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

• Sponsor: AbbVie (Industry)
• Overall Status: Completed
• CT.gov ID: NCT02808975
• Collaborator: (none)
• Enrollment: 206
• Locations: 55
• Arms: 2
• Actual Duration (Months): 38.9
• Patients Per Site: 3.7
• Patients Per Site Per Month: 0.1

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Hidradenitis Suppurativa (HS)	Drug: Placebo; Drug: Adalimumab	Phase 4

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.

Study Design

• Study Type: Interventional
• Actual Enrollment: 206 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
• Primary Purpose: Treatment
• 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
• Actual Study Start Date: Jul 18, 2016
• Actual Primary Completion Date: May 16, 2019
• Actual Study Completion Date: Oct 16, 2019

Arms and Interventions

Arm	Intervention/Treatment
Placebo Comparator: Placebo 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	Drug: Placebo; Subcutaneous injections administered as described in arm description
Active Comparator: Adalimumab 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	Drug: Adalimumab; Subcutaneous injections administered as described in arm description; Other Names: Humira

Outcome Measures

Primary Outcome Measures

1. Percentage of Participants Achieving Hidradenitis Suppurativa Clinical Response (HiSCR) at Week 12 [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

1. Percentage of Participants Achieving HiSCR-es at Week 12 [At Week12]

   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.

2. Percentage of Participants Achieving HiSCR-es at Week 24 [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.

3. Percent Change in the Surface Area of the Hidradenitis Suppurativa (HS) Surgical Site From Baseline to Week 12 [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.

