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| ID | Type | Description | Link |
|---|---|---|---|
| 2011-003478-98 | EudraCT Number |
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The purpose of this study to evaluate the long term safety, tolerability and efficacy of adalimumab in subjects with moderate to severe hidradenitis suppurativa (HS).
HS is a painful, chronic skin disease characterized by recurrent inflamed nodules and abscesses, which may rupture to form fistulas and subsequent scarring. This study is an open-label extension study available to subjects who participated in a prior adalimumab study who meet all the inclusion and none of the exclusion criteria.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Adalimumab Every Week | Experimental | Adalimumab 40 mg every week. |
|
| 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 in the EW/EW/EW, EW/EOW/EW, and EW/PBO/EW Analysis Populations Achieving Clinical Response Per Hidradenitis Suppurativa Clinical Response (HiSCR) at Each Visit | Clinical response per HiSCR defined as percent reduction from baseline of the prior phase 3 study in the abscess and inflammatory nodule ≥ 50% (AN50) with no increase in the abscess count and no increase in the draining fistula count. Last Observation Carried Forward (LOCF): The last completed evaluation from the previous visit was carried forward to impute missing data at later visits. | Weeks 2 (first dose of adalimumab in prior phase 3 study), 4, 8, 12, 16, 20, 24, 36, 48, 60, 72, 84, 96, 108, 120, 132, 144, 156, 168, 180, 192, 204, and 216 |
| Percentage of Participants in the PBO/EW/EW Analysis Population Achieving Clinical Response Per HiSCR at Each Visit | Clinical response per HiSCR defined as percent reduction from baseline of the prior phase 3 study in the abscess and inflammatory nodule ≥ 50% (AN50) with no increase in the abscess count and no increase in the draining fistula count. LOCF: The last completed evaluation from the previous visit was carried forward to impute missing data at later visits. | Entry of Period B in prior phase 3 study, Weeks 12, 24, 36, 48, 60, 72, 84, 96, 108, 120, 132, 144, 156, 168, 180, 192, and 204 |
| Percentage of Participants in the PBO/PBO/EW Analysis Population Achieving Clinical Response Per HiSCR at Each Visit | Clinical response per HiSCR defined as percent reduction from baseline of the prior phase 3 study in the abscess and inflammatory nodule ≥ 50% (AN50) with no increase in the abscess count and no increase in the draining fistula count. LOCF: The last completed evaluation from the previous visit was carried forward to impute missing data at later visits. | Entry of M12-555, Weeks 4, 8, 12, 18, 24, 36, 48, 60, 72, 84, 96, 108, 120, 132, 144, 156, 168, 180, and 192 |
| Percentage of Participants in the EW/EW/EW Analysis Population Who Achieved Abscess and Inflammatory Nodule (AN) Count of 0, 1, or 2 at Each Visit |
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Inclusion Criteria:
Subjects who previously participated in a prior Phase 3 AbbVie hidradenitis suppurativa (HS) study (M11-313 or M11-810) and:
Completed the study; or
Experienced a loss of response (LOR); or
Experienced worsening or absence of improvement
Exclusion Criteria:
Prior treatment with any other anti-tumour necrosis factor (anti-TNF) therapy (e.g., infliximab, etanercept), or participation in an adalimumab trial other than a prior Phase 3 AbbVie HS study.
Subject received any oral antibiotic treatment for HS within 28 days prior to the Baseline visit, except for antibiotics permitted in a prior Phase 3 AbbVie HS study.
Subject received prescription topical therapies for the treatment of HS within 14 days prior to the Baseline visit of Study M12-555.
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| Name | Affiliation | Role |
|---|---|---|
| AbbVie Inc. | AbbVie | Study Director |
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| Label | URL |
|---|---|
| Related Info. | View source |
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Subjects were evaluated for entry into Study M12-555 at the final study visit of the prior phase 3 study in which they participated. Therefore, the Study M12-555 Week 0 visit and administration of the first dose of study drug in Study M12-555 was performed on the same day as the final or last visit of the prior Phase 3 study.
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| ID | Title | Description |
|---|---|---|
| FG000 | Adalimumab Every Week | Adalimumab 40 mg every week. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
Baseline characteristics provided by reporting groups defined by treatment received in the prior phase 3 studies, plus adalimumab every week (EW) received in M12-555. Baseline defined as the last measurement prior to the first dose of study drug in the prior phase 3 study (M11-810 or M11-310 for baseline characteristics.
