Not provided
Not provided
| ID | Type | Description | Link |
|---|---|---|---|
| 2011-003400-20 | EudraCT Number |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
A study to evaluate the safety and efficacy of treatment with adalimumab in adults with moderate to severe hidradenitis suppurativa (HS).
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 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.
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Placebo | Placebo Comparator | Placebo for 12 weeks. |
|
| Adalimumab Every Week (EW) | Experimental | Adalimumab ew for 12 weeks (160 mg at Week 0; 80 mg at Week 2; and 40 mg ew from Week 4 to Week 12). |
|
| Placebo/Adalimumab Every Week (EW) | Experimental | Participants randomized to receive placebo in Period 1 received adalimumab 160 mg at Week 12, 80 mg at Week 14, and 40 mg ew from Week 16 to Week 35 in Period 2 (up to 24 weeks). |
|
| Adalimumab Every Week (EW)/Placebo | Experimental | Participants randomized to receive adalimumab ew in Period 1 were re-randomized to receive placebo ew from Week 12 to Week 35 in Period 2 (up to 24 weeks). |
|
| Adalimumab Every Week (EW)/ Adalimumab Every Other Week (EOW) | Experimental | Participants randomized to receive adalimumab ew in Period 1 were re-randomized to receive adalimumab 40 mg eow from Week 12 to Week 35 in Period 2; placebo injections were administered eow from Week 13 to Week 35 (up to 24 weeks). |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| adalimumab | Biological | Adalimumab pre-filled syringe, administered by subcutaneous injection |
|
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Participants Achieving Hidradenitis Suppurativa Clinical Response (HiSCR) at Week 12 | HiSCR was defined as at least a 50% reduction in abscess and inflammatory nodule (AN) count with no increase in abscess count and no increase in draining fistula count at Week 12 relative to Baseline. Data are presented for all participants and by baseline Hurley Stage (Stage 1: Abscess formation, single or multiple, without sinus tracts and scarring; Stage II: One or more widely separated recurrent abscesses with tract formation and scars. A participant with at least 1 anatomic region with Hurley Stage II disease and with no anatomic regions with Hurley Stage III disease was classified as Hurley Stage II; and Stage III: Multiple interconnected tracts and abscesses across the entire area, with diffuse or near diffuse involvement. A participant with at least 1 anatomic region with Hurley Stage III disease was classified as Hurley Stage III). Non-responder imputation (NRI): Participants with missing data were considered non-responders. | Baseline (Week 0) up to Week 12 |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Participants With Baseline Hurley Stage II Who Achieved Abscess and Inflammatory Nodule (AN) Count of 0, 1, or 2 at Week 12 | The percentage of participants with AN counts lowered to 0, 1, or 2 at Week 12 among participants with Hurley Stage II at Baseline. NRI: Participants with missing data were considered non-responders. | Baseline (Week 0) up to Week 12 |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Subject was previously treated with adalimumab or another anti-tumor necrosis factor (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:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| David Williams, MD | AbbVie | Study Chair |
Not provided
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 27518661 | Result | Kimball AB, Okun MM, Williams DA, Gottlieb AB, Papp KA, Zouboulis CC, Armstrong AW, Kerdel F, Gold MH, Forman SB, Korman NJ, Giamarellos-Bourboulis EJ, Crowley JJ, Lynde C, Reguiai Z, Prens EP, Alwawi E, Mostafa NM, Pinsky B, Sundaram M, Gu Y, Carlson DM, Jemec GB. Two Phase 3 Trials of Adalimumab for Hidradenitis Suppurativa. N Engl J Med. 2016 Aug 4;375(5):422-34. doi: 10.1056/NEJMoa1504370. | |
| 39141589 |
| Label | URL |
|---|---|
| Related Info | View source |
Not provided
Not provided
Participants ≥ 18 years of age with HS for at least 1 year prior to Baseline and HS lesions present in at least 2 distinct anatomical areas (one of which must be at least Hurley Stage II or III) who had experienced inadequate response to ≥ 90 day treatment of oral antibiotics for HS were eligible for enrolment in the study.
