Trial Outcomes & Findings for Study of Adalimumab in Subjects With Moderate to Severe Chronic Hidradenitis Suppurativa (NCT NCT00918255)

Last Updated: 2011-05-09

Results Overview

Clinical response is defined as a Physician's Global Assessment (PGA) of clear, minimal, or mild (scores of 0, 1, or 2) with a minimum of 2 grades improvement (reduction) from baseline. PGA is a physician's assessment of the severity of disease based on a 6-point scale (score of 0 = clear and 5 = very severe).

Recruitment status

COMPLETED

Study phase

PHASE2

Target enrollment

154 participants

Primary outcome timeframe

Baseline, Week 16

Results posted on

2011-05-09

Participant Flow

Participant milestones

Participant milestones
Measure	Adalimumab 40 mg Qwk DB Initial dose of adalimumab 160 mg at Week 0, adalimumab 80 mg at Week 2, followed by 40 mg weekly (qwk) starting at Week 4 through Week 15.	Adalimumab 40 mg Eow DB Initial dose of adalimumab 80 mg at Week 0, followed by adalimumab 40 mg eow (every other week) starting at Week 1 through Week 15.	Placebo DB Matching placebo for adalimumab, administered weekly starting at Week 0 through Week 15.
Overall Study STARTED	51	52	51
Overall Study COMPLETED	45	52	46
Overall Study NOT COMPLETED	6	0	5

Reasons for withdrawal

Reasons for withdrawal
Measure	Adalimumab 40 mg Qwk DB Initial dose of adalimumab 160 mg at Week 0, adalimumab 80 mg at Week 2, followed by 40 mg weekly (qwk) starting at Week 4 through Week 15.	Placebo DB Matching placebo for adalimumab, administered weekly starting at Week 0 through Week 15.
Overall Study Adverse Event	1	0
Overall Study Withdrawal by Subject	1	2
Overall Study Lack of Efficacy	1	0
Overall Study Lost to Follow-up	1	2
Overall Study Exceeded allowed number of interventions	0	1
Overall Study Non-compliance	1	0
Overall Study Investigator discretion	1	0

Baseline Characteristics

Study of Adalimumab in Subjects With Moderate to Severe Chronic Hidradenitis Suppurativa

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Adalimumab 40 mg Qwk DB n=51 Participants Loading dose of adalimumab 160 mg at Week 0, adalimumab 80 mg at Week 2, followed by 40 mg weekly (qwk) starting at Week 4 through Week 15.	Adalimumab 40 mg Eow DB n=52 Participants Loading dose of adalimumab 80 mg at Week 0, followed by adalimumab 40 mg eow (every other week) starting at Week 1 through Week 15.	Placebo DB n=51 Participants Matching placebo for adalimumab, administered weekly starting at Week 0 through Week 15.	Total n=154 Participants Total of all reporting groups
Age Continuous	35.1 years STANDARD_DEVIATION 10.69 • n=5 Participants	36.1 years STANDARD_DEVIATION 12.50 • n=7 Participants	37.8 years STANDARD_DEVIATION 12.10 • n=5 Participants	36.3 years STANDARD_DEVIATION 11.76 • n=4 Participants
Sex: Female, Male Female	36 Participants n=5 Participants	38 Participants n=7 Participants	36 Participants n=5 Participants	110 Participants n=4 Participants
Sex: Female, Male Male	15 Participants n=5 Participants	14 Participants n=7 Participants	15 Participants n=5 Participants	44 Participants n=4 Participants
Region of Enrollment United States	41 participants n=5 Participants	39 participants n=7 Participants	36 participants n=5 Participants	116 participants n=4 Participants
Region of Enrollment Europe	10 participants n=5 Participants	13 participants n=7 Participants	15 participants n=5 Participants	38 participants n=4 Participants

PRIMARY outcome

Timeframe: Baseline, Week 16

Population: Intent-to-treat analysis with non-responder imputation (participants with missing PGA scores counted as non-responders).