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| ID | Title | Description |
|---|---|---|
| BG000 | EW/EW/EW | All participants who received adalimumab 40 mg every week (EW) in both Period A and Period B of the prior Phase 3 studies. |
| BG001 | EW/EOW/EW | All participants who received adalimumab 40 mg every week (EW) in Period A and 40 mg every other week (EOW) in Period B in the prior Phase 3 studies. |
| 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 in the EW/EW/EW, EW/EOW/EW, and EW/PBO/EW Analysis Populations Achieving Clinical Response Per Hidradenitis Suppurativa Clinical Response (HiSCR) at Each Visit | Clinical response per HiSCR defined as percent reduction from baseline of the prior phase 3 study in the abscess and inflammatory nodule ≥ 50% (AN50) with no increase in the abscess count and no increase in the draining fistula count. Last Observation Carried Forward (LOCF): The last completed evaluation from the previous visit was carried forward to impute missing data at later visits. | All participants with evaluable data at given time point. | Posted | Number | percentage of participants | Weeks 2 (first dose of adalimumab in prior phase 3 study), 4, 8, 12, 16, 20, 24, 36, 48, 60, 72, 84, 96, 108, 120, 132, 144, 156, 168, 180, 192, 204, and 216 |
|
Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from first dose of study drug until 70 days after the last dose of study drug (up to 225 weeks).
TEAEs and TESAEs were defined as AEs and SAEs with an onset date on or after the first dose of adalimumab in either M12-555 or in prior studies M11-313 or M11-810, excluding AEs and SAEs with onset date during a protocol-defined treatment gap.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | All Adalimumab | Participants who received at least 1 dose of adalimumab (40 mg every week) in M12-555. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| LYMPHADENITIS | Blood and lymphatic system disorders | MedDRA (19.0) | Systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| DIARRHOEA | Gastrointestinal disorders | MedDRA (19.0) | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Global Medical Services | AbbVie | 800-633-9110 |
| ID | Term |
|---|---|
| D017497 | Hidradenitis Suppurativa |
| D000152 | Acne Vulgaris |
| D000038 | Abscess |
| ID | Term |
|---|---|
| D017192 | Skin Diseases, Bacterial |
| D001424 | Bacterial Infections |
| D001423 | Bacterial Infections and Mycoses |
| D007239 | Infections |
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| ID | Term |
|---|---|
| D000068879 | Adalimumab |
| ID | Term |
|---|---|
| D061067 | Antibodies, Monoclonal, Humanized |
| D000911 | Antibodies, Monoclonal |
| D000906 | Antibodies |
| D007136 | Immunoglobulins |
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The percentage of participants with AN counts lowered to 0, 1, or 2 at each visit. LOCF: The last completed evaluation from the previous visit was carried forward to impute missing data at later visits. |
| Weeks 2 (first dose of adalimumab in prior phase 3 study), 4, 8, 12, 16, 20, 24, 36, 48, 60, 72, 84, 96, 108, 120, 132, 144, 156, 168, 180, 192, 204, and 216 |
| Percentage of Participants in the EW/EOW/EW, EW/PBO/EW, and PBO/PBO/EW Analysis Populations Who Achieved AN Count of 0, 1, or 2 at Each Visit | The percentage of participants with AN counts lowered to 0, 1, or 2 at each visit. LOCF: The last completed evaluation from the previous visit was carried forward to impute missing data at later visits. | Entry of M12-555, Weeks 4, 8, 12, 18, 24, 36, 48, 60, 72, 84, 96, 108, 120, 132, 144, 156, 168, 180, and 192 |
| Percentage of Participants in the PBO/EW/EW Analysis Population Who Achieved AN Count of 0, 1, or 2 at Each Visit | The percentage of participants with AN counts lowered to 0, 1, or 2 at each visit. LOCF: The last completed evaluation from the previous visit was carried forward to impute missing data at later visits. | Entry of Period B in prior phase 3 study, Weeks 12, 24, 36, 48, 60, 72, 84, 96, 108, 120, 132, 144, 156, 168, 180, 192, and 204 |
| Modified Sartorius Score: Change From Baseline to Each Visit for Participants in the EW/EW/EW Analysis Population | 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. Higher scores indicate greater severity of HS. A negative change indicates decrease in severity. LOCF: The last completed evaluation from the previous visit was carried forward to impute missing data at later visits. | Baseline (in prior phase 3 study) to Weeks 2 (first dose of adalimumab in prior phase 3 study), 4, 8, 12, 16, 20, 24, 36, 48, 60, 72, 84, 96, 108, 120, 132, 144, 156, 168, 180, 192, 204, and 216 |
