Not provided
| ID | Type | Description | Link |
|---|---|---|---|
| 2005-000095-41 | EudraCT Number |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
The two objectives of this study were to evaluate long-term efficacy and safety of adalimumab treatment in participants who had moderate to severe chronic plaque psoriasis and to evaluate the effectiveness of adalimumab retreatment in participants who had therapeutic response to adalimumab and were then withdrawn from adalimumab treatment.
Study M03-658 was a continuation study for participants with moderate to severe psoriasis who had participated in a prior psoriasis adalimumab study. Study M03-658 consisted of three sequential treatment periods. The first period was Period O, in which participants received open-label treatment with adalimumab (40 mg every other week or 40 mg every week) for a minimum of 104 weeks and a maximum of 252 weeks. Period O was the only period of the study until May 2008, when the subsequent periods were added via amendment to the protocol. At that time, participants who had achieved satisfactory therapeutic response (a Physician's Global Assessment [PGA] of 0, 1, or 2 [clear, minimal, or mild]) were given the opportunity to discontinue from the study or to continue and participate in the subsequent two periods. The second period was Period W, a maximum of 52 weeks, in which participants with a PGA of 2 (mild) or less were withdrawn from adalimumab treatment (i.e., participants received no treatment) until relapse of their psoriasis occurred (defined as a PGA of 3 [moderate] or worse). The third period was Period R, a 16-week period in which participants were retreated with open-label adalimumab (80 mg initial dose followed by 40 mg every other week). Period O was designed to evaluate the first objective regarding long-term efficacy and safety of adalimumab treatment, and Period R was designed to evaluate the effectiveness of adalimumab retreatment following relapse. Specific subsets of the study population that were identified as the populations of interest were the modified intent-to-treat populations for Period W and Period R, and these are described further in the outcome measures.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Adalimumab | Other |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| adalimumab | Drug | 40 mg every other week or 40 mg every week by subcutaneous injection |
|
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Participants With a Physician's Global Assessment of Clear or Minimal at Week 16 of Period R | The Physician's Global Assessment [PGA] was scored by the physician using a 6-point scale (0-5) for the degree of overall lesion severity, where 0 = clear, 1 = minimal, 2 = mild, 3 = moderate, 4 = severe, and 5 = very severe. Subjects with a PGA of Clear or Minimal overall lesion severity had scores of 0 or 1. | Week 16 of Period R |
Not provided
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Participants With a Physician's Global Assessment of Clear or Minimal at Week 60 | The Physician's Global Assessment [PGA] was scored by the physician using a 6-point scale (0-5) for the degree of overall lesion severity, where 0 = clear, 1 = minimal, 2 = mild, 3 = moderate, 4 = severe, and 5 = very severe. Subjects with a PGA of Clear or Minimal overall lesion severity had scores of 0 or 1. |
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Martin Okun, MD, PhD | Abbott | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Site Reference ID/Investigator# 1263 | Birmingham | Alabama | 35205 | United States | ||
| Site Reference ID/Investigator# 1259 |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 21752491 | Derived | Gordon K, Papp K, Poulin Y, Gu Y, Rozzo S, Sasso EH. Long-term efficacy and safety of adalimumab in patients with moderate to severe psoriasis treated continuously over 3 years: results from an open-label extension study for patients from REVEAL. J Am Acad Dermatol. 2012 Feb;66(2):241-51. doi: 10.1016/j.jaad.2010.12.005. Epub 2011 Jul 14. | |
| 21083543 |
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | All Adalimumab Treatment | All participants in the study who received at least one dose of adalimumab. In this study, participants were treated with adalimumab 40 mg every other week (eow) or 40 mg every week by subcutaneous injection (SC) in Period O and then were retreated with open-label adalimumab 40 mg eow SC (after an 80 mg initial dose) in Period R after withdrawal from adalimumab treatment in Period W. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Period O - Open-label Treatment |
|
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Week 60 |
| Percentage of Participants With a Physician's Global Assessment of Clear or Minimal at Week 120 | The Physician's Global Assessment [PGA] was scored by the physician using a 6-point scale (0-5) for the degree of overall lesion severity, where 0 = clear, 1 = minimal, 2 = mild, 3 = moderate, 4 = severe, and 5 = very severe. Subjects with a PGA of Clear or Minimal overall lesion severity had scores of 0 or 1. | Week 120 |
| Percentage of Participants Who Achieved a Psoriasis Area and Severity Index 75 (PASI 75) Response at Week 60 | Psoriasis Area and Severity Index (PASI) scores were calculated from assessments at 4 designated anatomical sites (head, upper extremities, trunk, lower extremities) using both severity and area subscores (i.e., degree of and amount of psoriatic involvement per site). PASI scores range from 0.0 (best) to 72.0 (worst), with the highest score representing complete erythroderma of the severest degree. Positive percent decreases indicate improvement, with the best improvement being 100%. A PASI 75 response was at least a 75% reduction in PASI score from baseline PASI score of the initial study. | Week 60 |
| Percentage of Participants Who Achieved a Psoriasis Area and Severity Index 75 (PASI 75) Response at Week 120 | Psoriasis Area and Severity Index (PASI) scores were calculated from assessments at 4 designated anatomical sites (head, upper extremities, trunk, lower extremities) using both severity and area subscores (i.e., degree of and amount of psoriatic involvement per site). PASI scores range from 0.0 (best) to 72.0 (worst), with the highest score representing complete erythroderma of the severest degree. Positive percent decreases indicate improvement, with the best improvement being 100%. A PASI 75 response was at least a 75% reduction in PASI score from baseline PASI score of the initial study. | Week 120 |