Outcome measures

Outcome measures
Measure	Adalimumab 40 mg Qwk DB n=51 Participants Initial dose of adalimumab 160 mg at Week 0, adalimumab 80 mg at Week 2, followed by 40 mg weekly (qwk) starting at Week 4 through Week 15.	Adalimumab 40 mg Eow DB n=52 Participants Initial dose of adalimumab 80 mg at Week 0, followed by adalimumab 40 mg eow (every other week) starting at Week 1 through Week 15.	Placebo DB n=51 Participants Matching placebo for adalimumab, administered weekly starting at Week 0 through Week 15.
Percentage of Participants Achieving Clinical Response at Week 16	17.6 percentage of participants	9.6 percentage of participants	3.9 percentage of participants

SECONDARY outcome

Timeframe: Baseline, Week 16

Population: Population was Intent-to-treat (ITT) and included participants with any inflammatory nodules (defined as tender, erythematous) or plaques at Baseline. Imputation method was Last Observation Carried Forward (LOCF).

Includes inflammatory nodules that are tender, erythematous, and have diameters less than 5 cm and includes plaques that have diameters greater than or equal to 5 cm. Range for percent change is negative infinity to infinity. Negative percent changes from Baseline indicate improvement.

Outcome measures

Outcome measures
Measure	Adalimumab 40 mg Qwk DB n=49 Participants Initial dose of adalimumab 160 mg at Week 0, adalimumab 80 mg at Week 2, followed by 40 mg weekly (qwk) starting at Week 4 through Week 15.	Adalimumab 40 mg Eow DB n=48 Participants Initial dose of adalimumab 80 mg at Week 0, followed by adalimumab 40 mg eow (every other week) starting at Week 1 through Week 15.	Placebo DB n=48 Participants Matching placebo for adalimumab, administered weekly starting at Week 0 through Week 15.
Percent Change From Baseline in Number of All Inflammatory Nodules and Plaques at Week 16	-50.66 percent change Standard Error 11.364	-30.43 percent change Standard Error 11.452	-13.66 percent change Standard Error 11.452

SECONDARY outcome

Timeframe: Baseline, Week 2

Population: Intent-to-treat analysis with non-responder imputation (participants with missing PGA scores counted as non-responders).

Outcome measures

Outcome measures
Measure	Adalimumab 40 mg Qwk DB n=51 Participants Initial dose of adalimumab 160 mg at Week 0, adalimumab 80 mg at Week 2, followed by 40 mg weekly (qwk) starting at Week 4 through Week 15.	Adalimumab 40 mg Eow DB n=52 Participants Initial dose of adalimumab 80 mg at Week 0, followed by adalimumab 40 mg eow (every other week) starting at Week 1 through Week 15.	Placebo DB n=51 Participants Matching placebo for adalimumab, administered weekly starting at Week 0 through Week 15.
Percentage of Participants Achieving Clinical Response at Week 2	2.0 percentage of participants	9.6 percentage of participants	2.0 percentage of participants

SECONDARY outcome

Timeframe: Baseline, Week 4

Population: Intent-to-treat analysis with non-responder imputation (participants with missing PGA scores counted as non-responders).

Outcome measures

Outcome measures
Measure	Adalimumab 40 mg Qwk DB n=51 Participants Initial dose of adalimumab 160 mg at Week 0, adalimumab 80 mg at Week 2, followed by 40 mg weekly (qwk) starting at Week 4 through Week 15.	Adalimumab 40 mg Eow DB n=52 Participants Initial dose of adalimumab 80 mg at Week 0, followed by adalimumab 40 mg eow (every other week) starting at Week 1 through Week 15.	Placebo DB n=51 Participants Matching placebo for adalimumab, administered weekly starting at Week 0 through Week 15.
Percentage of Participants Achieving Clinical Response at Week 4	11.8 percentage of participants	5.8 percentage of participants	2.0 percentage of participants

SECONDARY outcome

Timeframe: Baseline, Week 8

Population: Intent-to-treat analysis with non-responder imputation (participants with missing PGA scores counted as non-responders).

