Clinical trial · Interventional

Open-label Study of the Safety and Efficacy of Adalimumab in the Treatment of Hidradenitis Suppurativa

A Phase 3, Open-Label Study of the Safety and Efficacy of Adalimumab in Subjects With Moderate to Severe Hidradenitis Suppurativa - PIONEER (Open-Label Extension)

NCT01635764CI-TRIAL-00031349PIONEER (OLE)completedPhase 3Results postedClinicalTrials.gov clinicaltrialsPublishedExplore in graph →

Summary

Brief summary (as posted)

The purpose of this study to evaluate the long term safety, tolerability and efficacy of adalimumab in subjects with moderate to severe hidradenitis suppurativa (HS).

Conditions

Conditions (1)

Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.

Condition (as posted)	Mapped entity	Match	Confidence
Hidradenitis Suppurativa	—	UNRESOLVED	—

Interventions

Interventions (1)

Intervention	Type	Mapped drug	Match
adalimumab	Biological	—	UNRESOLVED

Design

Arms and outcomes

Arms (1)

type
EXPERIMENTAL
label
Adalimumab Every Week
description
Adalimumab 40 mg every week.
interventionNames
1. Biological: adalimumab

Primary outcomes (15)

measure
Percentage of Participants in the EW/EW/EW, EW/EOW/EW, and EW/PBO/EW Analysis Populations Achieving Clinical Response Per Hidradenitis Suppurativa Clinical Response (HiSCR) at Each Visit
timeFrame
Weeks 2 (first dose of adalimumab in prior phase 3 study), 4, 8, 12, 16, 20, 24, 36, 48, 60, 72, 84, 96, 108, 120, 132, 144, 156, 168, 180, 192, 204, and 216
description
Clinical response per HiSCR defined as percent reduction from baseline of the prior phase 3 study in the abscess and inflammatory nodule ≥ 50% (AN50) with no increase in the abscess count and no increase in the draining fistula count. Last Observation Carried Forward (LOCF): The last completed evaluation from the previous visit was carried forward to impute missing data at later visits.
measure

Eligibility

Eligibility (as posted)

Sex: All
Minimum age: 18 Years

Show eligibility criteria text

Inclusion Criteria:

* Subjects who previously participated in a prior Phase 3 AbbVie hidradenitis suppurativa (HS) study (M11-313 or M11-810) and:

  1. Completed the study; or
  2. Experienced a loss of response (LOR); or
  3. Experienced worsening or absence of improvement

     Exclusion Criteria:
* Prior treatment with any other anti-tumour necrosis factor (anti-TNF) therapy (e.g., infliximab, etanercept), or participation in an adalimumab trial other than a prior Phase 3 AbbVie HS study.
* Subject received any oral antibiotic treatment for HS within 28 days prior to the Baseline visit, except for antibiotics permitted in a prior Phase 3 AbbVie HS study.
* Subject received prescription topical therapies for the treatment of HS within 14 days prior to the Baseline visit of Study M12-555.

References

Publications (0)

Data not yet available

No reference posted for this study.