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Safety and Efficacy of Adalimumab (Humira) for Hidradenitis Suppurativa (HS) Peri-Surgically (SHARPS)

Primary Purpose

Hidradenitis Suppurativa (HS)

Status
Completed
Phase
Phase 4
Locations
International
Study Type
Interventional
Intervention
Placebo
Adalimumab
Sponsored by
AbbVie
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Hidradenitis Suppurativa (HS) focused on measuring Hidradenitis Suppurativa, Axilla, Inguinal region, Hurley Stage I, II, or III, Adalimumab, Secondary intention, Abcess and inflammatory nodule (AN) count

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Participant must have skin lesions that are diagnostic of Hidradenitis Suppurativa (HS) for at least 1 year (365 days) prior to the Baseline visit

  • Participant must have at least 3 distinct anatomical regions involved with inflammatory (also termed 'active') HS lesions; plus

    • either one axilla or one inguinal region (limited to the inguino-crural fold and adjacent areas) that requires excisional surgery, and
    • with at least one of the other affected HS regions (e.g., contralateral inguinal region, buttocks, inframammary region) rated as Hurley Stage II or III
  • Participant must have a total abscess and inflammatory nodule (AN) count of greater than or equal to 3 at the Baseline visit within the HS non-surgical sites
  • The HS surgical site must contain at least one active HS lesion
  • The HS surgical site must require excisional surgery and is large enough to require healing by secondary intention as assessed by the designated surgeon

Exclusion Criteria:

  • Participant has a draining fistula count of greater than 20 at the Baseline visit
  • Participant requires surgery at any anatomical site other than an unilateral axilla or inguinal region site
  • Participant requires surgical management prior to Week 13
  • Participant requires, based on the designated surgeon's assessment, excisional surgery with primary closure as the method of closure being most beneficial for the participant

Sites / Locations

  • Wallace Medical Group, Inc. /ID# 171289
  • Encino Research Center / T. Jo /ID# 171347
  • University of California Irvine /ID# 170054
  • Tulane Univ /ID# 168441
  • Beth Israel Deaconess Medical Center /ID# 168438
  • University of Michigan Hospitals /ID# 200667
  • Univ NC Chapel Hill /ID# 168446
  • Penn State Hershey Medical Ctr /ID# 168447
  • Rhode Island Hospital /ID# 168439
  • CUB Hospital Erasme /ID# 150907
  • UZ Gent /ID# 150906
  • NewLab Clinical Research Inc. /ID# 151315
  • York Dermatology Clinic and Research Centre /ID# 151314
  • Fundacion Valle Del Lili /ID# 151565
  • Hospital Pablo Tobon Uribe /ID# 152693
  • Fakultni nemocnice Ostrava /ID# 169174
  • Fakult Nem Kralovske Vinohrady /ID# 169173
  • Bispebjerg Hospital /ID# 150796
  • Sjaellands Universitets Hospit /ID# 150795
  • Hopital Prive d'Antony /ID# 157347
  • Polyclinique Courlancy /ID# 157761
  • Universitaetsklinikum Erlangen /ID# 167251
  • Charité Universitätsmedizin Campus Mitte /ID# 150875
  • Klinikum Ruhr Univ Bochum /ID# 150873
  • Klinikum Darmstadt GmbH /ID# 150874
  • Staedtisches Klinikum Dessau /ID# 150876
  • University General Hospital Attikon /ID# 150841
  • Genl Hospital Andreas Syggros /ID# 150840
  • Genl Hospital Andreas Syggros /ID# 150842
  • St Vincent's University Hosp /ID# 150043
  • Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico /ID# 150069
  • A.O.U Sant'Anna di Ferrara /ID# 150066
  • Universita degli Studi di /ID# 150068
  • Policlinico Univ Tor Vergata /ID# 150142
  • Hospital Universitario Dr. Jose Eleuterio Gonzalez /ID# 151027
  • Radboud Universitair Medisch Centrum /ID# 152157
  • Universitair Medisch Centrum Groningen /ID# 150662
  • Erasmus Medisch Centrum /ID# 150672
  • Haukeland University Hospital /ID# 152662
  • Prywatny Osrodek Chirurgii Plastycznej Andrzej Bieniek /ID# 169413
  • Centro Hospitalar de Sao Joao, EPE /ID# 150885
  • Spitalul Universitar de Urgenta Elias /ID# 151072
  • Spitalul Municipal de Urgenta Timisoara /ID# 151073
  • City Clinical Hospital 15 /ID# 151281
  • NW State Med Univ NA Mechnikov /ID# 151197
  • King Faisal Specialist Hospital and Research Centre /ID# 153769
  • Corporac Sanitaria Parc Tauli /ID# 150789
  • Hospital Univ Germans Trias I Pujol /ID# 150787
  • Hospital Santa Creu i Sant Pau /ID# 152742
  • Hospital General Universitario Gregorio Maranon /ID# 150788
  • Hospital de Manises /ID# 150790
  • Karolinska Univ Sjukhuset /ID# 150817
  • Hacettepe University Medical Faculty /ID# 150829
  • Uludag University Medical Faculty /ID# 150831
  • Whipps Cross Univ Hospital /ID# 151699