Outcome measures

Outcome measures
Measure	Adalimumab 40 mg Qwk DB n=51 Participants Initial dose of adalimumab 160 mg at Week 0, adalimumab 80 mg at Week 2, followed by 40 mg weekly (qwk) starting at Week 4 through Week 15.	Adalimumab 40 mg Eow DB n=52 Participants Initial dose of adalimumab 80 mg at Week 0, followed by adalimumab 40 mg eow (every other week) starting at Week 1 through Week 15.	Placebo DB n=51 Participants Matching placebo for adalimumab, administered weekly starting at Week 0 through Week 15.
Percentage of Participants Achieving Clinical Response at Week 8	7.8 percentage of participants	5.8 percentage of participants	7.8 percentage of participants

SECONDARY outcome

Timeframe: Baseline, Week 12

Population: Intent-to-treat analysis with non-responder imputation (participants with missing PGA scores counted as non-responders).

Outcome measures

Outcome measures
Measure	Adalimumab 40 mg Qwk DB n=51 Participants Initial dose of adalimumab 160 mg at Week 0, adalimumab 80 mg at Week 2, followed by 40 mg weekly (qwk) starting at Week 4 through Week 15.	Adalimumab 40 mg Eow DB n=52 Participants Initial dose of adalimumab 80 mg at Week 0, followed by adalimumab 40 mg eow (every other week) starting at Week 1 through Week 15.	Placebo DB n=51 Participants Matching placebo for adalimumab, administered weekly starting at Week 0 through Week 15.
Percentage of Participants Achieving Clinical Response at Week 12	21.6 percentage of participants	7.7 percentage of participants	5.9 percentage of participants

SECONDARY outcome

Timeframe: Baseline, Week 16

Population: Population was Intent-to-treat (ITT). Imputation method was Last Observation Carried Forward (LOCF).

The Modified Sartorius Scale reflects changes in hidradenitis suppurative symptoms, namely the number of lesions (abscesses, nodules, and fistulas) and the longest distance between lesions. A total score is derived based on assessments at up to 8 distinct anatomical regions and ranges from 5 to indefinite. Smaller numbers are better scores and indicate less lesion involvement, thus decreases (negative changes) from baseline indicate improvement in severity of disease.

Outcome measures

Outcome measures
Measure	Adalimumab 40 mg Qwk DB n=51 Participants Initial dose of adalimumab 160 mg at Week 0, adalimumab 80 mg at Week 2, followed by 40 mg weekly (qwk) starting at Week 4 through Week 15.	Adalimumab 40 mg Eow DB n=52 Participants Initial dose of adalimumab 80 mg at Week 0, followed by adalimumab 40 mg eow (every other week) starting at Week 1 through Week 15.	Placebo DB n=51 Participants Matching placebo for adalimumab, administered weekly starting at Week 0 through Week 15.
Change From Baseline in Modified Sartorius Scale at Week 16	-30.0 scores on a scale Inter-Quartile Range 53.82 • Interval -50.0 to -7.0	-16.0 scores on a scale Inter-Quartile Range 82.54 • Interval -47.0 to 0.0	-7.5 scores on a scale Inter-Quartile Range 47.78 • Interval -30.0 to 10.0

