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The present survey was conducted to evaluate the effectiveness and safety of treatment with adalimumab during the 52-week period following completion of the treatment period in Study NCT00870467 (M06-859) in participants who continued treatment with adalimumab for 52 weeks.
This survey was conducted to assess the risk and benefit of continuing or discontinuing biological therapy with adalimumab (Humira) during the 52-week period following completion of the treatment period in Study NCT00870467 (M06-859).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Adalimumab | Participants who continued adalimumab treatment after completion of Study NCT00870467 (M06-859) | ||
| Non-Adalimumab | Participants who discontinued adalimumab treatment after completion of Study NCT00870467(M06-859) |
Not provided
| Measure | Description | Time Frame |
|---|---|---|
| Disease Activity Score (DAS28) | The Disease Activity Score (DAS28) is a combined index used to measure disease activity in participants with rheumatoid arthritis. Calculation of the DAS28 score used the tender joint count (28 joints), swollen joint count (28 joints), patient's global assessment of disease activity, and the erythrocyte sedimentation rate (ESR). DAS 28 (ESR) scores range from 0 (no disease activity) to 9 (maximal disease activity); decrease is indicative of improvement in disease activity. | Weeks 0, 26, and 52 |
| Measure | Description | Time Frame |
|---|---|---|
| Matrix Metalloprotease-3 (MMP-3) | MMP-3 level in serum. Positive = >/= 121.0 ng/mL (male) and 59.7 ng/mL (female) | Weeks 0, 26, and 52 |
| Modified Total Sharp Score (mTSS) Change From Week 0 to Week 52 |
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Inclusion Criteria:
Exclusion Criteria:
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The participants were patients who continued treatment with adalimumab until the end of the treatment period in the NCT00870467(M06-859) study.
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| Name | Affiliation | Role |
|---|---|---|
| Aki Kuroki | AbbVie | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Site Reference ID/Investigator# 54680 | Anjo | Japan | ||||
| Site Reference ID/Investigator# 54677 |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 26925252 | Derived | Tanaka Y, Yamanaka H, Ishiguro N, Miyasaka N, Kawana K, Hiramatsu K, Takeuchi T. Adalimumab discontinuation in patients with early rheumatoid arthritis who were initially treated with methotrexate alone or in combination with adalimumab: 1 year outcomes of the HOPEFUL-2 study. RMD Open. 2016 Feb 18;2(1):e000189. doi: 10.1136/rmdopen-2015-000189. eCollection 2016. |
| Label | URL |
|---|---|
| Related Info | View source |
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| ID | Title | Description |
|---|---|---|
| FG000 | Adalimumab | Participants who continued adalimumab treatment after completion of Study NCT00870467(M06-859) |
| FG001 | Non-Adalimumab | Participants who discontinued adalimumab treatment after completion of Study NCT00870467 (M06-859) |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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Modified Total Sharp Score (mTSS) is a method of assessing radiographs used in evaluation of inhibition of joint destruction of disease. Digitized X-rays of hands and feet were obtained, then scored in a blinded manner: for erosion (0 [no damage] to 5 [complete collapse or total destruction of joint]) and for joint space narrowing (0 [no damage] to 4 [complete luxation of joint]). Sum of scores was given as total mTSS (0 [normal] to 380 [maximal disease]). Large positive change in mTSS indicates disease progression; small positive/no change indicates slowing/halting of disease progression.
| Week 0 to Week 52 |
| Health Assessment Questionnaire Disability Index (HAQ-DI) | Participants assessed their ability to perform the following tasks: 1) dress/groom; 2) arise; 3) eat; 4) walk; 5) reach; 6) grip; 7) maintain hygiene; and 8) maintain daily activity. Participants assessed their ability to do these tasks over the past week by marking their response on a questionnaire. Possible responses/scores included the following: without any difficulty (0); with some difficulty (1); with much difficulty (2); and unable to do (3). Negative mean changes from baseline in the disability index of the HAQ-DI indicated improvement. | Weeks 0, 26, and 52 |
| Number of Participants With Adverse Events (AEs) | Adverse events (AEs) were collected from week 0 till the end of the study. Please see Adverse Event section below for more details. | Week 0 to Week 52 |
| Aomori |
| Japan |
| Site Reference ID/Investigator# 54516 | Chiba | Japan |
| Site Reference ID/Investigator# 54660 | Chiba | Japan |
| Site Reference ID/Investigator# 54683 | Chiba | Japan |
| Site Reference ID/Investigator# 54521 | Fukuoka | Japan |
| Site Reference ID/Investigator# 39854 | Gifu | Japan |
| Site Reference ID/Investigator# 54666 | Hamamatsu | Japan |