Arms of the Study

Arm 1

Arm 2

Arm Type

Placebo Comparator

Active Comparator

Arm Label

Placebo

Adalimumab

Arm Description

Period A: Day 1- 4 subcutaneous (SC) injections; Week 2- 2 SC injections; Weeks 4-12- 1 SC injection each week Period B: Weeks 13-14- 1 SC injection each week Period C: Weeks 15-23- 1 SC injection each week

Period A: Day 1- 4 subcutaneous (SC) 40 mg injections; Week 2- 2 SC 40 mg injections; Weeks 4-12- 1 SC 40 mg injection each week Period B: Weeks 13-14- 1 SC 40 mg injection each week Period C: Weeks 15-23- 1 SC 40 mg injection each week

Outcomes

Primary Outcome Measures

Percentage of Participants Achieving Hidradenitis Suppurativa Clinical Response (HiSCR) at Week 12
HiSCR is defined as at least a 50% reduction in the abscess and inflammatory nodule (AN) count with no increase in abscess count and no increase in draining fistula count relative to Baseline.

Secondary Outcome Measures

Percentage of Participants Achieving HiSCR-es at Week 12
Hidradenitis Suppurativa Clinical Response-es (HiSCR-es) is defined as at least a 50% reduction in the abscess and inflammatory nodule (AN) count with no increase in abscess count and no increase in draining fistula count relative to Baseline, excluding the Hidradenitis Suppurativa surgical site.
Percentage of Participants Achieving HiSCR-es at Week 24
Hidradenitis Suppurativa Clinical Response-es (HiSCR-es) is defined as at least a 50% reduction in the abscess and inflammatory nodule (AN) count with no increase in abscess count and no increase in draining fistula count relative to Baseline, excluding the Hidradenitis Suppurativa surgical site.
Percent Change in the Surface Area of the Hidradenitis Suppurativa (HS) Surgical Site From Baseline to Week 12
The projected size of the surgical excision established by the designated surgeon during the Screening Period (calculated from a tracing of the outer perimeter onto an acetate sheet or equivalent) was recorded by the study physician. The change in the surface area of the projected HS surgical site from Baseline to Week 12 was documented.
Percentage of Participants at Week 12 That Require a Less Extensive Surgery Than the Surgical Plan (Determined at Baseline) or No Surgery
The projected size of the surgical excision established by the designated surgeon during the Screening Period (calculated from a tracing of the outer perimeter onto an acetate sheet or equivalent) was recorded by the study physician. The change in the surface area of the projected HS surgical site from Baseline to Week 12 was documented, and the percentage of participants at Week 12 requiring a less extensive surgery than the surgical plan (determined at Baseline) or no surgery as determined by the designated surgeon was recorded.