SECONDARY outcome

Timeframe: Baseline, Week 52

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Baseline, Week 52

Outcome measures

Outcome data not reported

Adverse Events

Adalimumab 40 mg Qwk DB

Serious events: 4 serious events

Other events: 36 other events

Deaths: 0 deaths

Adalimumab 40 mg Eow DB

Serious events: 3 serious events

Other events: 33 other events

Deaths: 0 deaths

Placebo DB

Serious events: 2 serious events

Other events: 30 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Adalimumab 40 mg Qwk DB n=51 participants at risk Loading dose of adalimumab 160 mg at Week 0, adalimumab 80 mg at Week 2, followed by 40 mg weekly (qwk) starting at Week 4 through Week 15.	Adalimumab 40 mg Eow DB n=52 participants at risk Loading dose of adalimumab 80 mg at Week 0, followed by adalimumab 40 mg eow (every other week) starting at Week 1 through Week 15.	Placebo DB n=51 participants at risk Matching placebo for adalimumab, administered weekly starting at Week 0 through Week 15.
Blood and lymphatic system disorders Anaemia	2.0% 1/51 • For the 3 treatment groups in Period 1 (Adalimumab 40 mg Qwk, Adalimumab 40 mg Eow, and Placebo): Week 0 up to Week 16. For Open-label adalimumab (Period 2): Week 16 through Week 52 plus 70 days after the last dose. Assessment and recording of adverse events and serious adverse events was performed by the investigator at each study visit. Information on events that occurred 70-days after the last dose of study drug (Week 52 or early termination) was collected during a follow-up phone call.	0.00% 0/52 • For the 3 treatment groups in Period 1 (Adalimumab 40 mg Qwk, Adalimumab 40 mg Eow, and Placebo): Week 0 up to Week 16. For Open-label adalimumab (Period 2): Week 16 through Week 52 plus 70 days after the last dose. Assessment and recording of adverse events and serious adverse events was performed by the investigator at each study visit. Information on events that occurred 70-days after the last dose of study drug (Week 52 or early termination) was collected during a follow-up phone call.	0.00% 0/51 • For the 3 treatment groups in Period 1 (Adalimumab 40 mg Qwk, Adalimumab 40 mg Eow, and Placebo): Week 0 up to Week 16. For Open-label adalimumab (Period 2): Week 16 through Week 52 plus 70 days after the last dose. Assessment and recording of adverse events and serious adverse events was performed by the investigator at each study visit. Information on events that occurred 70-days after the last dose of study drug (Week 52 or early termination) was collected during a follow-up phone call.
Gastrointestinal disorders Small intestinal obstruction	0.00% 0/51 • For the 3 treatment groups in Period 1 (Adalimumab 40 mg Qwk, Adalimumab 40 mg Eow, and Placebo): Week 0 up to Week 16. For Open-label adalimumab (Period 2): Week 16 through Week 52 plus 70 days after the last dose. Assessment and recording of adverse events and serious adverse events was performed by the investigator at each study visit. Information on events that occurred 70-days after the last dose of study drug (Week 52 or early termination) was collected during a follow-up phone call.	0.00% 0/52 • For the 3 treatment groups in Period 1 (Adalimumab 40 mg Qwk, Adalimumab 40 mg Eow, and Placebo): Week 0 up to Week 16. For Open-label adalimumab (Period 2): Week 16 through Week 52 plus 70 days after the last dose. Assessment and recording of adverse events and serious adverse events was performed by the investigator at each study visit. Information on events that occurred 70-days after the last dose of study drug (Week 52 or early termination) was collected during a follow-up phone call.	2.0% 1/51 • For the 3 treatment groups in Period 1 (Adalimumab 40 mg Qwk, Adalimumab 40 mg Eow, and Placebo): Week 0 up to Week 16. For Open-label adalimumab (Period 2): Week 16 through Week 52 plus 70 days after the last dose. Assessment and recording of adverse events and serious adverse events was performed by the investigator at each study visit. Information on events that occurred 70-days after the last dose of study drug (Week 52 or early termination) was collected during a follow-up phone call.