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | Placebo | Placebo for 12 weeks. |
| FG001 | Adalimumab Every Week (EW) | Adalimumab ew for 12 weeks (160 mg at Week 0; 80 mg at Week 2; and 40 mg ew from Week 4 to Week 12). |
| FG002 | Placebo/Adalimumab Every Week (EW) | Participants randomized to receive placebo in Period 1 received adalimumab 160 mg at Week 12, 80 mg at Week 14, and 40 mg ew from Week 16 to Week 35 in Period 2 (up to 24 weeks). |
| FG003 | Adalimumab Every Week (EW)/Placebo | Participants randomized to receive adalimumab ew in Period 1 were re-randomized to receive placebo ew from Week 12 to Week 35 in Period 2 (up to 24 weeks). |
| FG004 | Adalimumab Every Week (EW)/ Adalimumab Every Other Week (EOW) | Participants randomized to receive adalimumab ew in Period 1 were re-randomized to receive adalimumab 40 mg eow from Week 12 to Week 35 in Period 2; placebo injections were administered eow from Week 13 to Week 35 (up to 24 weeks). |
| FG005 | Adalimumab Every Week (EW)/Adalimumab Every Week (EW) | Participants randomized to receive adalimumab ew in Period 1 were re-randomized to receive 40 mg adalimumab ew from Week 12 to Week 35 in Period 2 (up to 24 weeks). |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Treatment Period 1 |
|
| |||||||||||||||||||||
| Treatment Period 2 |
|
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Placebo | Placebo for 12 weeks. |
| BG001 | Adalimumab Every Week (EW) | Adalimumab ew for 12 weeks (160 mg at Week 0; 80 mg at Week 2; and 40 mg ew from Week 4 to Week 12). |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Percentage of Participants Achieving Hidradenitis Suppurativa Clinical Response (HiSCR) at Week 12 | HiSCR was defined as at least a 50% reduction in abscess and inflammatory nodule (AN) count with no increase in abscess count and no increase in draining fistula count at Week 12 relative to Baseline. Data are presented for all participants and by baseline Hurley Stage (Stage 1: Abscess formation, single or multiple, without sinus tracts and scarring; Stage II: One or more widely separated recurrent abscesses with tract formation and scars. A participant with at least 1 anatomic region with Hurley Stage II disease and with no anatomic regions with Hurley Stage III disease was classified as Hurley Stage II; and Stage III: Multiple interconnected tracts and abscesses across the entire area, with diffuse or near diffuse involvement. A participant with at least 1 anatomic region with Hurley Stage III disease was classified as Hurley Stage III). Non-responder imputation (NRI): Participants with missing data were considered non-responders. | The intention-to-treat (ITT) population, defined as all participants who were randomized at Baseline (Week 0), was analyzed overall and by baseline Hurley Stage | Posted | Number | percentage of participants | Baseline (Week 0) up to Week 12 |
Adverse Events were collected from first dose of study drug until 70 days following last dose of study drug (46 weeks); Serious Adverse Events were collected from the time that informed consent was obtained (up to 50 weeks).
Adverse Events with onset in Period 1 were collected from first dose of study drug until prior to the first dose in Period 2, or up to 70 days following last dose of study drug if the participant discontinued during Period 1.