Full Information

First Posted
June 20, 2016
Last Updated
May 4, 2020
Sponsor
AbbVie
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1. Study Identification

Unique Protocol Identification Number
NCT02808975
Brief Title
Safety and Efficacy of Adalimumab (Humira) for Hidradenitis Suppurativa (HS) Peri-Surgically
Acronym
SHARPS
Official Title
A Phase 4, Double-blind, Randomized, Placebo-Controlled, Multicenter Study to Assess the Safety and Efficacy of Adalimumab Used in Conjunction With Surgery in Subjects With Moderate to Severe Hidradenitis Suppurativa
Study Type
Interventional

2. Study Status

Record Verification Date
May 2020
Overall Recruitment Status
Completed
Study Start Date
July 18, 2016 (Actual)
Primary Completion Date
May 16, 2019 (Actual)
Study Completion Date
October 16, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
AbbVie

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
The objective of this study was to assess the safety and efficacy of adalimumab prior to surgery in participants with moderate to severe Hidradenitis Suppurativa (HS) who were surgical candidates.
Detailed Description
This was an interventional, randomized, double-blind (DB), placebo-controlled study. The study duration included a 30-day Screening Period, an initial 12-week DB treatment pre-surgery period (Period A), a 2-week peri-operative period with continuation of weekly DB study drug administration (Period B), and a subsequent 10-week DB treatment post-operative period (Period C). Randomization (in a 1:1 ratio) in Period A was stratified by baseline Hurley Stage (II versus III) and anatomical location of the planned surgical site (i.e., axilla versus inguinal region). The projected size of the surgical excision established by the designated surgeon during the Screening Period (calculated from a tracing of the outer perimeter onto an acetate sheet or equivalent) was recorded. In Period B, the designated surgeon measured and recorded the surface area of the actual surgery, with surgery occurring during Week 13. Surgery and post-operative management (e.g., hospitalization, surgical wound care) was per local practice. No study drug was administered at Week 24, the final study visit. Participants were able to begin commercial product (as prescribed by the participants's physician) after all Week 24 procedures were completed.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hidradenitis Suppurativa (HS)
Keywords
Hidradenitis Suppurativa, Axilla, Inguinal region, Hurley Stage I, II, or III, Adalimumab, Secondary intention, Abcess and inflammatory nodule (AN) count

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
206 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Period A: Day 1- 4 subcutaneous (SC) injections; Week 2- 2 SC injections; Weeks 4-12- 1 SC injection each week Period B: Weeks 13-14- 1 SC injection each week Period C: Weeks 15-23- 1 SC injection each week
Arm Title
Adalimumab
Arm Type
Active Comparator
Arm Description
Period A: Day 1- 4 subcutaneous (SC) 40 mg injections; Week 2- 2 SC 40 mg injections; Weeks 4-12- 1 SC 40 mg injection each week Period B: Weeks 13-14- 1 SC 40 mg injection each week Period C: Weeks 15-23- 1 SC 40 mg injection each week
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Subcutaneous injections administered as described in arm description
Intervention Type
Drug
Intervention Name(s)
Adalimumab
Other Intervention Name(s)
Humira
Intervention Description
Subcutaneous injections administered as described in arm description
Primary Outcome Measure Information:
Title
Percentage of Participants Achieving Hidradenitis Suppurativa Clinical Response (HiSCR) at Week 12
Description
HiSCR is defined as at least a 50% reduction in the abscess and inflammatory nodule (AN) count with no increase in abscess count and no increase in draining fistula count relative to Baseline.
Time Frame
At Week 12
Secondary Outcome Measure Information:
Title
Percentage of Participants Achieving HiSCR-es at Week 12
Description
Hidradenitis Suppurativa Clinical Response-es (HiSCR-es) is defined as at least a 50% reduction in the abscess and inflammatory nodule (AN) count with no increase in abscess count and no increase in draining fistula count relative to Baseline, excluding the Hidradenitis Suppurativa surgical site.
Time Frame
At Week12
Title
Percentage of Participants Achieving HiSCR-es at Week 24
Description
Hidradenitis Suppurativa Clinical Response-es (HiSCR-es) is defined as at least a 50% reduction in the abscess and inflammatory nodule (AN) count with no increase in abscess count and no increase in draining fistula count relative to Baseline, excluding the Hidradenitis Suppurativa surgical site.
Time Frame
At Week 24
Title
Percent Change in the Surface Area of the Hidradenitis Suppurativa (HS) Surgical Site From Baseline to Week 12
Description
The projected size of the surgical excision established by the designated surgeon during the Screening Period (calculated from a tracing of the outer perimeter onto an acetate sheet or equivalent) was recorded by the study physician. The change in the surface area of the projected HS surgical site from Baseline to Week 12 was documented.
Time Frame
From Baseline to Week 12
Title
Percentage of Participants at Week 12 That Require a Less Extensive Surgery Than the Surgical Plan (Determined at Baseline) or No Surgery
Description
The projected size of the surgical excision established by the designated surgeon during the Screening Period (calculated from a tracing of the outer perimeter onto an acetate sheet or equivalent) was recorded by the study physician. The change in the surface area of the projected HS surgical site from Baseline to Week 12 was documented, and the percentage of participants at Week 12 requiring a less extensive surgery than the surgical plan (determined at Baseline) or no surgery as determined by the designated surgeon was recorded.
Time Frame
At Week 12