| Time to Relapse in Period W | Relapse of psoriasis was defined as a Physician's Global Assessment (assessment of overall lesion severity) score of greater than or equal to 3 (3=moderate; 4=severe; 5=very severe). | Period W |
| Percentage of Period R Modified Intent-to-Treat Participants Who Relapsed in Period W and Subsequently Had a Physician's Global Assessment of Clear or Minimal at Week 16 of Period R | The Physician's Global Assessment [PGA] was scored by the physician using a 6-point scale (0-5) for the degree of overall lesion severity, where 0 = clear, 1 = minimal, 2 = mild, 3 = moderate, 4 = severe, and 5 = very severe. Subjects with a PGA of Clear or Minimal overall lesion severity had scores of 0 or 1. | Week 16 of Period R |
| Percentage of Period R Modified Intent-to-Treat Participants Who Did Not Relapse in Period W and Subsequently Had a Physician's Global Assessment of Clear or Minimal at Week 16 of Period R | The Physician's Global Assessment [PGA] was scored by the physician using a 6-point scale (0-5) for the degree of overall lesion severity, where 0 = clear, 1 = minimal, 2 = mild, 3 = moderate, 4 = severe, and 5 = very severe. Subjects with a PGA of Clear or Minimal overall lesion severity had scores of 0 or 1. | Week 16 of Period R |
| Buckner 13075 PI |
| Alabama |
| 35233 |
| United States |
| Site Reference ID/Investigator# 2427 | Scottsdale | Arizona | 85251 | United States |
| Site Reference ID/Investigator# 2433 | Tucson | Arizona | 85710 | United States |
| Site Reference ID/Investigator# 100 | Little Rock | Arkansas | 72205 | United States |
| Site Reference ID/Investigator# 1798 | Bakersfield | California | 93309 | United States |
| Site Reference ID/Investigator# 122 | Fresno | California | 93720 | United States |
| Site Reference ID/Investigator# 1669 | Irvine | California | 92697 | United States |
| Site Reference ID/Investigator# 1285 | Oceanside | California | 92056 | United States |
| Site Reference ID/Investigator# 86 | San Diego | California | 92123 | United States |
| Site Reference ID/Investigator# 1679 | Santa Monica | California | 90404 | United States |
| Site Reference ID/Investigator# 1677 | Torrance | California | 90503 | United States |
| Site Reference ID/Investigator# 1269 | Longmont | Colorado | 80501 | United States |
| Site Reference ID/Investigator# 1275 | New Haven | Connecticut | 06511 | United States |
| Site Reference ID/Investigator# 96 | Jacksonville | Florida | 32204 | United States |
| Site Reference ID/Investigator# 2431 | Pinellas Park | Florida | 33781 | United States |
| Site Reference ID/Investigator# 1273 | South Miami | Florida | 33143 | United States |
| Site Reference ID/Investigator# 2432 | West Palm Beach | Florida | 33407 | United States |
| Site Reference ID/Investigator# 98 | Alpharetta | Georgia | 30022 | United States |
| Site Reference ID/Investigator# 1674 | Newnan | Georgia | 30263 | United States |
| Site Reference ID/Investigator# 1670 | Snellville | Georgia | 30078 | United States |
| Site Reference ID/Investigator# 1264 | Chicago | Illinois | 60612 | United States |
| Site Reference ID/Investigator# 1801 | Maywood | Illinois | 60153 | United States |
| Site Reference ID/Investigator# 1681 | Springfield | Illinois | 62702 | United States |
| Site Reference ID/Investigator# 1267 | Indianapolis | Indiana | 46256 | United States |
| Site Reference ID/Investigator# 1671 | Indianapolis | Indiana | 46260 | United States |
| Site Reference ID/Investigator# 1258 | Louisville | Kentucky | 40202 | United States |
| Site Reference ID/Investigator# 1281 | Shreveport | Louisiana | 71103 | United States |
| Site Reference ID/Investigator# 1668 | Andover | Massachusetts | 01810 | United States |
| Site Reference ID/Investigator# 1683 | Boston | Massachusetts | 02114 | United States |
| Site Reference ID/Investigator# 83 | Worcester | Massachusetts | 01610 | United States |
| Site Reference ID/Investigator# 93 | Ann Arbor | Michigan | 48109 | United States |
| Site Reference ID/Investigator# 92 | Fridley | Minnesota | 55432 | United States |
| Site Reference ID/Investigator# 1262 | Minneapolis | Minnesota | 55455 | United States |
| Site Reference ID/Investigator# 1657 | St Louis | Missouri | 63110 | United States |
| Site Reference ID/Investigator# 89 | St Louis | Missouri | 63117 | United States |
| Site Reference ID/Investigator# 1673 | Omaha | Nebraska | 68131 | United States |
| Site Reference ID/Investigator# 2119 | New Brunswick | New Jersey | 08903 | United States |
| Site Reference ID/Investigator# 1672 | New York | New York | 10016 | United States |
| Site Reference ID/Investigator# 1797 | New York | New York | 10025 | United States |
| Site Reference ID/Investigator# 95 | New York | New York | 10029 | United States |
| Site Reference ID/Investigator# 1655 | New York | New York | 10032 | United States |
| Site Reference ID/Investigator# 88 | Rochester | New York | 14623 | United States |
| Site Reference ID/Investigator# 1256 | Williamsville | New York | 14221 | United States |
| Site Reference ID/Investigator# 1266 | Raleigh | North Carolina | 27612 | United States |
| Site Reference ID/Investigator# 1265 | Cincinnati | Ohio | 45219 | United States |
| Site Reference ID/Investigator# 90 | Cleveland | Ohio | 44106 | United States |
| Site Reference ID/Investigator# 2434 | Columbus | Ohio | 43212 | United States |
| Site Reference ID/Investigator# 1260 | Lake Oswego | Oregon | 97035 | United States |
| Site Reference ID/Investigator# 1667 | Portland | Oregon | 97210 | United States |
| Site Reference ID/Investigator# 121 | Portland | Oregon | 97223 | United States |
| Site Reference ID/Investigator# 1323 | Hershey | Pennsylvania | 17033 | United States |
| Site Reference ID/Investigator# 1277 | Philadelphia | Pennsylvania | 19103 | United States |
| Site Reference ID/Investigator# 99 | Johnston | Rhode Island | 02919 | United States |