4. Percentage of Participants at Week 12 That Require a Less Extensive Surgery Than the Surgical Plan (Determined at Baseline) or No Surgery [At 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, 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.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 65 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Wallace Medical Group, Inc. /ID# 171289	Beverly Hills	California	United States	90211
2	Encino Research Center / T. Jo /ID# 171347	Encino	California	United States	91436
3	University of California Irvine /ID# 170054	Irvine	California	United States	92697-1385
4	Tulane Univ /ID# 168441	New Orleans	Louisiana	United States	70112
5	Beth Israel Deaconess Medical Center /ID# 168438	Boston	Massachusetts	United States	02215-5400
6	University of Michigan Hospitals /ID# 200667	Ann Arbor	Michigan	United States	48109
7	Univ NC Chapel Hill /ID# 168446	Chapel Hill	North Carolina	United States	27514-4220
8	Penn State Hershey Medical Ctr /ID# 168447	Hershey	Pennsylvania	United States	17033
9	Rhode Island Hospital /ID# 168439	Providence	Rhode Island	United States	02903
10	CUB Hospital Erasme /ID# 150907	Brussels	Bruxelles-Capitale	Belgium	1070
11	UZ Gent /ID# 150906	Gent	Oost-Vlaanderen	Belgium	9000
12	NewLab Clinical Research Inc. /ID# 151315	St. John's	Newfoundland and Labrador	Canada	A1C 2H5
13	York Dermatology Clinic and Research Centre /ID# 151314	Richmond Hill	Ontario	Canada	L4C 9M7
14	Fundacion Valle Del Lili /ID# 151565	Cali		Colombia	760032
15	Hospital Pablo Tobon Uribe /ID# 152693	Medellín		Colombia
16	Fakultni nemocnice Ostrava /ID# 169174	Ostrava	Praha 5	Czechia	708 52
17	Fakult Nem Kralovske Vinohrady /ID# 169173	Prague		Czechia	100 34
18	Bispebjerg Hospital /ID# 150796	Copenhagen NV	Hovedstaden	Denmark	2400
19	Sjaellands Universitets Hospit /ID# 150795	Roskilde	Sjælland	Denmark	4000
20	Hopital Prive d'Antony /ID# 157347	Antony	Ile-de-France	France	92160
21	Polyclinique Courlancy /ID# 157761	Reims		France	51100
22	Universitaetsklinikum Erlangen /ID# 167251	Erlangen	Bayern	Germany	91054
23	Charité Universitätsmedizin Campus Mitte /ID# 150875	Berlin		Germany	10117
24	Klinikum Ruhr Univ Bochum /ID# 150873	Bochum		Germany	44791
25	Klinikum Darmstadt GmbH /ID# 150874	Darmstadt		Germany	64297
26	Staedtisches Klinikum Dessau /ID# 150876	Dessau		Germany	06847
27	University General Hospital Attikon /ID# 150841	Athens	Attiki	Greece	12462
28	Genl Hospital Andreas Syggros /ID# 150840	Athens		Greece	16121
29	Genl Hospital Andreas Syggros /ID# 150842	Athens		Greece	16121
30	St Vincent's University Hosp /ID# 150043	Dublin		Ireland	D04 T6F4
31	Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico /ID# 150069	Milan	Lombardia	Italy	20122
32	A.O.U Sant'Anna di Ferrara /ID# 150066	Ferrara		Italy	44124
33	Universita degli Studi di /ID# 150068	Modena		Italy	41124
34	Policlinico Univ Tor Vergata /ID# 150142	Rome		Italy	00133
35	Hospital Universitario Dr. Jose Eleuterio Gonzalez /ID# 151027	Monterrey	Nuevo Leon	Mexico	64460
36	Radboud Universitair Medisch Centrum /ID# 152157	Nijmegen	Gelderland	Netherlands	6525 GA
37	Universitair Medisch Centrum Groningen /ID# 150662	Groningen		Netherlands	9713 GZ
38	Erasmus Medisch Centrum /ID# 150672	Rotterdam		Netherlands	3015 CE
39	Haukeland University Hospital /ID# 152662	Bergen	Hordaland	Norway	5021
40	Prywatny Osrodek Chirurgii Plastycznej Andrzej Bieniek /ID# 169413	Wrocław	Dolnoslaskie	Poland	52-016
41	Centro Hospitalar de Sao Joao, EPE /ID# 150885	Porto		Portugal	4200-319
42	Spitalul Universitar de Urgenta Elias /ID# 151072	Bucharest	Bucuresti	Romania	011461
43	Spitalul Municipal de Urgenta Timisoara /ID# 151073	Timişoara	Timis	Romania	300558
44	City Clinical Hospital 15 /ID# 151281	Moscow		Russian Federation	111539
45	NW State Med Univ NA Mechnikov /ID# 151197	St. Petersburg		Russian Federation	193015
46	King Faisal Specialist Hospital and Research Centre /ID# 153769	Riyadh	Najran	Saudi Arabia	11211
47	Corporac Sanitaria Parc Tauli /ID# 150789	Sabadell	Barcelona	Spain	08208
48	Hospital Univ Germans Trias I Pujol /ID# 150787	Badalona		Spain	08916
49	Hospital Santa Creu i Sant Pau /ID# 152742	Barcelona		Spain	08026
50	Hospital General Universitario Gregorio Maranon /ID# 150788	Madrid		Spain	28007
51	Hospital de Manises /ID# 150790	Manises		Spain	46940
52	Karolinska Univ Sjukhuset /ID# 150817	Solna		Sweden	17176
53	Hacettepe University Medical Faculty /ID# 150829	Ankara		Turkey	06100
54	Uludag University Medical Faculty /ID# 150831	Bursa		Turkey	16059
55	Whipps Cross Univ Hospital /ID# 151699	London	London, City Of	United Kingdom	E11 1NR

Sponsors and Collaborators

• AbbVie

Investigators

• Study Director: AbbVie Inc., AbbVie

Study Documents (Full-Text)

• Statistical Analysis Plan - Oct 2, 2019
• Study Protocol - Dec 14, 2017

More Information

Additional Information:

• Related Info

Publications

None provided.

• Responsible Party: AbbVie
• ClinicalTrials.gov Identifier: NCT02808975
• Other Study ID Numbers: M15-574; 2015-005161-23
• First Posted: Jun 22, 2016
• Last Update Posted: May 14, 2020
• Last Verified: May 1, 2020

• Individual Participant Data (IPD) Sharing Statement: Yes
• Plan to Share IPD: Yes
• 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
• Keywords provided by AbbVie: Hidradenitis Suppurativa; Axilla; Inguinal region; Hurley Stage I, II, or III; Adalimumab; Secondary intention; Abcess and inflammatory nodule (AN) count
• Additional relevant MeSH terms: Hidradenitis Suppurativa; Hidradenitis; Adalimumab