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Participant must have skin lesions that are diagnostic of Hidradenitis Suppurativa (HS) for at least 1 year (365 days) prior to the Baseline visit Participant must have at least 3 distinct anatomical regions involved with inflammatory (also termed 'active') HS lesions; plus either one axilla or one inguinal region (limited to the inguino-crural fold and adjacent areas) that requires excisional surgery, and with at least one of the other affected HS regions (e.g., contralateral inguinal region, buttocks, inframammary region) rated as Hurley Stage II or III Participant must have a total abscess and inflammatory nodule (AN) count of greater than or equal to 3 at the Baseline visit within the HS non-surgical sites The HS surgical site must contain at least one active HS lesion The HS surgical site must require excisional surgery and is large enough to require healing by secondary intention as assessed by the designated surgeon Exclusion Criteria: Participant has a draining fistula count of greater than 20 at the Baseline visit Participant requires surgery at any anatomical site other than an unilateral axilla or inguinal region site Participant requires surgical management prior to Week 13 Participant requires, based on the designated surgeon's assessment, excisional surgery with primary closure as the method of closure being most beneficial for the participant
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
AbbVie Inc.
Organizational Affiliation
AbbVie
Official's Role
Study Director
Facility Information:
Facility Name
Wallace Medical Group, Inc. /ID# 171289
City
Beverly Hills
State/Province
California
ZIP/Postal Code
90211
Country
United States
Facility Name
Encino Research Center / T. Jo /ID# 171347
City
Encino
State/Province
California
ZIP/Postal Code
91436
Country
United States
Facility Name
University of California Irvine /ID# 170054
City
Irvine
State/Province
California
ZIP/Postal Code
92697-1385
Country
United States
Facility Name
Tulane Univ /ID# 168441
City
New Orleans
State/Province
Louisiana
ZIP/Postal Code
70112
Country
United States
Facility Name
Beth Israel Deaconess Medical Center /ID# 168438
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02215-5400
Country
United States
Facility Name
University of Michigan Hospitals /ID# 200667
City
Ann Arbor
State/Province
Michigan
ZIP/Postal Code
48109
Country
United States
Facility Name
Univ NC Chapel Hill /ID# 168446
City
Chapel Hill
State/Province
North Carolina
ZIP/Postal Code
27514-4220
Country
United States
Facility Name
Penn State Hershey Medical Ctr /ID# 168447
City
Hershey
State/Province
Pennsylvania
ZIP/Postal Code
17033
Country
United States
Facility Name
Rhode Island Hospital /ID# 168439
City
Providence
State/Province
Rhode Island
ZIP/Postal Code
02903
Country
United States
Facility Name
CUB Hospital Erasme /ID# 150907
City
Brussels
State/Province
Bruxelles-Capitale
ZIP/Postal Code
1070
Country
Belgium
Facility Name
UZ Gent /ID# 150906
City
Gent
State/Province
Oost-Vlaanderen
ZIP/Postal Code
9000
Country
Belgium
Facility Name
NewLab Clinical Research Inc. /ID# 151315
City
St. John's
State/Province
Newfoundland and Labrador
ZIP/Postal Code
A1C 2H5
Country
Canada
Facility Name
York Dermatology Clinic and Research Centre /ID# 151314
City
Richmond Hill
State/Province
Ontario
ZIP/Postal Code
L4C 9M7
Country
Canada
Facility Name
Fundacion Valle Del Lili /ID# 151565
City
Cali
ZIP/Postal Code
760032
Country
Colombia
Facility Name
Hospital Pablo Tobon Uribe /ID# 152693
City
Medellín
Country
Colombia
Facility Name
Fakultni nemocnice Ostrava /ID# 169174
City
Ostrava
State/Province
Praha 5
ZIP/Postal Code
708 52
Country
Czechia
Facility Name
Fakult Nem Kralovske Vinohrady /ID# 169173
City
Prague
ZIP/Postal Code
100 34
Country
Czechia
Facility Name
Bispebjerg Hospital /ID# 150796
City
Copenhagen NV
State/Province
Hovedstaden
ZIP/Postal Code
2400
Country
Denmark
Facility Name
Sjaellands Universitets Hospit /ID# 150795
City
Roskilde
State/Province
Sjælland
ZIP/Postal Code
4000
Country
Denmark
Facility Name
Hopital Prive d'Antony /ID# 157347
City
Antony
State/Province
Ile-de-France
ZIP/Postal Code
92160
Country
France