| Modified Sartorius Score: Change From Baseline to Each Visit for Participants in the EW/EOW/EW, EW/PBO/EW, and PBO/PBO/EW Analysis Populations | 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. Higher scores indicate greater severity of HS. A negative change indicates decrease in severity. LOCF: The last completed evaluation from the previous visit was carried forward to impute missing data at later visits. | Baseline (in prior phase 3 study) to Entry of M12-555 and Weeks 4, 8, 12, 18, 24, 36, 48, 60, 72, 84, 96, 108, 120, 132, 144, 156, 168, 180, and 192 |
| Modified Sartorius Score: Change From Baseline to Each Visit for Participants in the PBO/EW/EW Analysis Population | 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. Higher scores indicate greater severity of HS. A negative change indicates decrease in severity. LOCF: The last completed evaluation from the previous visit was carried forward to impute missing data at later visits. | Baseline (in prior phase 3 study) to Entry of Period B in prior phase 3 study and Weeks 12, 24, 36, 48, 60, 72, 84, 96, 108, 120, 132, 144, 156, 168, 180, 192, and 204 |
| Percentage of Participants in the EW/EW/EW Analysis Population Achieving Skin Pain NRS30 - At Worst at Each Visit Among Participants With Baseline Skin Pain NRS At Worst ≥ 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 each visit among participants with baseline skin pain NRS - at worst ≥ 3 are presented. Weekly averages of daily assessments were analyzed. LOCF: The last completed evaluation from the previous visit was carried forward to impute missing data at later visits. | Weeks 2 (first dose of adalimumab in prior phase 3 study), 4, 8, 12, 16, 20, 24, 36, 48, 60, 72, 84, 96, 108, 120, 132, 144, 156, 168, 180, and 192 |
| Percentage of Participants in the EW/EOW/EW, EW/PBO/EW, and PBO/PBO/EW Analysis Populations Achieving Skin Pain NRS30 - At Worst at Each Visit Among Participants With Baseline Skin Pain NRS At Worst ≥ 3 | The 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 NRS (NRS30) - at worst at each visit among participants with baseline skin pain NRS - at worst ≥ 3 are presented. Weekly averages of daily assessments were analyzed. LOCF: The last completed evaluation from the previous visit was carried forward to impute missing data at later visits. | Entry of M12-555, and Weeks 4, 8, 12, 18, 24, 36, 48, 60, 72, 84, 96, 108, 120, 132, 144, 156, 168, 180, and 192 |
| Percentage of Participants in the PBO/EW/EW Analysis Population Achieving Skin Pain NRS30 - At Worst at Each Visit Among Participants With Baseline Skin Pain NRS At Worst ≥ 3 | The 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 NRS (NRS30) - at worst at each visit among participants with baseline skin pain NRS - at worst ≥ 3 are presented. Weekly averages of daily assessments were analyzed. LOCF: The last completed evaluation from the previous visit was carried forward to impute missing data at later visits. | Entry of Period B in prior phase 3 study, Weeks 12, 24, 36, 48, 60, 72, 84, 96, 108, 120, 132, 144, 156, 168, 180, 192, and 204 |
| Percentage of Participants in the EW/EW/EW Analysis Population Achieving Skin Pain NRS30 - On Average at Each Visit Among Participants With Baseline Skin Pain NRS On Average ≥ 3 | The 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 NRS (NRS30) - on average at each visit among participants with baseline skin pain NRS - on average ≥ 3 are presented. Weekly averages of daily assessments were analyzed. LOCF: The last completed evaluation from the previous visit was carried forward to impute missing data at later visits. | Weeks 2 (first dose of adalimumab in prior phase 3 study), 4, 8, 12, 16, 20, 24, 36, 48, 60, 72, 84, 96, 108, 120, 132, 144, 156, 168, 180, and 192 |
| Percentage of Participants in the EW/EOW/EW, EW/PBO/EW, and PBO/PBO/EW Analysis Populations Achieving Skin Pain NRS30 - On Average at Each Visit Among Participants With Baseline Skin Pain NRS On Average ≥ 3 | The 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 NRS (NRS30) - on average at each visit among participants with baseline skin pain NRS - on average ≥ 3 are presented. Weekly averages of daily assessments were analyzed. LOCF: The last completed evaluation from the previous visit was carried forward to impute missing data at later visits. | Entry of M12-555, and Weeks 4, 8, 12, 18, 24, 36, 48, 60, 72, 84, 96, 108, 120, 132, 144, 156, 168, 180, and 192 |