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Placebo (Period 1) | Placebo for 12 weeks |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| ABDOMINAL PAIN | Gastrointestinal disorders | MedDRA 16.1 | Systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| ANAEMIA | Blood and lymphatic system disorders | MedDRA 16.1 | Systematic Assessment |
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Global Medical Information | AbbVie | 1-800-633-9110 |
| ID | Term |
|---|---|
| D017497 | Hidradenitis Suppurativa |
| D000152 | Acne Vulgaris |
| D011565 | Psoriasis |
| D005667 | Furunculosis |
| ID | Term |
|---|---|
| D017192 | Skin Diseases, Bacterial |
| D001424 | Bacterial Infections |
| D001423 | Bacterial Infections and Mycoses |
| D007239 | Infections |
Not provided
Not provided
| ID | Term |
|---|---|
| D000068879 | Adalimumab |
| ID | Term |
|---|---|
| D061067 | Antibodies, Monoclonal, Humanized |
| D000911 | Antibodies, Monoclonal |
| D000906 | Antibodies |
| D007136 | Immunoglobulins |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
|
| Adalimumab Every Week (EW)/Adalimumab Every Week (EW) | Experimental | Participants randomized to receive adalimumab ew in Period 1 were re-randomized to receive 40 mg adalimumab ew from Week 12 to Week 35 in Period 2 (up to 24 weeks). |
|
|
| placebo | Biological | Placebo pre-filled syringe, administered by subcutaneous injection |
|
| Percentage of Participants Achieving At Least 30% Reduction and At Least 1 Unit Reduction From Baseline in Patient's Global Assessment of Skin Pain (NRS30) - At Worst at Week 12 Among Participants With Baseline Skin Pain NRS ≥ 3 | The Patient's Global Assessment of Skin Pain Numeric Rating Scale (NRS) was used to assess the worst skin pain and the average skin pain due to HS. Ratings for the 2 items range from 0 (no skin pain) to 10 (skin pain as bad as you can imagine). The assessments were completed on a daily diary by participants before they went to bed and responded to the items based on a recall period of the "last 24 hours." The percentage of participants who achieved at least 30% reduction and at least 1 unit reduction from Baseline in the Patient's Global Assessment of Skin Pain (NRS30) - at worst at Week 12 among participants with Baseline NRS ≥ 3 are presented. Weekly averages of daily assessments were analyzed. NRI: Participants with missing data were considered non-responders. | Baseline (Week 0) up to Week 12 |
| Change From Baseline to Week 12 in Modified Sartorius Score | The Sartorius Scale is used to quantify the severity of HS. Points are awarded for 12 body areas (left and right axillae, left and right sub/inframammary areas, intermammary area, left and right buttocks, left and right inguino-crural folds, perianal area, perineal area, and other): points were awarded for nodules (2 points for each); abscesses (4 points); fistulas (4 points); scars (1 point); other findings (1 point); and longest distance between two lesions (2-6 points, 0 if no lesions); and if lesions are separated by normal skin (yes-0 points; No-6 points). The total Sartorius score is the sum of the 12 regional scores. Last Observation Carried Forward (LOCF): The last completed evaluation from the previous visit within the particular period for efficacy measures was carried forward to impute missing data at later visits in the same period. Baseline efficacy evaluations were not carried forward. | Baseline (Week 0) and Week 12 |
| Derived |