| Site Reference ID/Investigator# 1676 | Providence | Rhode Island | 02903 | United States |
| Site Reference ID/Investigator# 97 | Greer | South Carolina | 29651 | United States |
| Site Reference ID/Investigator# 5199 | Mt. Pleasant | South Carolina | 29464 | United States |
| Site Reference ID/Investigator# 1800 | Goodlettsville | Tennessee | 37072 | United States |
| Site Reference ID/Investigator# 1282 | Nashville | Tennessee | 37215 | United States |
| Site Reference ID/Investigator# 87 | Dallas | Texas | 75246-1613 | United States |
| Site Reference ID/Investigator# 1279 | Houston | Texas | 77030 | United States |
| Site Reference ID/Investigator# 1665 | San Antonio | Texas | 78229 | United States |
| Site Reference ID/Investigator# 1268 | Tyler | Texas | 75703 | United States |
| Site Reference ID/Investigator# 2079 | Salt Lake City | Utah | 84132 | United States |
| Site Reference ID/Investigator# 123 | Norfolk | Virginia | 23507 | United States |
| Site Reference ID/Investigator# 1653 | Seattle | Washington | 98101 | United States |
| Site Reference ID/Investigator# 2181 | Graz | 8036 | Austria |
| Site Reference ID/Investigator# 2180 | Innsbruck | A-6020 | Austria |
| Site Reference ID/Investigator# 2176 | Vienna | 1090 | Austria |
| Site Reference ID/Investigator# 2554 | Brussels | 1200 | Belgium |
| Site Reference ID/Investigator# 2179 | Edegem | 2650 | Belgium |
| Site Reference ID/Investigator# 1629 | Calgary | Alberta | T2S 3B3 | Canada |
| Site Reference ID/Investigator#1641 | Edmonton | Alberta | T5K 1X3 | Canada |
| Site Reference ID/Investigator# 104 | Vancouver | British Columbia | V5Z 4E8 | Canada |
| Site Reference ID/Investigator# 1635 | St. John's | Newfoundland and Labrador | A1B 4S8 | Canada |
| Site Reference ID/Investigator# 120 | St. John's | Newfoundland and Labrador | A1C 2H5 | Canada |
| Site Reference ID/Investigator# 94 | Halifax | Nova Scotia | B3H 1Z4 | Canada |
| Site Reference ID/Investigator# 1640 | Hamilton | Ontario | L8N 1V6 | Canada |
| Site Reference ID/Investigator# 1636 | London | Ontario | N5X 2P1 | Canada |
| Site Reference ID/Investigator# 1639 | North Bay | Ontario | P1B 3Z7 | Canada |
| Site Reference ID/Investigator# 1633 | Toronto | Ontario | M5V 2T3 | Canada |
| Site Reference ID/Investigator# 1631 | Waterloo | Ontario | N2J 1C4 | Canada |
| Site Reference ID/Investigator# 103 | Windsor | Ontario | N8W 1E6 | Canada |
| Site Reference ID/Investigator# 102 | Montreal | Quebec | H2K 4L5 | Canada |
| Site Reference ID/Investigator# 1637 | Montreal | Quebec | H2K 4L5 | Canada |
| Site Reference ID/Investigator# 101 | Montreal | Quebec | H3H 1V4 | Canada |
| Site Reference ID/Investigator# 1802 | Québec | Quebec | G1V 4X7 | Canada |
| Site Reference ID/Investigator# 1647 | Westmount | Quebec | H3Z 2S6 | Canada |
| Site Reference ID/Investigator# 2553 | Créteil | 94010 | France |
| Site Reference ID/Investigator# 2191 | Nice | 06200 | France |
| Site Reference ID/Investigator# 2190 | Paris | 75475 | France |
| Site Reference ID/Investigator# 2189 | Saint-Etienne | 42055 | France |
| Site Reference ID/Investigator# 2198 | Frankfurt | 60590 | Germany |
| Site Reference ID/Investigator# 2543 | Kiel | 24105 | Germany |
| Site Reference ID/Investigator# 2188 | Münster | 48149 | Germany |
| Site Reference ID/Investigator# 2187 | Tübingen | 72076 | Germany |
| Site Reference ID/Investigator# 2178 | Gdansk | 80-211 | Poland |
| Site Reference ID/Investigator# 2177 | PÅ‚ock | 09-402 | Poland |
| Site Reference ID/Investigator# 2194 | Cagaus | 00725 | Puerto Rico |
| Site Reference ID/Investigator# 5507 | Carolina | 00985 | Puerto Rico |
| Site Reference ID/Investigator# 2182 | Madrid | 28006 | Spain |
| Site Reference ID/Investigator# 2185 | Seville | 41009 | Spain |
| Site Reference ID/Investigator# 2183 | Valencia | 46014 | Spain |
| Site Reference ID/Investigator# 2193 | Geneva | 1211 | Switzerland |
| Papp K, Crowley J, Ortonne JP, Leu J, Okun M, Gupta SR, Gu Y, Langley RG. Adalimumab for moderate to severe chronic plaque psoriasis: efficacy and safety of retreatment and disease recurrence following withdrawal from therapy. Br J Dermatol. 2011 Feb;164(2):434-41. doi: 10.1111/j.1365-2133.2010.10139.x. |
| COMPLETED |
|
| NOT COMPLETED |
|
|
| Period W (Withdrawal) - No Treatment |
|
|
| Period R - Retreatment 16 Weeks |
|
|
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | All Adalimumab Treatment | All participants in the study who received at least one dose of adalimumab. In this study, participants were treated with adalimumab 40 mg every other week (eow) or 40 mg every week by subcutaneous injection (SC) in Period O and then were retreated with open-label adalimumab 40 mg eow SC (after an 80 mg initial dose) in Period R after withdrawal from adalimumab treatment in Period W. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | |||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age Continuous | Mean | Standard Deviation | years |
| ||||||||||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| |||||||||||||||||||||||
| Region of Enrollment | Number | participants |
|
| 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 | ||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Other Pre-specified | Percentage of Participants With a Physician's Global Assessment of Clear or Minimal at Week 60 | The Physician's Global Assessment [PGA] was scored by the physician using a 6-point scale (0-5) for the degree of overall lesion severity, where 0 = clear, 1 = minimal, 2 = mild, 3 = moderate, 4 = severe, and 5 = very severe. Subjects with a PGA of Clear or Minimal overall lesion severity had scores of 0 or 1. | A subset of the All Adalimumab Treatment population who initiated treatment with an adalimumab 40 mg every other week (eow) injection or placebo injection in a prior study. Results were analyzed using Last Observation Carried Forward (LOCF) imputation for missing values. | Posted | Number | percentage of participants | Week 60 |
|
|
| ||||||||||||||||||||||||||