General disorders Non-cardiac chest pain	2.0% 1/51 • For the 3 treatment groups in Period 1 (Adalimumab 40 mg Qwk, Adalimumab 40 mg Eow, and Placebo): Week 0 up to Week 16. For Open-label adalimumab (Period 2): Week 16 through Week 52 plus 70 days after the last dose. Assessment and recording of adverse events and serious adverse events was performed by the investigator at each study visit. Information on events that occurred 70-days after the last dose of study drug (Week 52 or early termination) was collected during a follow-up phone call.	0.00% 0/52 • For the 3 treatment groups in Period 1 (Adalimumab 40 mg Qwk, Adalimumab 40 mg Eow, and Placebo): Week 0 up to Week 16. For Open-label adalimumab (Period 2): Week 16 through Week 52 plus 70 days after the last dose. Assessment and recording of adverse events and serious adverse events was performed by the investigator at each study visit. Information on events that occurred 70-days after the last dose of study drug (Week 52 or early termination) was collected during a follow-up phone call.	0.00% 0/51 • For the 3 treatment groups in Period 1 (Adalimumab 40 mg Qwk, Adalimumab 40 mg Eow, and Placebo): Week 0 up to Week 16. For Open-label adalimumab (Period 2): Week 16 through Week 52 plus 70 days after the last dose. Assessment and recording of adverse events and serious adverse events was performed by the investigator at each study visit. Information on events that occurred 70-days after the last dose of study drug (Week 52 or early termination) was collected during a follow-up phone call.
Infections and infestations Escherichia infection	2.0% 1/51 • For the 3 treatment groups in Period 1 (Adalimumab 40 mg Qwk, Adalimumab 40 mg Eow, and Placebo): Week 0 up to Week 16. For Open-label adalimumab (Period 2): Week 16 through Week 52 plus 70 days after the last dose. Assessment and recording of adverse events and serious adverse events was performed by the investigator at each study visit. Information on events that occurred 70-days after the last dose of study drug (Week 52 or early termination) was collected during a follow-up phone call.	0.00% 0/52 • For the 3 treatment groups in Period 1 (Adalimumab 40 mg Qwk, Adalimumab 40 mg Eow, and Placebo): Week 0 up to Week 16. For Open-label adalimumab (Period 2): Week 16 through Week 52 plus 70 days after the last dose. Assessment and recording of adverse events and serious adverse events was performed by the investigator at each study visit. Information on events that occurred 70-days after the last dose of study drug (Week 52 or early termination) was collected during a follow-up phone call.	0.00% 0/51 • For the 3 treatment groups in Period 1 (Adalimumab 40 mg Qwk, Adalimumab 40 mg Eow, and Placebo): Week 0 up to Week 16. For Open-label adalimumab (Period 2): Week 16 through Week 52 plus 70 days after the last dose. Assessment and recording of adverse events and serious adverse events was performed by the investigator at each study visit. Information on events that occurred 70-days after the last dose of study drug (Week 52 or early termination) was collected during a follow-up phone call.
Infections and infestations Genital infection bacterial	2.0% 1/51 • For the 3 treatment groups in Period 1 (Adalimumab 40 mg Qwk, Adalimumab 40 mg Eow, and Placebo): Week 0 up to Week 16. For Open-label adalimumab (Period 2): Week 16 through Week 52 plus 70 days after the last dose. Assessment and recording of adverse events and serious adverse events was performed by the investigator at each study visit. Information on events that occurred 70-days after the last dose of study drug (Week 52 or early termination) was collected during a follow-up phone call.	0.00% 0/52 • For the 3 treatment groups in Period 1 (Adalimumab 40 mg Qwk, Adalimumab 40 mg Eow, and Placebo): Week 0 up to Week 16. For Open-label adalimumab (Period 2): Week 16 through Week 52 plus 70 days after the last dose. Assessment and recording of adverse events and serious adverse events was performed by the investigator at each study visit. Information on events that occurred 70-days after the last dose of study drug (Week 52 or early termination) was collected during a follow-up phone call.	0.00% 0/51 • For the 3 treatment groups in Period 1 (Adalimumab 40 mg Qwk, Adalimumab 40 mg Eow, and Placebo): Week 0 up to Week 16. For Open-label adalimumab (Period 2): Week 16 through Week 52 plus 70 days after the last dose. Assessment and recording of adverse events and serious adverse events was performed by the investigator at each study visit. Information on events that occurred 70-days after the last dose of study drug (Week 52 or early termination) was collected during a follow-up phone call.