Study Results

Participant Flow

Pre-assignment Detail	Intent-to-Treat (ITT) population: all participants who were randomized at the Baseline visit

Arm/Group Title	Placebo	Adalimumab
Arm/Group 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
Period Title: Overall Study
STARTED	103	103
COMPLETED	81	84
NOT COMPLETED	22	19

Baseline Characteristics

Arm/Group Title	Placebo	Adalimumab	Total
Arm/Group 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	Total of all reporting groups
Overall Participants	103	103	206
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	36.8 (10.81)	38.5 (11.71)	37.6 (11.27)
Sex: Female, Male (Count of Participants)
Female	55 53.4%	51 49.5%	106 51.5%
Male	48 46.6%	52 50.5%	100 48.5%
Race/Ethnicity, Customized (Count of Participants)
White	97 94.2%	96 93.2%	193 93.7%
Black or African American	4 3.9%	4 3.9%	8 3.9%
Asian	1 1%	1 1%	2 1%
American Indian or Alaska Native	0 0%	2 1.9%	2 1%
Native Hawaiian or other Pacific Islander	0 0%	0 0%	0 0%
Multiple	0 0%	0 0%	0 0%
Missing	1 1%	0 0%	1 0.5%

Outcome Measures

1. Primary Outcome

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

Outcome Measure Data

Analysis Population Description

Intent-to-Treat (ITT) population: all participants who were randomized at the Baseline visit; non-responder imputation (NRI) was used for missing data

Arm/Group Title	Placebo	Adalimumab
Arm/Group 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
Measure Participants	103	103
Number (95% Confidence Interval) [percentage of participants]	34.0 33%	47.6 46.2%

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Placebo, Adalimumab
	Comments
	Type of Statistical Test	Superiority
	Comments
Statistical Test of Hypothesis	p-Value	=0.049
	Comments
	Method	Cochran-Mantel-Haenszel
	Comments	Across all strata, P-value calculated from Cochran-Mantel-Haenszel test adjusted for strata. Stratum containing zero count: 0.1 added to each cell.

2. Secondary Outcome

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

Outcome Measure Data

Analysis Population Description

Intent-to-Treat (ITT) population: all participants who were randomized at the Baseline visit; non-responder imputation (NRI) was used for missing data

Arm/Group Title	Placebo	Adalimumab
Arm/Group 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
Measure Participants	103	103
Number (95% Confidence Interval) [percentage of participants]	35.0 34%	47.6 46.2%

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Placebo, Adalimumab
	Comments
	Type of Statistical Test	Superiority
	Comments
Statistical Test of Hypothesis	p-Value	=0.067
	Comments
	Method	Cochran-Mantel-Haenszel
	Comments	Across all strata, P-value calculated from Cochran-Mantel-Haenszel test adjusted for strata. Stratum containing zero count: 0.1 added to each cell.

3. Secondary Outcome

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

Outcome Measure Data

Analysis Population Description

Intent-to-Treat (ITT) population: all participants who were randomized at the Baseline visit; non-responder imputation (NRI) was used for missing data

Arm/Group Title	Placebo	Adalimumab
Arm/Group 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
Measure Participants	103	103
Number (95% Confidence Interval) [percentage of participants]	31.1 30.2%	51.5 50%

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Placebo, Adalimumab
	Comments
	Type of Statistical Test	Superiority
	Comments
Statistical Test of Hypothesis	p-Value	=0.003
	Comments
	Method	Cochran-Mantel-Haenszel
	Comments	Across all strata, P-value calculated from Cochran-Mantel-Haenszel test adjusted for strata. Stratum containing zero count: 0.1 added to each cell.

4. Secondary Outcome

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

Outcome Measure Data

Analysis Population Description

Observed case (OC) analysis was performed on the intent-to-treat (ITT) population. The ITT population consisted of all participants who were randomized at the Baseline visit.

Arm/Group Title	Placebo	Adalimumab
Arm/Group 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
Measure Participants	79	76
Least Squares Mean (95% Confidence Interval) [percent change from Baseline]	26.233	68.190

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Placebo, Adalimumab
	Comments
	Type of Statistical Test	Superiority
	Comments
Statistical Test of Hypothesis	p-Value	=0.313
	Comments
	Method	ANCOVA
	Comments	Across all strata, P-values are calculated from ANCOVA with stratum, baseline value, and treatment in the model.