| Other Pre-specified | Percentage of Participants With a Physician's Global Assessment of Clear or Minimal at Week 120 | The Physician's Global Assessment [PGA] was scored by the physician using a 6-point scale (0-5) for the degree of overall lesion severity, where 0 = clear, 1 = minimal, 2 = mild, 3 = moderate, 4 = severe, and 5 = very severe. Subjects with a PGA of Clear or Minimal overall lesion severity had scores of 0 or 1. | A subset of the All Adalimumab Treatment population who initiated treatment with an adalimumab 40 mg every other week (eow) injection or placebo injection in a prior study. Results were analyzed using Last Observation Carried Forward (LOCF) imputation for missing values. | Posted | Number | percentage of participants | Week 120 |
|
| |||||||||||||||||||||||||||
| Primary | Percentage of Participants With a Physician's Global Assessment of Clear or Minimal at Week 16 of Period R | The Physician's Global Assessment [PGA] was scored by the physician using a 6-point scale (0-5) for the degree of overall lesion severity, where 0 = clear, 1 = minimal, 2 = mild, 3 = moderate, 4 = severe, and 5 = very severe. Subjects with a PGA of Clear or Minimal overall lesion severity had scores of 0 or 1. | The Period R Modified Intent-to-Treat population included 178 participants who relapsed and 107 participants who did not relapse in Period W when therapy was withdrawn; all received Period R adalimumab 40 mg every other week (after an 80 mg initial dose). Results were analyzed using non-responder imputation (NRI) for missing values. | Posted | Number | percentage of participants | Week 16 of Period R |
|
| |||||||||||||||||||||||||||
| Other Pre-specified | Percentage of Participants Who Achieved a Psoriasis Area and Severity Index 75 (PASI 75) Response at Week 60 | Psoriasis Area and Severity Index (PASI) scores were calculated from assessments at 4 designated anatomical sites (head, upper extremities, trunk, lower extremities) using both severity and area subscores (i.e., degree of and amount of psoriatic involvement per site). PASI scores range from 0.0 (best) to 72.0 (worst), with the highest score representing complete erythroderma of the severest degree. Positive percent decreases indicate improvement, with the best improvement being 100%. A PASI 75 response was at least a 75% reduction in PASI score from baseline PASI score of the initial study. | A subset of the All Adalimumab Treatment population who initiated treatment with an adalimumab 40 mg every other week (eow) injection or placebo injection in a prior study. Results were analyzed using Last Observation Carried Forward (LOCF) imputation for missing values. | Posted | Number | percentage of participants | Week 60 |
|
| |||||||||||||||||||||||||||
| Other Pre-specified | Percentage of Participants Who Achieved a Psoriasis Area and Severity Index 75 (PASI 75) Response at Week 120 | Psoriasis Area and Severity Index (PASI) scores were calculated from assessments at 4 designated anatomical sites (head, upper extremities, trunk, lower extremities) using both severity and area subscores (i.e., degree of and amount of psoriatic involvement per site). PASI scores range from 0.0 (best) to 72.0 (worst), with the highest score representing complete erythroderma of the severest degree. Positive percent decreases indicate improvement, with the best improvement being 100%. A PASI 75 response was at least a 75% reduction in PASI score from baseline PASI score of the initial study. | A subset of the the All Adalimumab Treatment population who initiated treatment with an adalimumab 40 mg every other week (eow) injection or placebo injection in a prior study. Results were analyzed using Last Observation Carried Forward (LOCF) imputation for missing values. | Posted | Number | percentage of participants | Week 120 |
|
| |||||||||||||||||||||||||||
| Other Pre-specified | Time to Relapse in Period W | Relapse of psoriasis was defined as a Physician's Global Assessment (assessment of overall lesion severity) score of greater than or equal to 3 (3=moderate; 4=severe; 5=very severe). | Participants in the Period W Modified Intent-to-Treat Population who had relapsed (defined by a PGA of greater than or equal to 3) during Period W and had at least one post-baseline PGA assessment in Period W. | Posted | Median | 95% Confidence Interval | days | Period W |
|
| ||||||||||||||||||||||||||
| Other Pre-specified | Percentage of Period R Modified Intent-to-Treat Participants Who Relapsed in Period W and Subsequently Had a Physician's Global Assessment of Clear or Minimal at Week 16 of Period R | The Physician's Global Assessment [PGA] was scored by the physician using a 6-point scale (0-5) for the degree of overall lesion severity, where 0 = clear, 1 = minimal, 2 = mild, 3 = moderate, 4 = severe, and 5 = very severe. Subjects with a PGA of Clear or Minimal overall lesion severity had scores of 0 or 1. | Participants in the Period R mITT population who had relapsed (had a PGA of greater than or equal to 3) with adalimumab treatment withdrawal during Period W. Results were analyzed using non-responder imputation (NRI) for missing values. | Posted | Number | percentage of participants | Week 16 of Period R |
|
| |||||||||||||||||||||||||||
| Other Pre-specified | Percentage of Period R Modified Intent-to-Treat Participants Who Did Not Relapse in Period W and Subsequently Had a Physician's Global Assessment of Clear or Minimal at Week 16 of Period R | The Physician's Global Assessment [PGA] was scored by the physician using a 6-point scale (0-5) for the degree of overall lesion severity, where 0 = clear, 1 = minimal, 2 = mild, 3 = moderate, 4 = severe, and 5 = very severe. Subjects with a PGA of Clear or Minimal overall lesion severity had scores of 0 or 1. | Participants in the Period R mITT population who did not relapse (did not have a PGA greater than or equal to 3) with adalimumab treatment withdrawal during Period W. Results were analyzed using non-responder imputation (NRI) for missing values. | Posted | Number | percentage of participants | Week 16 of Period R |
|
|
2,095 days(approximately 5.7 years), including adalimumab exposure in prior studies
Adverse events reported from the start of adalimumab treatment until 70 days after discontinuation of adalimumab treatment were defined as treatment-emergent and are displayed.