| Kearney N, Chen X, Bi Y, Hew K, Smith KM, Kirby B. Treatment of hidradenitis suppurativa with adalimumab in the PIONEER I and II randomized controlled trials reduced indices of systemic inflammation, recognized risk factors for cardiovascular disease. Clin Exp Dermatol. 2025 Jan 27;50(2):339-347. doi: 10.1093/ced/llae324. |
| 29380251 | Derived | Ryan C, Sobell JM, Leonardi CL, Lynde CW, Karunaratne M, Valdecantos WC, Hendrickson BA. Safety of Adalimumab Dosed Every Week and Every Other Week: Focus on Patients with Hidradenitis Suppurativa or Psoriasis. Am J Clin Dermatol. 2018 Jun;19(3):437-447. doi: 10.1007/s40257-017-0341-6. |
| Protocol Violation |
|
| Withdrawal by Subject |
|
| Lost to Follow-up |
|
| Other |
|
| COMPLETED |
|
| NOT COMPLETED |
|
|
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| ID | Title | Description |
|---|---|---|
| OG000 | Placebo | Placebo for 12 weeks. |
| OG001 | Adalimumab Every Week (EW) | Adalimumab ew for 12 weeks (160 mg at Week 0; 80 mg at Week 2; and 40 mg ew from Week 4 to Week 12). |
| OG002 | Placebo - Baseline Hurley Stage II | Participants with baseline Hurley Stage II randomized to receive placebo every week (ew) for 12 weeks. |
| OG003 | Placebo - Baseline Hurley Stage III | Participants with baseline Hurley Stage III randomized to receive placebo every week (ew) for 12 weeks. |
| OG004 | Adalimumab Every Week (EW) - Baseline Hurley Stage II | Participants with baseline Hurley Stage II randomized to receive adalimumab ew 160 mg at Week 12, 80 mg at Week 14, and 40 mg ew from Week 16 to 35 (up to 24 weeks). |
| OG005 | Adalimumab Every Week (ew) - Baseline Hurley Stage III | Participants with baseline Hurley Stage III randomized to receive adalimumab ew 160 mg at Week 12, 80 mg at Week 14, and 40 mg ew from Week 16 to 35 (up to 24 weeks). |
|
|
|
| Secondary | Percentage of Participants With Baseline Hurley Stage II Who Achieved Abscess and Inflammatory Nodule (AN) Count of 0, 1, or 2 at Week 12 | The percentage of participants with AN counts lowered to 0, 1, or 2 at Week 12 among participants with Hurley Stage II at Baseline. NRI: Participants with missing data were considered non-responders. | Participants in the ITT population with baseline Hurley Stage II | Posted | Number | percentage of participants | Baseline (Week 0) up to Week 12 |
|
|
|
|
| Secondary | Percentage of Participants Achieving At Least 30% Reduction and At Least 1 Unit Reduction From Baseline in Patient's Global Assessment of Skin Pain (NRS30) - At Worst at Week 12 Among Participants With Baseline Skin Pain NRS ≥ 3 | The Patient's Global Assessment of Skin Pain Numeric Rating Scale (NRS) was used to assess the worst skin pain and the average skin pain due to HS. Ratings for the 2 items range from 0 (no skin pain) to 10 (skin pain as bad as you can imagine). The assessments were completed on a daily diary by participants before they went to bed and responded to the items based on a recall period of the "last 24 hours." The percentage of participants who achieved at least 30% reduction and at least 1 unit reduction from Baseline in the Patient's Global Assessment of Skin Pain (NRS30) - at worst at Week 12 among participants with Baseline NRS ≥ 3 are presented. Weekly averages of daily assessments were analyzed. NRI: Participants with missing data were considered non-responders. | Participants in the ITT population with baseline NRS at Worst ≥ 3 | Posted | Number | percentage of participants | Baseline (Week 0) up to Week 12 |
|
|
|
|