Facility Name
Polyclinique Courlancy /ID# 157761
City
Reims
ZIP/Postal Code
51100
Country
France
Facility Name
Universitaetsklinikum Erlangen /ID# 167251
City
Erlangen
State/Province
Bayern
ZIP/Postal Code
91054
Country
Germany
Facility Name
Charité Universitätsmedizin Campus Mitte /ID# 150875
City
Berlin
ZIP/Postal Code
10117
Country
Germany
Facility Name
Klinikum Ruhr Univ Bochum /ID# 150873
City
Bochum
ZIP/Postal Code
44791
Country
Germany
Facility Name
Klinikum Darmstadt GmbH /ID# 150874
City
Darmstadt
ZIP/Postal Code
64297
Country
Germany
Facility Name
Staedtisches Klinikum Dessau /ID# 150876
City
Dessau
ZIP/Postal Code
06847
Country
Germany
Facility Name
University General Hospital Attikon /ID# 150841
City
Athens
State/Province
Attiki
ZIP/Postal Code
12462
Country
Greece
Facility Name
Genl Hospital Andreas Syggros /ID# 150840
City
Athens
ZIP/Postal Code
16121
Country
Greece
Facility Name
Genl Hospital Andreas Syggros /ID# 150842
City
Athens
ZIP/Postal Code
16121
Country
Greece
Facility Name
St Vincent's University Hosp /ID# 150043
City
Dublin
ZIP/Postal Code
D04 T6F4
Country
Ireland
Facility Name
Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico /ID# 150069
City
Milan
State/Province
Lombardia
ZIP/Postal Code
20122
Country
Italy
Facility Name
A.O.U Sant'Anna di Ferrara /ID# 150066
City
Ferrara
ZIP/Postal Code
44124
Country
Italy
Facility Name
Universita degli Studi di /ID# 150068
City
Modena
ZIP/Postal Code
41124
Country
Italy
Facility Name
Policlinico Univ Tor Vergata /ID# 150142
City
Rome
ZIP/Postal Code
00133
Country
Italy
Facility Name
Hospital Universitario Dr. Jose Eleuterio Gonzalez /ID# 151027
City
Monterrey
State/Province
Nuevo Leon
ZIP/Postal Code
64460
Country
Mexico
Facility Name
Radboud Universitair Medisch Centrum /ID# 152157
City
Nijmegen
State/Province
Gelderland
ZIP/Postal Code
6525 GA
Country
Netherlands
Facility Name
Universitair Medisch Centrum Groningen /ID# 150662
City
Groningen
ZIP/Postal Code
9713 GZ
Country
Netherlands
Facility Name
Erasmus Medisch Centrum /ID# 150672
City
Rotterdam
ZIP/Postal Code
3015 CE
Country
Netherlands
Facility Name
Haukeland University Hospital /ID# 152662
City
Bergen
State/Province
Hordaland
ZIP/Postal Code
5021
Country
Norway
Facility Name
Prywatny Osrodek Chirurgii Plastycznej Andrzej Bieniek /ID# 169413
City
Wrocław
State/Province
Dolnoslaskie
ZIP/Postal Code
52-016
Country
Poland
Facility Name
Centro Hospitalar de Sao Joao, EPE /ID# 150885
City
Porto
ZIP/Postal Code
4200-319
Country
Portugal
Facility Name
Spitalul Universitar de Urgenta Elias /ID# 151072
City
Bucharest
State/Province
Bucuresti
ZIP/Postal Code
011461
Country
Romania
Facility Name
Spitalul Municipal de Urgenta Timisoara /ID# 151073
City
Timişoara
State/Province
Timis
ZIP/Postal Code
300558
Country
Romania
Facility Name
City Clinical Hospital 15 /ID# 151281
City
Moscow
ZIP/Postal Code
111539
Country
Russian Federation
Facility Name
NW State Med Univ NA Mechnikov /ID# 151197
City
St. Petersburg
ZIP/Postal Code
193015
Country
Russian Federation
Facility Name
King Faisal Specialist Hospital and Research Centre /ID# 153769
City
Riyadh
State/Province
Najran
ZIP/Postal Code
11211
Country
Saudi Arabia
Facility Name
Corporac Sanitaria Parc Tauli /ID# 150789
City
Sabadell
State/Province
Barcelona
ZIP/Postal Code
08208
Country
Spain
Facility Name
Hospital Univ Germans Trias I Pujol /ID# 150787
City
Badalona
ZIP/Postal Code
08916
Country
Spain
Facility Name
Hospital Santa Creu i Sant Pau /ID# 152742
City
Barcelona
ZIP/Postal Code
08026
Country
Spain
Facility Name
Hospital General Universitario Gregorio Maranon /ID# 150788
City
Madrid
ZIP/Postal Code
28007
Country
Spain
Facility Name
Hospital de Manises /ID# 150790
City
Manises
ZIP/Postal Code
46940
Country
Spain
Facility Name
Karolinska Univ Sjukhuset /ID# 150817
City
Solna
ZIP/Postal Code
17176
Country
Sweden
Facility Name
Hacettepe University Medical Faculty /ID# 150829
City
Ankara
ZIP/Postal Code
06100
Country
Turkey
Facility Name
Uludag University Medical Faculty /ID# 150831
City
Bursa
ZIP/Postal Code
16059
Country
Turkey
Facility Name
Whipps Cross Univ Hospital /ID# 151699
City
London
State/Province
London, City Of
ZIP/Postal Code
E11 1NR
Country
United Kingdom