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 | All Adalimumab Treatment | All participants in the study who received at least one dose of adalimumab. In this study, participants were treated with adalimumab 40 mg every other week (eow) or 40 mg every week by subcutaneous injection (SC) in Period O and then were retreated with open-label adalimumab 40 mg eow SC (after an 80 mg initial dose) in Period R after withdrawal from adalimumab treatment in Period W. | 189 | 1,468 | 1,036 | 1,468 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anaemia | Blood and lymphatic system disorders | MedDRA 12.0 | Systematic Assessment |
| |
| Thrombocytopenia | Blood and lymphatic system disorders | MedDRA 12.0 | Systematic Assessment |
| |
| Acute myocardial infarction | Cardiac disorders | MedDRA 12.0 | Systematic Assessment |
| |
| Arrhythmia | Cardiac disorders | MedDRA 12.0 | Systematic Assessment |
| |
| Arteriosclerosis coronary artery | Cardiac disorders | MedDRA 12.0 | Systematic Assessment |
| |
| Atrial fibrillation | Cardiac disorders | MedDRA 12.0 | Systematic Assessment |
| |
| Cardiac arrest | Cardiac disorders | MedDRA 12.0 | Systematic Assessment |
| |
| Cardiac failure congestive | Cardiac disorders | MedDRA 12.0 | Systematic Assessment |
| |
| Cardiac tamponade | Cardiac disorders | MedDRA 12.0 | Systematic Assessment |
| |
| Coronary artery disease | Cardiac disorders | MedDRA 12.0 | Systematic Assessment |
| |
| Coronary artery occlusion | Cardiac disorders | MedDRA 12.0 | Systematic Assessment |
| |
| Mitral valve incompetence | Cardiac disorders | MedDRA 12.0 | Systematic Assessment |
| |
| Myocardial infarction | Cardiac disorders | MedDRA 12.0 | Systematic Assessment |
| |
| Supraventricular tachycardia | Cardiac disorders | MedDRA 12.0 | Systematic Assessment |
| |
| Tachycardia paroxysmal | Cardiac disorders | MedDRA 12.0 | Systematic Assessment |
| |
| Ventricular tachycardia | Cardiac disorders | MedDRA 12.0 | Systematic Assessment |
| |
| Otosclerosis | Ear and labyrinth disorders | MedDRA 12.0 | Systematic Assessment |
| |
| Vertigo positional | Ear and labyrinth disorders | MedDRA 12.0 | Systematic Assessment |
| |
| Abdominal adhesions | Gastrointestinal disorders | MedDRA 12.0 | Systematic Assessment |
| |
| Abdominal hernia | Gastrointestinal disorders | MedDRA 12.0 | Systematic Assessment |
| |
| Abdominal pain lower | Gastrointestinal disorders | MedDRA 12.0 | Systematic Assessment |
| |
| Ascites | Gastrointestinal disorders | MedDRA 12.0 | Systematic Assessment |
| |
| Diverticular perforation | Gastrointestinal disorders | MedDRA 12.0 | Systematic Assessment |
| |
| Diverticulum | Gastrointestinal disorders | MedDRA 12.0 | Systematic Assessment |
| |
| Enterocele | Gastrointestinal disorders | MedDRA 12.0 | Systematic Assessment |
| |
| Gastrointestinal ulcer haemorrhage | Gastrointestinal disorders | MedDRA 12.0 | Systematic Assessment |
| |
| Gastrooesophageal reflux disease | Gastrointestinal disorders | MedDRA 12.0 | Systematic Assessment |
| |
| Intra-abdominal haematoma | Gastrointestinal disorders | MedDRA 12.0 | Systematic Assessment |
| |
| Nausea | Gastrointestinal disorders | MedDRA 12.0 | Systematic Assessment |
| |
| Oesophageal rupture | Gastrointestinal disorders | MedDRA 12.0 | Systematic Assessment |
| |
| Pancreatitis | Gastrointestinal disorders | MedDRA 12.0 | Systematic Assessment |
| |
| Salivary gland mass | Gastrointestinal disorders | MedDRA 12.0 | Systematic Assessment |
| |
| Small intestinal obstruction | Gastrointestinal disorders | MedDRA 12.0 | Systematic Assessment |
| |
| Umbilical hernia | Gastrointestinal disorders | MedDRA 12.0 | Systematic Assessment |
| |
| Upper gastrointestinal haemorrhage | Gastrointestinal disorders | MedDRA 12.0 | Systematic Assessment |
| |
| Vomiting | Gastrointestinal disorders | MedDRA 12.0 | Systematic Assessment |
| |
| Chest discomfort | General disorders | MedDRA 12.0 | Systematic Assessment |
| |
| Chest pain | General disorders | MedDRA 12.0 | Systematic Assessment |
| |
| Localised oedema | General disorders | MedDRA 12.0 | Systematic Assessment |
| |
| Oedema peripheral | General disorders | MedDRA 12.0 | Systematic Assessment |
| |
| Bile duct stone | Hepatobiliary disorders | MedDRA 12.0 | Systematic Assessment |
| |
| Colecystitis | Hepatobiliary disorders | MedDRA 12.0 | Systematic Assessment |
| |
| Cholelithiasis | Hepatobiliary disorders | MedDRA 12.0 | Systematic Assessment |
| |
| Hepatic cirrhosis | Hepatobiliary disorders | MedDRA 12.0 | Systematic Assessment |
| |
| Abscess | Infections and infestations | MedDRA 12.0 | Systematic Assessment |
| |
| Abscess limb | Infections and infestations | MedDRA 12.0 | Systematic Assessment |
| |
| Appendicitis | Infections and infestations | MedDRA 12.0 | Systematic Assessment |
| |
| Appendicitis perforated | Infections and infestations | MedDRA 12.0 | Systematic Assessment |
| |
| Arthritis bacterial | Infections and infestations | MedDRA 12.0 | Systematic Assessment |
| |
| Cellulitis | Infections and infestations | MedDRA 12.0 | Systematic Assessment |
| |
| Disseminated tuberculosis | Infections and infestations | MedDRA 12.0 | Systematic Assessment |
| |
| Diverticulitis | Infections and infestations | MedDRA 12.0 | Systematic Assessment |
| |
| Epiglottitis | Infections and infestations | MedDRA 12.0 | Systematic Assessment |
| |