5. Secondary Outcome

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

Outcome Measure Data

Analysis Population Description

Observed case (OC) analysis was performed on the intent-to-treat (ITT) population. The ITT population consisted of all participants who were randomized at the Baseline visit.

Arm/Group Title	Placebo	Adalimumab
Arm/Group 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
Measure Participants	87	82
Number (95% Confidence Interval) [percentage of participants]	43.7 42.4%	46.3 45%

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Placebo, Adalimumab
	Comments
	Type of Statistical Test	Superiority
	Comments
Statistical Test of Hypothesis	p-Value	=0.746
	Comments
	Method	Cochran-Mantel-Haenszel
	Comments	Across all strata, P-value calculated from Cochran-Mantel-Haenszel test adjusted for strata. Stratum containing zero count: 0.1 added to each cell.

Adverse Events

Time Frame	Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from the first dose of study drug until 70 days after the last dose of study drug, up to 33 weeks.
Adverse Event Reporting Description	TEAEs and SAEs are defined as any adverse event (AE) with an onset date that is on or after the first dose of study drug until 70 days after the last dose of study drug and were collected whether elicited or spontaneously reported by the participant.
Arm/Group Title	Placebo		Adalimumab
Arm/Group 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
All Cause Mortality
	Placebo		Adalimumab
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/103 (0%)		2/103 (1.9%)
Serious Adverse Events
	Placebo		Adalimumab
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	3/103 (2.9%)		7/103 (6.8%)
Cardiac disorders
CARDIOVASCULAR DISORDER	1/103 (1%)	1	0/103 (0%)	0
Hepatobiliary disorders
CHOLELITHIASIS	0/103 (0%)	0	1/103 (1%)	1
Infections and infestations
BLASTOCYSTIS INFECTION	0/103 (0%)	0	1/103 (1%)	1
POSTOPERATIVE WOUND INFECTION	1/103 (1%)	1	0/103 (0%)	0
RESPIRATORY TRACT INFECTION	0/103 (0%)	0	1/103 (1%)	1
Musculoskeletal and connective tissue disorders
MUSCULOSKELETAL CHEST PAIN	0/103 (0%)	0	1/103 (1%)	1
PAIN IN EXTREMITY	0/103 (0%)	0	1/103 (1%)	1
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
TESTIS CANCER	0/103 (0%)	0	1/103 (1%)	1
Nervous system disorders
RUPTURED CEREBRAL ANEURYSM	0/103 (0%)	0	1/103 (1%)	1
Skin and subcutaneous tissue disorders
HIDRADENITIS	2/103 (1.9%)	2	0/103 (0%)	0
Other (Not Including Serious) Adverse Events
	Placebo		Adalimumab
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	43/103 (41.7%)		48/103 (46.6%)
Gastrointestinal disorders
DIARRHOEA	4/103 (3.9%)	4	6/103 (5.8%)	6
Infections and infestations
NASOPHARYNGITIS	19/103 (18.4%)	24	19/103 (18.4%)	23
Injury, poisoning and procedural complications
PROCEDURAL PAIN	8/103 (7.8%)	9	14/103 (13.6%)	14
Musculoskeletal and connective tissue disorders
ARTHRALGIA	1/103 (1%)	1	6/103 (5.8%)	6
Nervous system disorders
DIZZINESS	6/103 (5.8%)	7	2/103 (1.9%)	2
HEADACHE	14/103 (13.6%)	29	13/103 (12.6%)	13
Skin and subcutaneous tissue disorders
HIDRADENITIS	15/103 (14.6%)	19	14/103 (13.6%)	17

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

AbbVie requests that any investigator or institution that plans on presenting/publishing results disclosure, provide written notification of their request 60 days prior to their presentation/publication. AbbVie requests that no presentation/publication will be instituted until 12 months after a study is completed, or after the first presentation/publication whichever occurs first. A delay may be proposed of a presentation/publication if AbbVie needs to secure patent or proprietary protection.