Efficacy and Safety Study of Adalimumab in Treatment of Hidradenitis Suppurativa (PIONEER I)
This study is currently recruiting participants.
Verified March 2013 by AbbVie
Sponsor:
AbbVie (prior sponsor, Abbott)
Information provided by (Responsible Party):
AbbVie ( AbbVie (prior sponsor, Abbott) )
ClinicalTrials.gov Identifier:
NCT01468207
First received: November 7, 2011
Last updated: March 14, 2013
Last verified: March 2013
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Purpose
A study to evaluate the safety and efficacy of treatment in adults with moderate to severe hidradenitis suppurativa.
| Condition | Intervention | Phase |
|---|---|---|
|
Hidradenitis Suppurativa (HS) |
Biological: adalimumab Biological: placebo |
Phase 3 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Investigator) Primary Purpose: Treatment |
| Official Title: | Clinical Study Protocol M11-313 - PIONEER I A Phase 3 Multicenter Study of the Safety and Efficacy of Adalimumab in Subjects With Moderate to Severe Hidradenitis Suppurativa |
Resource links provided by NLM:
Genetics Home Reference related topics:
hidradenitis suppurativa
MedlinePlus related topics:
Hidradenitis Suppurativa
Drug Information available for:
Adalimumab
U.S. FDA Resources
Further study details as provided by AbbVie:
Primary Outcome Measures:
- Proportion of subjects achieving clinical response at Week 12 [ Time Frame: Baseline (Week 0) up to Week 12 ] [ Designated as safety issue: No ]Subjects improvement in hidradenitis suppurativa severity.
Secondary Outcome Measures:
- Proportion of subjects achieving counts of 0, 1, or 2 at Week 12 [ Time Frame: Baseline (Week 0) up to Week 12 ] [ Designated as safety issue: No ]Subjects counts lowered to 0, 1 or 2 at Week 12 among subjects with Hurley Stage II at Baseline.
- Reduction in patient skin pain assessment at Week 12 [ Time Frame: Baseline (Week 0) up to Week 12 ] [ Designated as safety issue: No ]Proportion of subjects who achieve a reduction, and at least 1 unit reduction from baseline in their skin pain at measured by the Patient's Global Assessment of Skin Pain (NRS30) at Week 12
- Change in Sartorius scale [ Time Frame: Baseline (Week 0) and Week 12 ] [ Designated as safety issue: No ]Change in Sartorius scale from Baseline to Week 12
| Estimated Enrollment: | 300 |
| Study Start Date: | September 2010 |
| Estimated Study Completion Date: | January 2014 |
| Estimated Primary Completion Date: | August 2013 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: adalimumab every week (ew)
adalimumab every week (ew)
|
Biological: adalimumab
Prefilled syringe, adalimumab subcutaneous every week
Other Name: Humira
|
|
Placebo Comparator: placebo
placebo
|
Biological: placebo
Prefilled syringe, placebo every week
|
|
Experimental: adalimumab every other week (eow)
adalimumab every other week (eow)
|
Biological: adalimumab
Prefilled syringe, adalimumab subcutaneous every other week (eow)
Other Name: Humira
|
Detailed Description:
The clinical trial identifier is PIONEER I. The purpose of this study is to evaluate the safety of adalimumab and to determine how well it works in the treatment of adults with moderate to severe hidradenitis suppurativa (HS). HS is a chronic skin disease that creates red, swollen, painful bumps which can break open to combine and form tunnels in the skin and scars. Sometimes these bumps can heal themselves quickly and sometimes they will become much worse and create sores that heal with multiple combined scars, or areas that do not heal. In this study, approximately 300 adults will be enrolled at treatment centers worldwide. Subject participation in this study will be up to 50 weeks. There will be a screening period, which will last from 7 to 30 days, and a study treatment period of up to 36 weeks. Study visits occur at Screening, Baseline, and Weeks 2, 4, 8, 12, 14, 16, 20, 24, 28, 32 and 36 (or sooner if subject leaves the study before Week 36). The study is divided into two treatment periods. The first period (Period A) will last 12 weeks and the second period (Period B) will last up to 24 weeks.
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria:
- Adults must have a diagnosis of hidradenitis suppurativa (HS) for at least 1 year prior to Baseline.
- HS lesions must be present in at least two distinct anatomical areas, one of which must be at least Hurley Stage II or Hurley Stage III.
- Subject must have stable HS for at least 60 days prior to Screening visit and at Baseline visit.
- Subject must have experienced an inadequate response to at least a 90 day treatment of oral antibiotics for treatment of HS.
- Subject must have a count of greater than or equal to 3 at baseline.
Exclusion Criteria:
- Subject was previously treated with adalimumab or another anti-TNF therapy (e.g., infliximab or etanercept).
- Subject received any oral antibiotic treatment for HS within 28 days prior to Baseline.
- Subject received oral concomitant analgesics (including opioids) for HS-related pain within 14 days prior to Baseline visit.
If entering the study on concomitant oral analgesics for non-HS related pain:
- Subject on opioid analgesics within 14 days prior to Baseline visit;
- Subject not on a stable dose of non-opioid oral analgesics for at least 14 days prior to the Baseline visit ("as needed" is not considered a stable dose).
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01468207
Show 49 Study Locations
Contacts
| Contact: Andrea Byars, BS | 847-937-7904 | andrea.byars@abbvie.com |
| Contact: Tiffany Askew, BS | 847-937-9399 | tiffany.askew@abbvie.com |
Show 49 Study LocationsSponsors and Collaborators
AbbVie (prior sponsor, Abbott)
Investigators
| Study Chair: | David Williams, MD | AbbVie |
More Information
Additional Information:
No publications provided
| Responsible Party: | AbbVie ( AbbVie (prior sponsor, Abbott) ) |
| ClinicalTrials.gov Identifier: | NCT01468207 History of Changes |
| Other Study ID Numbers: | M11-313, 2011-003400-20 |
| Study First Received: | November 7, 2011 |
| Last Updated: | March 14, 2013 |
| Health Authority: | United States: Food and Drug Administration Canada: Health Canada Germany: Federal Institute for Drugs and Medical Devices Hungary: Ministry of Health, Social and Family Affairs Czech Republic: State Institute for Drug Control Australia: National Health and Medical Research Council |
Keywords provided by AbbVie:
|
acne psoriasis hidradenitis suppurativa TNF HS PIONEER I |
acne inversa boil placebo controlled Double blind adalimumab |
Additional relevant MeSH terms:
|
Hidradenitis Hidradenitis Suppurativa Sweat Gland Diseases Skin Diseases Skin Diseases, Bacterial Bacterial Infections Skin Diseases, Infectious |
Infection Suppuration Adalimumab Antirheumatic Agents Therapeutic Uses Pharmacologic Actions Anti-Inflammatory Agents |
ClinicalTrials.gov processed this record on May 16, 2013