| Gastroenteritis | Infections and infestations | MedDRA 12.0 | Systematic Assessment |
| |
| Gastroenteritis escherichia coli | Infections and infestations | MedDRA 12.0 | Systematic Assessment |
| |
| Gastroenteritis viral | Infections and infestations | MedDRA 12.0 | Systematic Assessment |
| |
| Haematoma infection | Infections and infestations | MedDRA 12.0 | Systematic Assessment |
| |
| Hepatitis C | Infections and infestations | MedDRA 12.0 | Systematic Assessment |
| |
| Human ehrlichiosis | Infections and infestations | MedDRA 12.0 | Systematic Assessment |
| |
| Lobar pneumonia | Infections and infestations | MedDRA 12.0 | Systematic Assessment |
| |
| Meningitis viral | Infections and infestations | MedDRA 12.0 | Systematic Assessment |
| |
| Necrotising pasciitis | Infections and infestations | MedDRA 12.0 | Systematic Assessment |
| |
| Osteomyelitis | Infections and infestations | MedDRA 12.0 | Systematic Assessment |
| |
| Paratyphoid fever | Infections and infestations | MedDRA 12.0 | Systematic Assessment |
| |
| Peritonsillar abscess | Infections and infestations | MedDRA 12.0 | Systematic Assessment |
| |
| Pharyngitis streptococcal | Infections and infestations | MedDRA 12.0 | Systematic Assessment |
| |
| Pneumonia | Infections and infestations | MedDRA 12.0 | Systematic Assessment |
| |
| Pneumonia legionella | Infections and infestations | MedDRA 12.0 | Systematic Assessment |
| |
| Post procedural infection | Infections and infestations | MedDRA 12.0 | Systematic Assessment |
| |
| Pulmonary tuberculosis | Infections and infestations | MedDRA 12.0 | Systematic Assessment |
| |
| Pyelonephritis | Infections and infestations | MedDRA 12.0 | Systematic Assessment |
| |
| Sepsis | Infections and infestations | MedDRA 12.0 | Systematic Assessment |
| |
| Staphylococcal abscess | Infections and infestations | MedDRA 12.0 | Systematic Assessment |
| |
| Staphylococcal infection | Infections and infestations | MedDRA 12.0 | Systematic Assessment |
| |
| Streptococcal infection | Infections and infestations | MedDRA 12.0 | Systematic Assessment |
| |
| Subcutaneous abscess | Infections and infestations | MedDRA 12.0 | Systematic Assessment |
| |
| Tuberculosis | Infections and infestations | MedDRA 12.0 | Systematic Assessment |
| |
| Viral upper respiratory tract infection | Infections and infestations | MedDRA 12.0 | Systematic Assessment |
| |
| Anaemia postoperative | Injury, poisoning and procedural complications | MedDRA 12.0 | Systematic Assessment |
| |
| Ankle fracture | Injury, poisoning and procedural complications | MedDRA 12.0 | Systematic Assessment |
| |
| Device failure | Injury, poisoning and procedural complications | MedDRA 12.0 | Systematic Assessment |
| |
| Fall | Injury, poisoning and procedural complications | MedDRA 12.0 | Systematic Assessment |
| |
| Femur fracture | Injury, poisoning and procedural complications | MedDRA 12.0 | Systematic Assessment |
| |
| Humerus fracture | Injury, poisoning and procedural complications | MedDRA 12.0 | Systematic Assessment |
| |
| Injury | Injury, poisoning and procedural complications | MedDRA 12.0 | Systematic Assessment |
| |
| Postprocedural haemorrhage | Injury, poisoning and procedural complications | MedDRA 12.0 | Systematic Assessment |
| |
| Procedural pain | Injury, poisoning and procedural complications | MedDRA 12.0 | Systematic Assessment |
| |
| Rib fracture | Injury, poisoning and procedural complications | MedDRA 12.0 | Systematic Assessment |
| |
| Seroma | Injury, poisoning and procedural complications | MedDRA 12.0 | Systematic Assessment |
| |
| Soft tissue injury | Injury, poisoning and procedural complications | MedDRA 12.0 | Systematic Assessment |
| |
| Tendon rupture | Injury, poisoning and procedural complications | MedDRA 12.0 | Systematic Assessment |
| |
| Central obesity | Metabolism and nutrition disorders | MedDRA 12.0 | Systematic Assessment |
| |
| Hypokalaemia | Metabolism and nutrition disorders | MedDRA 12.0 | Systematic Assessment |
| |
| Metabolic syndrome | Metabolism and nutrition disorders | MedDRA 12.0 | Systematic Assessment |
| |
| Obesity | Metabolism and nutrition disorders | MedDRA 12.0 | Systematic Assessment |
| |
| Arthritis | Musculoskeletal and connective tissue disorders | MedDRA 12.0 | Systematic Assessment |
| |
| Exostosis | Musculoskeletal and connective tissue disorders | MedDRA 12.0 | Systematic Assessment |
| |
| Intervertebral disc compression | Musculoskeletal and connective tissue disorders | MedDRA 12.0 | Systematic Assessment |
| |
| Osteoarthritis | Musculoskeletal and connective tissue disorders | MedDRA 12.0 | Systematic Assessment |
| |
| Osteonecrosis | Musculoskeletal and connective tissue disorders | MedDRA 12.0 | Systematic Assessment |
| |
| Rhabdomyolysis | Musculoskeletal and connective tissue disorders | MedDRA 12.0 | Systematic Assessment |
| |
| Scoliosis | Musculoskeletal and connective tissue disorders | MedDRA 12.0 | Systematic Assessment |
| |
| Basal cell carcinoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 12.0 | Systematic Assessment |
| |
| Breast cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 12.0 | Systematic Assessment |
| |
| Endometrial adenoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 12.0 | Systematic Assessment |
| |
| Keratoacanthoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 12.0 | Systematic Assessment |
| |