| Secondary | Change From Baseline to Week 12 in Modified Sartorius Score | The Sartorius Scale is used to quantify the severity of HS. Points are awarded for 12 body areas (left and right axillae, left and right sub/inframammary areas, intermammary area, left and right buttocks, left and right inguino-crural folds, perianal area, perineal area, and other): points were awarded for nodules (2 points for each); abscesses (4 points); fistulas (4 points); scars (1 point); other findings (1 point); and longest distance between two lesions (2-6 points, 0 if no lesions); and if lesions are separated by normal skin (yes-0 points; No-6 points). The total Sartorius score is the sum of the 12 regional scores. Last Observation Carried Forward (LOCF): The last completed evaluation from the previous visit within the particular period for efficacy measures was carried forward to impute missing data at later visits in the same period. Baseline efficacy evaluations were not carried forward. | Participants in the ITT population | Posted | Least Squares Mean | Standard Error | units on a scale | Baseline (Week 0) and Week 12 |
|
|
|
|
| 5 |
| 152 |
| 81 |
| 152 |
| EG001 | Adalimumab EW (Period 1) | Adalimumab every week (ew) for 12 weeks (160 mg at Week 0; 80 mg at Week 2; and 40 mg ew from Week 4 to Week 12). | 3 | 153 | 64 | 153 |
| EG002 | Placebo/Adalimumab EW (Period 2) | Participants randomized to receive placebo in Period 1 were re-randomized to receive adalimumab 160 mg at Week 12, 80 mg at Week 14, and 40 mg every week (ew) from Week 16 to Week 35 in Period 2 (up to 24 weeks). | 5 | 145 | 68 | 145 |
| EG003 | Adalimumab EW/Placebo (Period 2) | Participants randomized to receive adalimumab every week (ew) in Period 1 were re-randomized to receive placebo ew from Week 12 to Week 35 in Period 2 (up to 24 weeks). | 2 | 49 | 30 | 49 |
| EG004 | Adalimumab EW/Adalimumab EOW (Period 2) | Participants randomized to receive adalimumab every week (ew) in Period 1 were re-randomized to receive adalimumab 40 mg every other week (eow) from Week 12 to Week 35 in Period 2; placebo injections were administered eow from Week 13 to Week 35 (up to 24 weeks). | 3 | 48 | 24 | 48 |
| EG005 | Adalimumab EW/Adalimumab EW (Period 2) | Participants randomized to receive adalimumab every week (ew) in Period 1 were re-randomized to receive 40 mg adalimumab ew from Week 12 to Week 35 in Period 2 (up to 24 weeks). | 1 | 48 | 28 | 48 |
| EFFUSION | General disorders | MedDRA 16.1 | Systematic Assessment |
|
| PNEUMONIA | Infections and infestations | MedDRA 16.1 | Systematic Assessment |
|
| PYELONEPHRITIS | Infections and infestations | MedDRA 16.1 | Systematic Assessment |
|
| HEPATITIS A ANTIBODY POSITIVE | Investigations | MedDRA 16.1 | Systematic Assessment |
|
| LIVER FUNCTION TEST ABNORMAL | Investigations | MedDRA 16.1 | Systematic Assessment |
|
| INTERVERTEBRAL DISC CALCIFICATION | Musculoskeletal and connective tissue disorders | MedDRA 16.1 | Systematic Assessment |
|
| TENDONITIS | Musculoskeletal and connective tissue disorders | MedDRA 16.1 | Systematic Assessment |
|
| INVASIVE DUCTAL BREAST CARCINOMA | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 16.1 | Systematic Assessment |
|
| ECTOPIC PREGNANCY | Pregnancy, puerperium and perinatal conditions | MedDRA 16.1 | Systematic Assessment |
|
| CHRONIC OBSTRUCTIVE PULMONARY DISEASE | Respiratory, thoracic and mediastinal disorders | MedDRA 16.1 | Systematic Assessment |
|
| HIDRADENITIS | Skin and subcutaneous tissue disorders | MedDRA 16.1 | Systematic Assessment |
|
| ABORTION INDUCED | Surgical and medical procedures | MedDRA 16.1 | Systematic Assessment |
|
| LEUKOCYTOSIS | Blood and lymphatic system disorders | MedDRA 16.1 | Systematic Assessment |
|