| Percentage of Participants in the PBO/EW/EW Analysis Population Achieving Skin Pain NRS30 - On Average at Each Visit Among Participants With Baseline Skin Pain NRS On Average ≥ 3 | The 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 NRS (NRS30) - on average at each visit among participants with baseline skin pain NRS - on average ≥ 3 are presented. Weekly averages of daily assessments were analyzed. LOCF: The last completed evaluation from the previous visit was carried forward to impute missing data at later visits. | Entry of Period B in prior phase 3 study, Weeks 12, 24, 36, 48, 60, 72, 84, 96, 108, 120, 132, 144, 156, 168, 180, 192, and 204 |
| Protocol Deviation |
|
| Withdrew Consent |
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| Lost to Follow-up |
|
| Other |
|
| BG002 | EW/PBO/EW | All participants who received adalimumab 40 mg every week (EW) in Period A and placebo in Period B in the prior Phase 3 studies. |
| BG003 | PBO/EW/EW | All participants who received placebo in Period A and adalimumab 40 mg every week (EW) in Period B in prior phase 3 study M11-313. |
| BG004 | PBO/PBO/EW | All participants who received placebo in both Period A and Period B in prior phase 3 study M11-810. |
| BG005 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| OG001 | EW/EOW/EW | All participants who received adalimumab 40 mg every week (EW) in Period A and 40 mg every other week (EOW) in Period B in the prior Phase 3 studies. |
| OG002 | EW/PBO/EW | All participants who received adalimumab 40 mg every week (EW) in Period A and placebo in Period B in the prior Phase 3 studies. |
|
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| Primary | Percentage of Participants in the PBO/EW/EW Analysis Population Achieving Clinical Response Per HiSCR at Each Visit | Clinical response per HiSCR defined as percent reduction from baseline of the prior phase 3 study in the abscess and inflammatory nodule ≥ 50% (AN50) with no increase in the abscess count and no increase in the draining fistula count. LOCF: The last completed evaluation from the previous visit was carried forward to impute missing data at later visits. | All participants with evaluable data at given time point. | Posted | Number | percentage of participants | Entry of Period B in prior phase 3 study, Weeks 12, 24, 36, 48, 60, 72, 84, 96, 108, 120, 132, 144, 156, 168, 180, 192, and 204 |
|
|
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| Primary | Percentage of Participants in the PBO/PBO/EW Analysis Population Achieving Clinical Response Per HiSCR at Each Visit | Clinical response per HiSCR defined as percent reduction from baseline of the prior phase 3 study in the abscess and inflammatory nodule ≥ 50% (AN50) with no increase in the abscess count and no increase in the draining fistula count. LOCF: The last completed evaluation from the previous visit was carried forward to impute missing data at later visits. | All participants with evaluable data at given time point. | Posted | Number | percentage of participants | Entry of M12-555, Weeks 4, 8, 12, 18, 24, 36, 48, 60, 72, 84, 96, 108, 120, 132, 144, 156, 168, 180, and 192 |
|
|
|
| Primary | Percentage of Participants in the EW/EW/EW Analysis Population Who Achieved Abscess and Inflammatory Nodule (AN) Count of 0, 1, or 2 at Each Visit | The percentage of participants with AN counts lowered to 0, 1, or 2 at each visit. LOCF: The last completed evaluation from the previous visit was carried forward to impute missing data at later visits. | All participants with evaluable data at given time point. | Posted | Number | percentage of participants | Weeks 2 (first dose of adalimumab in prior phase 3 study), 4, 8, 12, 16, 20, 24, 36, 48, 60, 72, 84, 96, 108, 120, 132, 144, 156, 168, 180, 192, 204, and 216 |
|
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| Primary | Percentage of Participants in the EW/EOW/EW, EW/PBO/EW, and PBO/PBO/EW Analysis Populations Who Achieved AN Count of 0, 1, or 2 at Each Visit | The percentage of participants with AN counts lowered to 0, 1, or 2 at each visit. LOCF: The last completed evaluation from the previous visit was carried forward to impute missing data at later visits. | All participants with evaluable data at given time point. | Posted | Number | percentage of participants | Entry of M12-555, Weeks 4, 8, 12, 18, 24, 36, 48, 60, 72, 84, 96, 108, 120, 132, 144, 156, 168, 180, and 192 |
