClinicalTrials.gov
See all 18 adverse event totalsPapers3
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.
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