| NEUTROPHILIA | Blood and lymphatic system disorders | MedDRA 16.1 | Systematic Assessment |
|
| VERTIGO | Ear and labyrinth disorders | MedDRA 16.1 | Systematic Assessment |
|
| HYPOTHYROIDISM | Endocrine disorders | MedDRA 16.1 | Systematic Assessment |
|
| BLEPHARITIS | Eye disorders | MedDRA 16.1 | Systematic Assessment |
|
| EYELID OEDEMA | Eye disorders | MedDRA 16.1 | Systematic Assessment |
|
| MEIBOMIAN GLAND DYSFUNCTION | Eye disorders | MedDRA 16.1 | Systematic Assessment |
|
| VISUAL IMPAIRMENT | Eye disorders | MedDRA 16.1 | Systematic Assessment |
|
| ABDOMINAL PAIN UPPER | Gastrointestinal disorders | MedDRA 16.1 | Systematic Assessment |
|
| CONSTIPATION | Gastrointestinal disorders | MedDRA 16.1 | Systematic Assessment |
|
| DIARRHOEA | Gastrointestinal disorders | MedDRA 16.1 | Systematic Assessment |
|
| DRY MOUTH | Gastrointestinal disorders | MedDRA 16.1 | Systematic Assessment |
|
| GASTRITIS | Gastrointestinal disorders | MedDRA 16.1 | Systematic Assessment |
|
| LIP SWELLING | Gastrointestinal disorders | MedDRA 16.1 | Systematic Assessment |
|
| NAUSEA | Gastrointestinal disorders | MedDRA 16.1 | Systematic Assessment |
|
| TOOTHACHE | Gastrointestinal disorders | MedDRA 16.1 | Systematic Assessment |
|
| VOMITING | Gastrointestinal disorders | MedDRA 16.1 | Systematic Assessment |
|
| CHILLS | General disorders | MedDRA 16.1 | Systematic Assessment |
|
| FATIGUE | General disorders | MedDRA 16.1 | Systematic Assessment |
|
| INJECTION SITE BRUISING | General disorders | MedDRA 16.1 | Systematic Assessment |
|
| INJECTION SITE ERYTHEMA | General disorders | MedDRA 16.1 | Systematic Assessment |
|
| INJECTION SITE PRURITUS | General disorders | MedDRA 16.1 | Systematic Assessment |
|
| LOCAL SWELLING | General disorders | MedDRA 16.1 | Systematic Assessment |
|
| NON-CARDIAC CHEST PAIN | General disorders | MedDRA 16.1 | Systematic Assessment |
|
| PYREXIA | General disorders | MedDRA 16.1 | Systematic Assessment |
|
| XEROSIS | General disorders | MedDRA 16.1 | Systematic Assessment |
|
| CHOLELITHIASIS | Hepatobiliary disorders | MedDRA 16.1 | Systematic Assessment |
|
| HYPERSENSITIVITY | Immune system disorders | MedDRA 16.1 | Systematic Assessment |
|
| BODY TINEA | Infections and infestations | MedDRA 16.1 | Systematic Assessment |
|
| BRONCHITIS | Infections and infestations | MedDRA 16.1 | Systematic Assessment |
|
| CELLULITIS | Infections and infestations | MedDRA 16.1 | Systematic Assessment |
|
| CYTOLYTIC VAGINOSIS | Infections and infestations | MedDRA 16.1 | Systematic Assessment |
|
| EAR INFECTION | Infections and infestations | MedDRA 16.1 | Systematic Assessment |
|
| FOLLICULITIS | Infections and infestations | MedDRA 16.1 | Systematic Assessment |
|
| IMPETIGO | Infections and infestations | MedDRA 16.1 | Systematic Assessment |
|
| INFLUENZA | Infections and infestations | MedDRA 16.1 | Systematic Assessment |
|
| LOWER RESPIRATORY TRACT INFECTION | Infections and infestations | MedDRA 16.1 | Systematic Assessment |
|
| MEASLES | Infections and infestations | MedDRA 16.1 | Systematic Assessment |
|
| NASOPHARYNGITIS | Infections and infestations | MedDRA 16.1 | Systematic Assessment |
|
| ORAL HERPES | Infections and infestations | MedDRA 16.1 | Systematic Assessment |
|
| OTITIS MEDIA | Infections and infestations | MedDRA 16.1 | Systematic Assessment |
|
| PHARYNGITIS | Infections and infestations | MedDRA 16.1 | Systematic Assessment |
|
| PHARYNGITIS STREPTOCOCCAL | Infections and infestations | MedDRA 16.1 | Systematic Assessment |
|
| PNEUMONIA | Infections and infestations | MedDRA 16.1 | Systematic Assessment |