| Lip and/or oral cavity cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 12.0 | Systematic Assessment |
| |
| Malignant melanoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 12.0 | Systematic Assessment |
| |
| Malignant melanoma in situ | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 12.0 | Systematic Assessment |
| |
| Melanocytic naevus | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 12.0 | Systematic Assessment |
| |
| Meningioma benign | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 12.0 | Systematic Assessment |
| |
| Neuroendocrine tumour | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 12.0 | Systematic Assessment |
| |
| Ovarian adenoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 12.0 | Systematic Assessment |
| |
| Prostate cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 12.0 | Systematic Assessment |
| |
| Rectal cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 12.0 | Systematic Assessment |
| |
| Renal cell carcinoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 12.0 | Systematic Assessment |
| |
| Small cell lung cancer stage unspecified | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 12.0 | Systematic Assessment |
| |
| Superficial spreading melanoma stage unspecified | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 12.0 | Systematic Assessment |
| |
| Testis cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 12.0 | Systematic Assessment |
| |
| Throat cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 12.0 | Systematic Assessment |
| |
| Thyroid adenoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 12.0 | Systematic Assessment |
| |
| Thyroid cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 12.0 | Systematic Assessment |
| |
| Tongue neoplasm malignant stage unspecified | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 12.0 | Systematic Assessment |
| |
| Uterine leiomyoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 12.0 | Systematic Assessment |
| |
| Agnosia | Nervous system disorders | MedDRA 12.0 | Systematic Assessment |
| |
| Amyotrophic lateral sclerosis | Nervous system disorders | MedDRA 12.0 | Systematic Assessment |
| |
| Brain mass | Nervous system disorders | MedDRA 12.0 | Systematic Assessment |
| |
| Cerebral haemorrhage | Nervous system disorders | MedDRA 12.0 | Systematic Assessment |
| |
| Cerebrovascular accident | Nervous system disorders | MedDRA 12.0 | Systematic Assessment |
| |
| Cervicobrachial syndrome | Nervous system disorders | MedDRA 12.0 | Systematic Assessment |
| |
| Convulsion | Nervous system disorders | MedDRA 12.0 | Systematic Assessment |
| |
| Diabetic ketoacidotic hyperglycaemic coma | Nervous system disorders | MedDRA 12.0 | Systematic Assessment |
| |
| Hypoxic encephalopathy | Nervous system disorders | MedDRA 12.0 | Systematic Assessment |
| |
| Neuralgia | Nervous system disorders | MedDRA 12.0 | Systematic Assessment |
| |
| Paresis | Nervous system disorders | MedDRA 12.0 | Systematic Assessment |
| |
| Presyncope | Nervous system disorders | MedDRA 12.0 | Systematic Assessment |
| |
| Subarachnoid haemorrhage | Nervous system disorders | MedDRA 12.0 | Systematic Assessment |
| |
| Syncope | Nervous system disorders | MedDRA 12.0 | Systematic Assessment |
| |
| Cerebellar infarction | Nervous system disorders | MedDRA 12.0 | Systematic Assessment |
| |
| Abortion spontaneous | Pregnancy, puerperium and perinatal conditions | MedDRA 12.0 | Systematic Assessment |
| |
| Alcohol withdrawal syndrome | Psychiatric disorders | MedDRA 12.0 | Systematic Assessment |
| |
| Anxiety | Psychiatric disorders | MedDRA 12.0 | Systematic Assessment |
| |
| Bipolar I disorder | Psychiatric disorders | MedDRA 12.0 | Systematic Assessment |
| |
| Completed suicide | Psychiatric disorders | MedDRA 12.0 | Systematic Assessment |
| |
| Cyclothymic disorder | Psychiatric disorders | MedDRA 12.0 | Systematic Assessment |
| |
| Depression | Psychiatric disorders | MedDRA 12.0 | Systematic Assessment |
| |
| Depression suicidal | Psychiatric disorders | MedDRA 12.0 | Systematic Assessment |
| |
| Psychotic disorder | Psychiatric disorders | MedDRA 12.0 | Systematic Assessment |
| |
| Calculus ureteric | Renal and urinary disorders | MedDRA 12.0 | Systematic Assessment |
| |
| Nephrolithiasis | Renal and urinary disorders | MedDRA 12.0 | Systematic Assessment |
| |
| Renal colic | Renal and urinary disorders | MedDRA 12.0 | Systematic Assessment |
| |
| Renal failure | Renal and urinary disorders | MedDRA 12.0 | Systematic Assessment |
| |
| Renal failure acute | Renal and urinary disorders | MedDRA 12.0 | Systematic Assessment |
| |
| Renal failure chronic | Renal and urinary disorders | MedDRA 12.0 | Systematic Assessment |
| |
| Urinary incontinence | Renal and urinary disorders | MedDRA 12.0 | Systematic Assessment |
| |
| Urinary retention | Renal and urinary disorders | MedDRA 12.0 | Systematic Assessment |
| |
| Vesicoureteric reflux | Renal and urinary disorders | MedDRA 12.0 | Systematic Assessment |
| |
| Bartholinitis | Reproductive system and breast disorders | MedDRA 12.0 | Systematic Assessment |
| |
| Breast enlargement | Reproductive system and breast disorders | MedDRA 12.0 | Systematic Assessment |
| |
| Cervical dysplasia | Reproductive system and breast disorders | MedDRA 12.0 | Systematic Assessment |
| |
| Cystocele | Reproductive system and breast disorders | MedDRA 12.0 | Systematic Assessment |