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Plan Description
AbbVie is committed to responsible data sharing regarding the clinical trials we sponsor. This includes access to anonymized, individual and trial-level data (analysis data sets), as well as other information (e.g., protocols and clinical study reports), as long as the trials are not part of an ongoing or planned regulatory submission. This includes requests for clinical trial data for unlicensed products and indications.
IPD Sharing Time Frame
Data requests can be submitted at any time and the data will be accessible for 12 months, with possible extensions considered.
IPD Sharing Access Criteria
Access to this clinical trial data can be requested by any qualified researchers who engage in rigorous, independent scientific research, and will be provided following review and approval of a research proposal and Statistical Analysis Plan (SAP) and execution of a Data Sharing Agreement (DSA). For more information on the process, or to submit a request, visit the following link.
IPD Sharing URL
https://www.abbvie.com/our-science/clinical-trials/clinical-trials-data-and-information-sharing/data-and-information-sharing-with-qualified-researchers.html
Citations:
PubMed Identifier
34406349
Citation
Bechara FG, Podda M, Prens EP, Horvath B, Giamarellos-Bourboulis EJ, Alavi A, Szepietowski JC, Kirby J, Geng Z, Jean C, Jemec GBE, Zouboulis CC. Efficacy and Safety of Adalimumab in Conjunction With Surgery in Moderate to Severe Hidradenitis Suppurativa: The SHARPS Randomized Clinical Trial. JAMA Surg. 2021 Nov 1;156(11):1001-1009. doi: 10.1001/jamasurg.2021.3655.
Results Reference
derived
Links:
URL
http://rxabbvie.com
Description
Related Info

Learn more about this trial

Safety and Efficacy of Adalimumab (Humira) for Hidradenitis Suppurativa (HS) Peri-Surgically

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