|
| POSTOPERATIVE WOUND INFECTION | Infections and infestations | MedDRA 16.1 | Systematic Assessment |
|
| RASH PUSTULAR | Infections and infestations | MedDRA 16.1 | Systematic Assessment |
|
| RHINITIS | Infections and infestations | MedDRA 16.1 | Systematic Assessment |
|
| SINUSITIS | Infections and infestations | MedDRA 16.1 | Systematic Assessment |
|
| SKIN CANDIDA | Infections and infestations | MedDRA 16.1 | Systematic Assessment |
|
| TINEA INFECTION | Infections and infestations | MedDRA 16.1 | Systematic Assessment |
|
| TONSILLITIS | Infections and infestations | MedDRA 16.1 | Systematic Assessment |
|
| TRACHEITIS | Infections and infestations | MedDRA 16.1 | Systematic Assessment |
|
| UPPER RESPIRATORY TRACT INFECTION | Infections and infestations | MedDRA 16.1 | Systematic Assessment |
|
| URINARY TRACT INFECTION | Infections and infestations | MedDRA 16.1 | Systematic Assessment |
|
| CONTUSION | Injury, poisoning and procedural complications | MedDRA 16.1 | Systematic Assessment |
|
| EXCORIATION | Injury, poisoning and procedural complications | MedDRA 16.1 | Systematic Assessment |
|
| FALL | Injury, poisoning and procedural complications | MedDRA 16.1 | Systematic Assessment |
|
| LIGAMENT SPRAIN | Injury, poisoning and procedural complications | MedDRA 16.1 | Systematic Assessment |
|
| ROAD TRAFFIC ACCIDENT | Injury, poisoning and procedural complications | MedDRA 16.1 | Systematic Assessment |
|
| SKIN INJURY | Injury, poisoning and procedural complications | MedDRA 16.1 | Systematic Assessment |
|
| ALANINE AMINOTRANSFERASE INCREASED | Investigations | MedDRA 16.1 | Systematic Assessment |
|
| ASPARTATE AMINOTRANSFERASE INCREASED | Investigations | MedDRA 16.1 | Systematic Assessment |
|
| BLOOD ALKALINE PHOSPHATASE INCREASED | Investigations | MedDRA 16.1 | Systematic Assessment |
|
| BLOOD GLUCOSE INCREASED | Investigations | MedDRA 16.1 | Systematic Assessment |
|
| BLOOD TRIGLYCERIDES INCREASED | Investigations | MedDRA 16.1 | Systematic Assessment |
|
| C-REACTIVE PROTEIN INCREASED | Investigations | MedDRA 16.1 | Systematic Assessment |
|
| WEIGHT DECREASED | Investigations | MedDRA 16.1 | Systematic Assessment |
|
| WEIGHT INCREASED | Investigations | MedDRA 16.1 | Systematic Assessment |
|
| WHITE BLOOD CELL COUNT DECREASED | Investigations | MedDRA 16.1 | Systematic Assessment |
|
| DIABETES MELLITUS | Metabolism and nutrition disorders | MedDRA 16.1 | Systematic Assessment |
|
| HYPERGLYCAEMIA | Metabolism and nutrition disorders | MedDRA 16.1 | Systematic Assessment |
|
| HYPERLIPIDAEMIA | Metabolism and nutrition disorders | MedDRA 16.1 | Systematic Assessment |
|
| HYPOKALAEMIA | Metabolism and nutrition disorders | MedDRA 16.1 | Systematic Assessment |
|
| TYPE 2 DIABETES MELLITUS | Metabolism and nutrition disorders | MedDRA 16.1 | Systematic Assessment |
|
| VITAMIN D DEFICIENCY | Metabolism and nutrition disorders | MedDRA 16.1 | Systematic Assessment |
|
| ARTHRALGIA | Musculoskeletal and connective tissue disorders | MedDRA 16.1 | Systematic Assessment |
|
| BACK PAIN | Musculoskeletal and connective tissue disorders | MedDRA 16.1 | Systematic Assessment |
|
| INTERVERTEBRAL DISC DEGENERATION | Musculoskeletal and connective tissue disorders | MedDRA 16.1 | Systematic Assessment |
|
| JOINT SWELLING | Musculoskeletal and connective tissue disorders | MedDRA 16.1 | Systematic Assessment |
|
| MUSCULOSKELETAL STIFFNESS | Musculoskeletal and connective tissue disorders | MedDRA 16.1 | Systematic Assessment |
|
| MYALGIA | Musculoskeletal and connective tissue disorders | MedDRA 16.1 | Systematic Assessment |