| |
| Menorrhagia | Reproductive system and breast disorders | MedDRA 12.0 | Systematic Assessment |
| |
| Ovarian cyst | Reproductive system and breast disorders | MedDRA 12.0 | Systematic Assessment |
| |
| Perineal fistula | Reproductive system and breast disorders | MedDRA 12.0 | Systematic Assessment |
| |
| Rectocele | Reproductive system and breast disorders | MedDRA 12.0 | Systematic Assessment |
| |
| Uterine prolapse | Reproductive system and breast disorders | MedDRA 12.0 | Systematic Assessment |
| |
| Asthma | Respiratory, thoracic and mediastinal disorders | MedDRA 12.0 | Systematic Assessment |
| |
| Chronic obstructive pulmonary disease | Respiratory, thoracic and mediastinal disorders | MedDRA 12.0 | Systematic Assessment |
| |
| Emphysema | Respiratory, thoracic and mediastinal disorders | MedDRA 12.0 | Systematic Assessment |
| |
| Nasal septum deviation | Respiratory, thoracic and mediastinal disorders | MedDRA 12.0 | Systematic Assessment |
| |
| Pleural effusion | Respiratory, thoracic and mediastinal disorders | MedDRA 12.0 | Systematic Assessment |
| |
| Pneumonia aspiration | Respiratory, thoracic and mediastinal disorders | MedDRA 12.0 | Systematic Assessment |
| |
| Pneumothorax | Respiratory, thoracic and mediastinal disorders | MedDRA 12.0 | Systematic Assessment |
| |
| Pulmonary embolism | Respiratory, thoracic and mediastinal disorders | MedDRA 12.0 | Systematic Assessment |
| |
| Tonsillar hypertrophy | Respiratory, thoracic and mediastinal disorders | MedDRA 12.0 | Systematic Assessment |
| |
| Dermatitis allergic | Skin and subcutaneous tissue disorders | MedDRA 12.0 | Systematic Assessment |
| |
| Dermatitis contact | Skin and subcutaneous tissue disorders | MedDRA 12.0 | Systematic Assessment |
| |
| Excessive skin | Skin and subcutaneous tissue disorders | MedDRA 12.0 | Systematic Assessment |
| |
| Subcutaneous emphysema | Skin and subcutaneous tissue disorders | MedDRA 12.0 | Systematic Assessment |
| |
| Physical abuse | Social circumstances | MedDRA 12.0 | Systematic Assessment |
| |
| Abortion induced | Surgical and medical procedures | MedDRA 12.0 | Systematic Assessment |
| |
| Aortic aneurysm | Vascular disorders | MedDRA 12.0 | Systematic Assessment |
| |
| Aortic stenosis | Vascular disorders | MedDRA 12.0 | Systematic Assessment |
| |
| Arterial stenosis | Vascular disorders | MedDRA 12.0 | Systematic Assessment |
| |
| Deep vein thrombosis | Vascular disorders | MedDRA 12.0 | Systematic Assessment |
| |
| Haemorrhage | Vascular disorders | MedDRA 12.0 | Systematic Assessment |
| |
| Orthostatic hypotension | Vascular disorders | MedDRA 12.0 | Systematic Assessment |
| |
| Venous insufficiency | Vascular disorders | MedDRA 12.0 | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Diarrhoea | Gastrointestinal disorders | MedDRA 12.0 | Systematic Assessment |
| |
| Nausea | Gastrointestinal disorders | MedDRA 12.0 | Systematic Assessment |
| |
| Injection site reaction | General disorders | MedDRA 12.0 | Systematic Assessment |
| |
| Bronchitis | Infections and infestations | MedDRA 12.0 | Systematic Assessment |
| |
| Influenza | Infections and infestations | MedDRA 12.0 | Systematic Assessment |
| |
| Nasopharyngitis | Infections and infestations | MedDRA 12.0 | Systematic Assessment |
| |
| Sinusitis | Infections and infestations | MedDRA 12.0 | Systematic Assessment |
| |
| Upper respiratory tract infection | Infections and infestations | MedDRA 12.0 | Systematic Assessment |
| |
| Muscle strain | Injury, poisoning and procedural complications | MedDRA 12.0 | Systematic Assessment |
| |
| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA 12.0 | Systematic Assessment |
| |
| Back pain | Musculoskeletal and connective tissue disorders | MedDRA 12.0 | Systematic Assessment |
| |
| Pain in extremity | Musculoskeletal and connective tissue disorders | MedDRA 12.0 | Systematic Assessment |
| |
| Headache | Nervous system disorders | MedDRA 12.0 | Systematic Assessment |
| |
| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA 12.0 | Systematic Assessment |
| |
| Oropharyngeal pain | Respiratory, thoracic and mediastinal disorders | MedDRA 12.0 | Systematic Assessment |
| |
| Hypertension | Vascular disorders | MedDRA 12.0 | Systematic Assessment |
|
Abbott 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. Abbott 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 Abbott needs to secure patent or proprietary protection.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Global Medical Services | Abbott | 800-633-9110 |
| ID | Term |
|---|---|
| D011565 | Psoriasis |
| ID | Term |
|---|---|
| D017444 | Skin Diseases, Papulosquamous |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| D000068879 | Adalimumab |
| ID | Term |
|---|---|
| D061067 | Antibodies, Monoclonal, Humanized |
| D000911 | Antibodies, Monoclonal |
| D000906 | Antibodies |
| D007136 | Immunoglobulins |
| D007162 | Immunoproteins |
| D001798 | Blood Proteins |
| D011506 | Proteins |
| D000602 | Amino Acids, Peptides, and Proteins |
| D012712 | Serum Globulins |
| D005916 | Globulins |
Not provided
Not provided
| Withdrawal by Subject |
|
| Relapse (PGA >= 3) |
|
| Period W Close-out |
|
| Administrative reasons |
|
| Other reasons |
|
| Withdrawal by Subject |
|
| Other reasons |
|
| Austria |
|
| Belgium |
|
| France |
|
| Switzerland |
|
| Spain |
|
| Poland |
|
| Germany |
|
|
|
|
|
|
|
|
|
|