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| Primary | Percentage of Participants in the PBO/EW/EW Analysis Population Who Achieved AN Count of 0, 1, or 2 at Each Visit | The percentage of participants with AN counts lowered to 0, 1, or 2 at each visit. LOCF: The last completed evaluation from the previous visit was carried forward to impute missing data at later visits. | All participants with evaluable data at given time point. | Posted | Number | percentage of participants | Entry of Period B in prior phase 3 study, Weeks 12, 24, 36, 48, 60, 72, 84, 96, 108, 120, 132, 144, 156, 168, 180, 192, and 204 |
|
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| Primary | Modified Sartorius Score: Change From Baseline to Each Visit for Participants in the EW/EW/EW Analysis Population | 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. Higher scores indicate greater severity of HS. A negative change indicates decrease in severity. LOCF: The last completed evaluation from the previous visit was carried forward to impute missing data at later visits. | All participants with evaluable data at given time point. | Posted | Mean | Standard Deviation | units on a scale | Baseline (in prior phase 3 study) to Weeks 2 (first dose of adalimumab in prior phase 3 study), 4, 8, 12, 16, 20, 24, 36, 48, 60, 72, 84, 96, 108, 120, 132, 144, 156, 168, 180, 192, 204, and 216 |
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| Primary | Modified Sartorius Score: Change From Baseline to Each Visit for Participants in the EW/EOW/EW, EW/PBO/EW, and PBO/PBO/EW Analysis Populations | 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. Higher scores indicate greater severity of HS. A negative change indicates decrease in severity. LOCF: The last completed evaluation from the previous visit was carried forward to impute missing data at later visits. | All participants with evaluable data at given time point. | Posted | Mean | Standard Deviation | units on a scale | Baseline (in prior phase 3 study) to Entry of M12-555 and Weeks 4, 8, 12, 18, 24, 36, 48, 60, 72, 84, 96, 108, 120, 132, 144, 156, 168, 180, and 192 |
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| Primary | Modified Sartorius Score: Change From Baseline to Each Visit for Participants in the PBO/EW/EW Analysis Population | 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. Higher scores indicate greater severity of HS. A negative change indicates decrease in severity. LOCF: The last completed evaluation from the previous visit was carried forward to impute missing data at later visits. | All participants with evaluable data at given time point. | Posted | Mean | Standard Deviation | units on a scale | Baseline (in prior phase 3 study) to Entry of Period B in prior phase 3 study and Weeks 12, 24, 36, 48, 60, 72, 84, 96, 108, 120, 132, 144, 156, 168, 180, 192, and 204 |
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| Primary | Percentage of Participants in the EW/EW/EW Analysis Population Achieving Skin Pain NRS30 - At Worst at Each Visit Among Participants With Baseline Skin Pain NRS At Worst ≥ 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 each visit among participants with baseline skin pain NRS - at worst ≥ 3 are presented. Weekly averages of daily assessments were analyzed. LOCF: The last completed evaluation from the previous visit was carried forward to impute missing data at later visits. | All participants with baseline skin pain NRS-at worst ≥3 and with evaluable data at given time point | Posted | Number | percentage of participants | Weeks 2 (first dose of adalimumab in prior phase 3 study), 4, 8, 12, 16, 20, 24, 36, 48, 60, 72, 84, 96, 108, 120, 132, 144, 156, 168, 180, and 192 |
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| Primary | Percentage of Participants in the EW/EOW/EW, EW/PBO/EW, and PBO/PBO/EW Analysis Populations Achieving Skin Pain NRS30 - At Worst at Each Visit Among Participants With Baseline Skin Pain NRS At Worst ≥ 3 | The 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 NRS (NRS30) - at worst at each visit among participants with baseline skin pain NRS - at worst ≥ 3 are presented. Weekly averages of daily assessments were analyzed. LOCF: The last completed evaluation from the previous visit was carried forward to impute missing data at later visits. | All participants with baseline skin pain NRS-at worst ≥3 and with evaluable data at given time point | Posted | Number | percentage of participants | Entry of M12-555, and Weeks 4, 8, 12, 18, 24, 36, 48, 60, 72, 84, 96, 108, 120, 132, 144, 156, 168, 180, and 192 |
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|
|