|
| DIZZINESS | Nervous system disorders | MedDRA 16.1 | Systematic Assessment |
|
| HEADACHE | Nervous system disorders | MedDRA 16.1 | Systematic Assessment |
|
| LETHARGY | Nervous system disorders | MedDRA 16.1 | Systematic Assessment |
|
| NERVE COMPRESSION | Nervous system disorders | MedDRA 16.1 | Systematic Assessment |
|
| PARAESTHESIA | Nervous system disorders | MedDRA 16.1 | Systematic Assessment |
|
| SINUS HEADACHE | Nervous system disorders | MedDRA 16.1 | Systematic Assessment |
|
| SYNCOPE | Nervous system disorders | MedDRA 16.1 | Systematic Assessment |
|
| DEPRESSION | Psychiatric disorders | MedDRA 16.1 | Systematic Assessment |
|
| INSOMNIA | Psychiatric disorders | MedDRA 16.1 | Systematic Assessment |
|
| DYSURIA | Renal and urinary disorders | MedDRA 16.1 | Systematic Assessment |
|
| HAEMATURIA | Renal and urinary disorders | MedDRA 16.1 | Systematic Assessment |
|
| VAGINAL HAEMORRHAGE | Reproductive system and breast disorders | MedDRA 16.1 | Systematic Assessment |
|
| ASTHMA | Respiratory, thoracic and mediastinal disorders | MedDRA 16.1 | Systematic Assessment |
|
| COUGH | Respiratory, thoracic and mediastinal disorders | MedDRA 16.1 | Systematic Assessment |
|
| OROPHARYNGEAL PAIN | Respiratory, thoracic and mediastinal disorders | MedDRA 16.1 | Systematic Assessment |
|
| RESPIRATORY TRACT CONGESTION | Respiratory, thoracic and mediastinal disorders | MedDRA 16.1 | Systematic Assessment |
|
| SINUS CONGESTION | Respiratory, thoracic and mediastinal disorders | MedDRA 16.1 | Systematic Assessment |
|
| SNEEZING | Respiratory, thoracic and mediastinal disorders | MedDRA 16.1 | Systematic Assessment |
|
| ACNE CYSTIC | Skin and subcutaneous tissue disorders | MedDRA 16.1 | Systematic Assessment |
|
| ALOPECIA | Skin and subcutaneous tissue disorders | MedDRA 16.1 | Systematic Assessment |
|
| DERMAL CYST | Skin and subcutaneous tissue disorders | MedDRA 16.1 | Systematic Assessment |
|
| DERMATITIS CONTACT | Skin and subcutaneous tissue disorders | MedDRA 16.1 | Systematic Assessment |
|
| DERMATITIS PAPILLARIS CAPILLITII | Skin and subcutaneous tissue disorders | MedDRA 16.1 | Systematic Assessment |
|
| DERMATITIS PSORIASIFORM | Skin and subcutaneous tissue disorders | MedDRA 16.1 | Systematic Assessment |
|
| ECZEMA | Skin and subcutaneous tissue disorders | MedDRA 16.1 | Systematic Assessment |
|
| ECZEMA ASTEATOTIC | Skin and subcutaneous tissue disorders | MedDRA 16.1 | Systematic Assessment |
|
| HIDRADENITIS | Skin and subcutaneous tissue disorders | MedDRA 16.1 | Systematic Assessment |
|
| INTERTRIGO | Skin and subcutaneous tissue disorders | MedDRA 16.1 | Systematic Assessment |
|
| KELOID SCAR | Skin and subcutaneous tissue disorders | MedDRA 16.1 | Systematic Assessment |
|
| HYPERTENSION | Vascular disorders | MedDRA 16.1 | Systematic Assessment |
|
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.
| D012874 | Skin Diseases, Infectious |
| D013492 | Suppuration |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D016575 | Hidradenitis |
| D013543 | Sweat Gland Diseases |
| D017486 | Acneiform Eruptions |
| D012625 | Sebaceous Gland Diseases |
| D017444 | Skin Diseases, Papulosquamous |
| D013207 | Staphylococcal Skin Infections |
| D013203 | Staphylococcal Infections |
| D016908 | Gram-Positive Bacterial Infections |
| D005393 | Fish Diseases |
| D000820 | Animal Diseases |
| D007162 |
| Immunoproteins |
| D001798 | Blood Proteins |
| D011506 | Proteins |
| D000602 | Amino Acids, Peptides, and Proteins |
| D012712 | Serum Globulins |
| D005916 | Globulins |