Infections and infestations Pilonidal cyst	0.00% 0/51 • For the 3 treatment groups in Period 1 (Adalimumab 40 mg Qwk, Adalimumab 40 mg Eow, and Placebo): Week 0 up to Week 16. For Open-label adalimumab (Period 2): Week 16 through Week 52 plus 70 days after the last dose. Assessment and recording of adverse events and serious adverse events was performed by the investigator at each study visit. Information on events that occurred 70-days after the last dose of study drug (Week 52 or early termination) was collected during a follow-up phone call.	1.9% 1/52 • For the 3 treatment groups in Period 1 (Adalimumab 40 mg Qwk, Adalimumab 40 mg Eow, and Placebo): Week 0 up to Week 16. For Open-label adalimumab (Period 2): Week 16 through Week 52 plus 70 days after the last dose. Assessment and recording of adverse events and serious adverse events was performed by the investigator at each study visit. Information on events that occurred 70-days after the last dose of study drug (Week 52 or early termination) was collected during a follow-up phone call.	0.00% 0/51 • For the 3 treatment groups in Period 1 (Adalimumab 40 mg Qwk, Adalimumab 40 mg Eow, and Placebo): Week 0 up to Week 16. For Open-label adalimumab (Period 2): Week 16 through Week 52 plus 70 days after the last dose. Assessment and recording of adverse events and serious adverse events was performed by the investigator at each study visit. Information on events that occurred 70-days after the last dose of study drug (Week 52 or early termination) was collected during a follow-up phone call.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Vocal cord neoplasm	2.0% 1/51 • For the 3 treatment groups in Period 1 (Adalimumab 40 mg Qwk, Adalimumab 40 mg Eow, and Placebo): Week 0 up to Week 16. For Open-label adalimumab (Period 2): Week 16 through Week 52 plus 70 days after the last dose. Assessment and recording of adverse events and serious adverse events was performed by the investigator at each study visit. Information on events that occurred 70-days after the last dose of study drug (Week 52 or early termination) was collected during a follow-up phone call.	0.00% 0/52 • For the 3 treatment groups in Period 1 (Adalimumab 40 mg Qwk, Adalimumab 40 mg Eow, and Placebo): Week 0 up to Week 16. For Open-label adalimumab (Period 2): Week 16 through Week 52 plus 70 days after the last dose. Assessment and recording of adverse events and serious adverse events was performed by the investigator at each study visit. Information on events that occurred 70-days after the last dose of study drug (Week 52 or early termination) was collected during a follow-up phone call.	0.00% 0/51 • For the 3 treatment groups in Period 1 (Adalimumab 40 mg Qwk, Adalimumab 40 mg Eow, and Placebo): Week 0 up to Week 16. For Open-label adalimumab (Period 2): Week 16 through Week 52 plus 70 days after the last dose. Assessment and recording of adverse events and serious adverse events was performed by the investigator at each study visit. Information on events that occurred 70-days after the last dose of study drug (Week 52 or early termination) was collected during a follow-up phone call.