| Primary | Percentage of Participants in the PBO/EW/EW Analysis Population Achieving Skin Pain NRS30 - At Worst at Each Visit Among Participants With Baseline Skin Pain NRS At Worst ≥ 3 | The 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 NRS (NRS30) - at worst at each visit among participants with baseline skin pain NRS - at worst ≥ 3 are presented. Weekly averages of daily assessments were analyzed. LOCF: The last completed evaluation from the previous visit was carried forward to impute missing data at later visits. | All participants with baseline skin pain NRS-at worst ≥3 and with evaluable data at given time point | Posted | Number | percentage of participants | Entry of Period B in prior phase 3 study, Weeks 12, 24, 36, 48, 60, 72, 84, 96, 108, 120, 132, 144, 156, 168, 180, 192, and 204 |
|
|
|
| Primary | Percentage of Participants in the EW/EW/EW Analysis Population Achieving Skin Pain NRS30 - On Average at Each Visit Among Participants With Baseline Skin Pain NRS On Average ≥ 3 | The 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 NRS (NRS30) - on average at each visit among participants with baseline skin pain NRS - on average ≥ 3 are presented. Weekly averages of daily assessments were analyzed. LOCF: The last completed evaluation from the previous visit was carried forward to impute missing data at later visits. | All participants with baseline skin pain NRS - on average ≥ 3 and with evaluable data at given time point. | Posted | Number | percentage of participants | Weeks 2 (first dose of adalimumab in prior phase 3 study), 4, 8, 12, 16, 20, 24, 36, 48, 60, 72, 84, 96, 108, 120, 132, 144, 156, 168, 180, and 192 |
|
|
|
| Primary | Percentage of Participants in the EW/EOW/EW, EW/PBO/EW, and PBO/PBO/EW Analysis Populations Achieving Skin Pain NRS30 - On Average at Each Visit Among Participants With Baseline Skin Pain NRS On Average ≥ 3 | The 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 NRS (NRS30) - on average at each visit among participants with baseline skin pain NRS - on average ≥ 3 are presented. Weekly averages of daily assessments were analyzed. LOCF: The last completed evaluation from the previous visit was carried forward to impute missing data at later visits. | All participants with baseline skin pain NRS - on average ≥ 3 and with evaluable data at given time point. | Posted | Number | percentage of participants | Entry of M12-555, and Weeks 4, 8, 12, 18, 24, 36, 48, 60, 72, 84, 96, 108, 120, 132, 144, 156, 168, 180, and 192 |
|
|
|
| Primary | Percentage of Participants in the PBO/EW/EW Analysis Population Achieving Skin Pain NRS30 - On Average at Each Visit Among Participants With Baseline Skin Pain NRS On Average ≥ 3 | The 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 NRS (NRS30) - on average at each visit among participants with baseline skin pain NRS - on average ≥ 3 are presented. Weekly averages of daily assessments were analyzed. LOCF: The last completed evaluation from the previous visit was carried forward to impute missing data at later visits. | All participants with baseline skin pain NRS - on average ≥ 3 and with evaluable data at given time point. | Posted | Number | percentage of participants | Entry of Period B in prior phase 3 study, Weeks 12, 24, 36, 48, 60, 72, 84, 96, 108, 120, 132, 144, 156, 168, 180, 192, and 204 |
|
|
|
| 99 |
| 508 |
| 349 |
| 508 |
| ANGINA PECTORIS | Cardiac disorders | MedDRA (19.0) | Systematic Assessment |
|
| CARDIAC ARREST | Cardiac disorders | MedDRA (19.0) | Systematic Assessment |
|
| CARDIAC FAILURE | Cardiac disorders | MedDRA (19.0) | Systematic Assessment |
|
| PALPITATIONS | Cardiac disorders | MedDRA (19.0) | Systematic Assessment |
|
| ODONTOGENIC CYST | Congenital, familial and genetic disorders | MedDRA (19.0) | Systematic Assessment |
|
| AUTOIMMUNE PANCREATITIS | Gastrointestinal disorders | MedDRA (19.0) | Systematic Assessment |
|
| CROHN'S DISEASE | Gastrointestinal disorders | MedDRA (19.0) | Systematic Assessment |
|
| INCARCERATED UMBILICAL HERNIA | Gastrointestinal disorders | MedDRA (19.0) | Systematic Assessment |
|
| PERITONEAL CYST | Gastrointestinal disorders | MedDRA (19.0) | Systematic Assessment |
|
| NON-CARDIAC CHEST PAIN | General disorders | MedDRA (19.0) | Systematic Assessment |
|
| PYREXIA | General disorders | MedDRA (19.0) | Systematic Assessment |
|
| CHOLANGITIS | Hepatobiliary disorders | MedDRA (19.0) | Systematic Assessment |
|
| CHOLELITHIASIS | Hepatobiliary disorders | MedDRA (19.0) | Systematic Assessment |
|
| APPENDICITIS | Infections and infestations | MedDRA (19.0) | Systematic Assessment |
|
| CELLULITIS | Infections and infestations | MedDRA (19.0) | Systematic Assessment |
|
| ERYSIPELAS | Infections and infestations | MedDRA (19.0) | Systematic Assessment |
|
| GROIN ABSCESS | Infections and infestations | MedDRA (19.0) | Systematic Assessment |
|
| INFECTION | Infections and infestations | MedDRA (19.0) | Systematic Assessment |
|
| PERITONITIS | Infections and infestations | MedDRA (19.0) | Systematic Assessment |
|
| PERITONSILLAR ABSCESS | Infections and infestations | MedDRA (19.0) | Systematic Assessment |
|
| PERIUMBILICAL ABSCESS | Infections and infestations | MedDRA (19.0) | Systematic Assessment |
|
| PILONIDAL CYST | Infections and infestations | MedDRA (19.0) | Systematic Assessment |
|
| PNEUMONIA | Infections and infestations | MedDRA (19.0) | Systematic Assessment |
|
| PNEUMONIA CHLAMYDIAL | Infections and infestations | MedDRA (19.0) | Systematic Assessment |
|
| PNEUMONIA VIRAL | Infections and infestations | MedDRA (19.0) | Systematic Assessment |
|
| POSTOPERATIVE WOUND INFECTION | Infections and infestations | MedDRA (19.0) | Systematic Assessment |
|
| PYELONEPHRITIS | Infections and infestations | MedDRA (19.0) | Systematic Assessment |
|
| SEPSIS | Infections and infestations | MedDRA (19.0) | Systematic Assessment |
|
| SEPTIC SHOCK | Infections and infestations | MedDRA (19.0) | Systematic Assessment |
|
| VULVAL ABSCESS | Infections and infestations | MedDRA (19.0) | Systematic Assessment |
|
| ACCIDENTAL OVERDOSE | Injury, poisoning and procedural complications | MedDRA (19.0) | Systematic Assessment |
|
| ANKLE FRACTURE | Injury, poisoning and procedural complications | MedDRA (19.0) | Systematic Assessment |
|
| BURNS SECOND DEGREE | Injury, poisoning and procedural complications | MedDRA (19.0) | Systematic Assessment |
|
| CONTUSION | Injury, poisoning and procedural complications | MedDRA (19.0) | Systematic Assessment |
|
| FOOT FRACTURE | Injury, poisoning and procedural complications | MedDRA (19.0) | Systematic Assessment |
|
| JOINT INJURY | Injury, poisoning and procedural complications | MedDRA (19.0) | Systematic Assessment |
|
| LOWER LIMB FRACTURE | Injury, poisoning and procedural complications | MedDRA (19.0) | Systematic Assessment |
|
| MENISCUS INJURY | Injury, poisoning and procedural complications | MedDRA (19.0) | Systematic Assessment |
|
| PROCEDURAL DIZZINESS | Injury, poisoning and procedural complications | MedDRA (19.0) | Systematic Assessment |
|
| PROCEDURAL NAUSEA | Injury, poisoning and procedural complications | MedDRA (19.0) | Systematic Assessment |
|
| PROCEDURAL PAIN | Injury, poisoning and procedural complications | MedDRA (19.0) | Systematic Assessment |
|
| RADIAL HEAD DISLOCATION | Injury, poisoning and procedural complications | MedDRA (19.0) | Systematic Assessment |
|
| SCAR | Injury, poisoning and procedural complications | MedDRA (19.0) | Systematic Assessment |
|
| TENDON RUPTURE | Injury, poisoning and procedural complications | MedDRA (19.0) | Systematic Assessment |
|
| UPPER LIMB FRACTURE | Injury, poisoning and procedural complications | MedDRA (19.0) | Systematic Assessment |
|
| AUTOANTIBODY POSITIVE | Investigations | MedDRA (19.0) | Systematic Assessment |
|
| BODY TEMPERATURE INCREASED | Investigations | MedDRA (19.0) | Systematic Assessment |
|
| OBESITY | Metabolism and nutrition disorders | MedDRA (19.0) | Systematic Assessment |
|
| TYPE 2 DIABETES MELLITUS | Metabolism and nutrition disorders | MedDRA (19.0) | Systematic Assessment |
|
| BACK PAIN | Musculoskeletal and connective tissue disorders | MedDRA (19.0) | Systematic Assessment |
|
| INTERVERTEBRAL DISC PROTRUSION | Musculoskeletal and connective tissue disorders | MedDRA (19.0) | Systematic Assessment |
|
| JOINT INSTABILITY | Musculoskeletal and connective tissue disorders | MedDRA (19.0) | Systematic Assessment |
|
| MUSCLE SPASMS | Musculoskeletal and connective tissue disorders | MedDRA (19.0) | Systematic Assessment |
|
| BREAST CANCER STAGE III | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (19.0) | Systematic Assessment |
|
| CARDIAC MYXOMA | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (19.0) | Systematic Assessment |
|
| HODGKIN'S DISEASE | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (19.0) | Systematic Assessment |
|
| INVASIVE BREAST CARCINOMA | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (19.0) | Systematic Assessment |
|
| METASTASES TO LIVER | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (19.0) | Systematic Assessment |
|
| PANCREATIC CARCINOMA | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (19.0) | Systematic Assessment |
|
| PAPILLARY CYSTADENOMA LYMPHOMATOSUM | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (19.0) | Systematic Assessment |
|
| SEMINOMA | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (19.0) | Systematic Assessment |