Psychiatric disorders Suicide attempt	0.00% 0/51 • For the 3 treatment groups in Period 1 (Adalimumab 40 mg Qwk, Adalimumab 40 mg Eow, and Placebo): Week 0 up to Week 16. For Open-label adalimumab (Period 2): Week 16 through Week 52 plus 70 days after the last dose. Assessment and recording of adverse events and serious adverse events was performed by the investigator at each study visit. Information on events that occurred 70-days after the last dose of study drug (Week 52 or early termination) was collected during a follow-up phone call.	0.00% 0/52 • For the 3 treatment groups in Period 1 (Adalimumab 40 mg Qwk, Adalimumab 40 mg Eow, and Placebo): Week 0 up to Week 16. For Open-label adalimumab (Period 2): Week 16 through Week 52 plus 70 days after the last dose. Assessment and recording of adverse events and serious adverse events was performed by the investigator at each study visit. Information on events that occurred 70-days after the last dose of study drug (Week 52 or early termination) was collected during a follow-up phone call.	2.0% 1/51 • For the 3 treatment groups in Period 1 (Adalimumab 40 mg Qwk, Adalimumab 40 mg Eow, and Placebo): Week 0 up to Week 16. For Open-label adalimumab (Period 2): Week 16 through Week 52 plus 70 days after the last dose. Assessment and recording of adverse events and serious adverse events was performed by the investigator at each study visit. Information on events that occurred 70-days after the last dose of study drug (Week 52 or early termination) was collected during a follow-up phone call.
Respiratory, thoracic and mediastinal disorders Interstitial lung disease	0.00% 0/51 • For the 3 treatment groups in Period 1 (Adalimumab 40 mg Qwk, Adalimumab 40 mg Eow, and Placebo): Week 0 up to Week 16. For Open-label adalimumab (Period 2): Week 16 through Week 52 plus 70 days after the last dose. Assessment and recording of adverse events and serious adverse events was performed by the investigator at each study visit. Information on events that occurred 70-days after the last dose of study drug (Week 52 or early termination) was collected during a follow-up phone call.	1.9% 1/52 • For the 3 treatment groups in Period 1 (Adalimumab 40 mg Qwk, Adalimumab 40 mg Eow, and Placebo): Week 0 up to Week 16. For Open-label adalimumab (Period 2): Week 16 through Week 52 plus 70 days after the last dose. Assessment and recording of adverse events and serious adverse events was performed by the investigator at each study visit. Information on events that occurred 70-days after the last dose of study drug (Week 52 or early termination) was collected during a follow-up phone call.	0.00% 0/51 • For the 3 treatment groups in Period 1 (Adalimumab 40 mg Qwk, Adalimumab 40 mg Eow, and Placebo): Week 0 up to Week 16. For Open-label adalimumab (Period 2): Week 16 through Week 52 plus 70 days after the last dose. Assessment and recording of adverse events and serious adverse events was performed by the investigator at each study visit. Information on events that occurred 70-days after the last dose of study drug (Week 52 or early termination) was collected during a follow-up phone call.
Skin and subcutaneous tissue disorders Hidradenitis	0.00% 0/51 • For the 3 treatment groups in Period 1 (Adalimumab 40 mg Qwk, Adalimumab 40 mg Eow, and Placebo): Week 0 up to Week 16. For Open-label adalimumab (Period 2): Week 16 through Week 52 plus 70 days after the last dose. Assessment and recording of adverse events and serious adverse events was performed by the investigator at each study visit. Information on events that occurred 70-days after the last dose of study drug (Week 52 or early termination) was collected during a follow-up phone call.	1.9% 1/52 • For the 3 treatment groups in Period 1 (Adalimumab 40 mg Qwk, Adalimumab 40 mg Eow, and Placebo): Week 0 up to Week 16. For Open-label adalimumab (Period 2): Week 16 through Week 52 plus 70 days after the last dose. Assessment and recording of adverse events and serious adverse events was performed by the investigator at each study visit. Information on events that occurred 70-days after the last dose of study drug (Week 52 or early termination) was collected during a follow-up phone call.	0.00% 0/51 • For the 3 treatment groups in Period 1 (Adalimumab 40 mg Qwk, Adalimumab 40 mg Eow, and Placebo): Week 0 up to Week 16. For Open-label adalimumab (Period 2): Week 16 through Week 52 plus 70 days after the last dose. Assessment and recording of adverse events and serious adverse events was performed by the investigator at each study visit. Information on events that occurred 70-days after the last dose of study drug (Week 52 or early termination) was collected during a follow-up phone call.

Other adverse events

Additional Information

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