|
| SQUAMOUS CELL CARCINOMA OF SKIN | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (19.0) | Systematic Assessment |
|
| CEREBROVASCULAR ACCIDENT | Nervous system disorders | MedDRA (19.0) | Systematic Assessment |
|
| COMA HEPATIC | Nervous system disorders | MedDRA (19.0) | Systematic Assessment |
|
| HEMIPLEGIA | Nervous system disorders | MedDRA (19.0) | Systematic Assessment |
|
| TRANSIENT ISCHAEMIC ATTACK | Nervous system disorders | MedDRA (19.0) | Systematic Assessment |
|
| ABORTION SPONTANEOUS | Pregnancy, puerperium and perinatal conditions | MedDRA (19.0) | Systematic Assessment |
|
| SUICIDAL IDEATION | Psychiatric disorders | MedDRA (19.0) | Systematic Assessment |
|
| ACUTE KIDNEY INJURY | Renal and urinary disorders | MedDRA (19.0) | Systematic Assessment |
|
| URETERIC OBSTRUCTION | Renal and urinary disorders | MedDRA (19.0) | Systematic Assessment |
|
| DYSFUNCTIONAL UTERINE BLEEDING | Reproductive system and breast disorders | MedDRA (19.0) | Systematic Assessment |
|
| OVARIAN CYST | Reproductive system and breast disorders | MedDRA (19.0) | Systematic Assessment |
|
| PELVIC PROLAPSE | Reproductive system and breast disorders | MedDRA (19.0) | Systematic Assessment |
|
| UTERINE CYST | Reproductive system and breast disorders | MedDRA (19.0) | Systematic Assessment |
|
| ACUTE PULMONARY OEDEMA | Respiratory, thoracic and mediastinal disorders | MedDRA (19.0) | Systematic Assessment |
|
| ACUTE RESPIRATORY FAILURE | Respiratory, thoracic and mediastinal disorders | MedDRA (19.0) | Systematic Assessment |
|
| PLEURISY | Respiratory, thoracic and mediastinal disorders | MedDRA (19.0) | Systematic Assessment |
|
| PNEUMONITIS | Respiratory, thoracic and mediastinal disorders | MedDRA (19.0) | Systematic Assessment |
|
| RESPIRATORY DISTRESS | Respiratory, thoracic and mediastinal disorders | MedDRA (19.0) | Systematic Assessment |
|
| RESPIRATORY FAILURE | Respiratory, thoracic and mediastinal disorders | MedDRA (19.0) | Systematic Assessment |
|
| CUTIS LAXA | Skin and subcutaneous tissue disorders | MedDRA (19.0) | Systematic Assessment |
|
| DERMATITIS CONTACT | Skin and subcutaneous tissue disorders | MedDRA (19.0) | Systematic Assessment |
|
| HIDRADENITIS | Skin and subcutaneous tissue disorders | MedDRA (19.0) | Systematic Assessment |
|
| PUSTULAR PSORIASIS | Skin and subcutaneous tissue disorders | MedDRA (19.0) | Systematic Assessment |
|
| PYODERMA GANGRENOSUM | Skin and subcutaneous tissue disorders | MedDRA (19.0) | Systematic Assessment |
|
| SEXUAL ABUSE | Social circumstances | MedDRA (19.0) | Systematic Assessment |
|
| DEEP VEIN THROMBOSIS | Vascular disorders | MedDRA (19.0) | Systematic Assessment |
|
| HYPERTENSION | Vascular disorders | MedDRA (19.0) | Systematic Assessment |
|
| HYPERTENSIVE CRISIS | Vascular disorders | MedDRA (19.0) | Systematic Assessment |
|
| NAUSEA | Gastrointestinal disorders | MedDRA (19.0) | Systematic Assessment |
|
| PYREXIA | General disorders | MedDRA (19.0) | Systematic Assessment |
|
| BRONCHITIS | Infections and infestations | MedDRA (19.0) | Systematic Assessment |
|
| GASTROENTERITIS | Infections and infestations | MedDRA (19.0) | Systematic Assessment |
|
| INFLUENZA | Infections and infestations | MedDRA (19.0) | Systematic Assessment |
|
| NASOPHARYNGITIS | Infections and infestations | MedDRA (19.0) | Systematic Assessment |
|
| SINUSITIS | Infections and infestations | MedDRA (19.0) | Systematic Assessment |
|
| UPPER RESPIRATORY TRACT INFECTION | Infections and infestations | MedDRA (19.0) | Systematic Assessment |
|
| URINARY TRACT INFECTION | Infections and infestations | MedDRA (19.0) | Systematic Assessment |
|
| ARTHRALGIA | Musculoskeletal and connective tissue disorders | MedDRA (19.0) | Systematic Assessment |
|
| BACK PAIN | Musculoskeletal and connective tissue disorders | MedDRA (19.0) | Systematic Assessment |
|
| HEADACHE | Nervous system disorders | MedDRA (19.0) | Systematic Assessment |
|
| COUGH | Respiratory, thoracic and mediastinal disorders | MedDRA (19.0) | Systematic Assessment |
|
| HIDRADENITIS | Skin and subcutaneous tissue disorders | MedDRA (19.0) | Systematic Assessment |
|
| HYPERTENSION | Vascular disorders | MedDRA (19.0) | 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 |
| D007249 | Inflammation |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D007162 |
| Immunoproteins |
| D001798 | Blood Proteins |
| D011506 | Proteins |
| D000602 | Amino Acids, Peptides, and Proteins |
| D012712 | Serum Globulins |
| D005916 | Globulins |
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