| Site Reference ID/Investigator# 54682 | Hiroshima | Japan |
| Site Reference ID/Investigator# 54669 | Hyōgo | Japan |
| Site Reference ID/Investigator# 54674 | Hyōgo | Japan |
| Site Reference ID/Investigator# 54653 | Ibaraki | Japan |
| Site Reference ID/Investigator# 54670 | Kagoshima | Japan |
| Site Reference ID/Investigator# 54692 | Kagoshima | Japan |
| Site Reference ID/Investigator# 54679 | Kawagoe | Japan |
| Site Reference ID/Investigator# 59580 | Kawagoe | Japan |
| Site Reference ID/Investigator# 54662 | Kawasaki | Japan |
| Site Reference ID/Investigator# 54693 | Kirishima | Japan |
| Site Reference ID/Investigator# 54671 | Kitakyushu | Japan |
| Site Reference ID/Investigator# 54643 | Kumamoto | Japan |
| Site Reference ID/Investigator# 59583 | Kyoto | Japan |
| Site Reference ID/Investigator# 59582 | Maebashi | Japan |
| Site Reference ID/Investigator# 39849 | Matsumoto | Japan |
| Site Reference ID/Investigator# 54520 | Matsuyama | Japan |
| Site Reference ID/Investigator# 54644 | Miyazaki | Japan |
| Site Reference ID/Investigator# 54645 | Morioka | Japan |
| Site Reference ID/Investigator# 54654 | Nagano | Japan |
| Site Reference ID/Investigator# 54656 | Nagaoka | Japan |
| Site Reference ID/Investigator# 63052 | Nagasaki | Japan |
| Site Reference ID/Investigator# 54667 | Nagoya | Japan |
| Site Reference ID/Investigator# 54673 | Nagoya | Japan |
| Site Reference ID/Investigator# 54649 | Nara | Japan |
| Site Reference ID/Investigator# 39844 | Niigata | Japan |
| Site Reference ID/Investigator# 39847 | Okayama | Japan |
| Site Reference ID/Investigator# 54681 | Okayama | Japan |
| Site Reference ID/Investigator# 39846 | Osaka | Japan |
| Site Reference ID/Investigator# 54518 | Osaka | Japan |
| Site Reference ID/Investigator# 54675 | Ōita | Japan |
| Site Reference ID/Investigator# 54646 | Rifu | Japan |
| Site Reference ID/Investigator# 54661 | Sagamihara, Kanagawa | Japan |
| Site Reference ID/Investigator# 54514 | Saitama | Japan |
| Site Reference ID/Investigator# 54689 | Saitama | Japan |
| Site Reference ID/Investigator# 25922 | Sapporo | Japan |
| Site Reference ID/Investigator# 39850 | Sapporo | Japan |
| Site Reference ID/Investigator# 54651 | Sapporo | Japan |
| Site Reference ID/Investigator# 54652 | Sapporo | Japan |
| Site Reference ID/Investigator# 54522 | Sasebo | Japan |
| Site Reference ID/Investigator# 54650 | Setouchi | Japan |
| Site Reference ID/Investigator# 39851 | Shimotsuke | Japan |
| Site Reference ID/Investigator# 39845 | Shizuoka | Japan |
| Site Reference ID/Investigator# 54517 | Shizuoka | Japan |
| Site Reference ID/Investigator# 59579 | Takamatsu | Japan |
| Site Reference ID/Investigator# 54655 | Takasaki | Japan |
| Site Reference ID/Investigator# 54519 | Tenri | Japan |
| Site Reference ID/Investigator# 54515 | Tokorozawa | Japan |
| Site Reference ID/Investigator# 39842 | Tokyo | Japan |
| Site Reference ID/Investigator# 39852 | Tokyo | Japan |
| Site Reference ID/Investigator# 39853 | Tokyo | Japan |
| Site Reference ID/Investigator# 54647 | Tokyo | Japan |
| Site Reference ID/Investigator# 54657 | Tokyo | Japan |
| Site Reference ID/Investigator# 54658 | Tokyo | Japan |
| Site Reference ID/Investigator# 54678 | Tokyo | Japan |
| Site Reference ID/Investigator# 54688 | Tokyo | Japan |
| Site Reference ID/Investigator# 59581 | Tokyo | Japan |
| Site Reference ID/Investigator# 54672 | Tomigusuku | Japan |
| Site Reference ID/Investigator# 54648 | Toyama | Japan |
| Site Reference ID/Investigator# 54691 | Toyama | Japan |
| Site Reference ID/Investigator# 54690 | Toyoake | Japan |
| Site Reference ID/Investigator# 54676 | Toyohashi | Japan |
| Site Reference ID/Investigator# 54668 | Tsu | Japan |
| Site Reference ID/Investigator# 39843 | Yokohama | Japan |
| Site Reference ID/Investigator# 54663 | Yokohama | Japan |
| Site Reference ID/Investigator# 54664 | Yokohama | Japan |
| Site Reference ID/Investigator# 54665 | Yokohama | Japan |
| Site Reference ID/Investigator# 54659 | Yotsukaidō | Japan |
| COMPLETED |
|
| NOT COMPLETED |
|
|
All participants registered
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Adalimumab | Participants who continued adalimumab treatment after completion of Study NCT00870467(M06-859) |
| BG001 | Non-Adalimumab | Participants who discontinued adalimumab treatment after completion of Study NCT00870467 (M06-859) |
| BG002 | Total | Total of all reporting groups |
| 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 |
| ||||||||||||||||
| Body weight | Mean | Standard Deviation | kg |
| |||||||||||||||
| Rheumatoid arthritis duration | Mean | Standard Deviation | years |
| |||||||||||||||
| Prior Disease Modifying Anti-Rheumatic Drug (except methotrexate) | Number | participants |
| ||||||||||||||||
| Concomitant Glucocorticoid Use | Number | participants |
| ||||||||||||||||
| Rheumatoid Factor | Number | participants |
| ||||||||||||||||
| Health Assessment Questionnaire Disability Index (HAQ-DI) | Participants assessed their ability to perform the following tasks: 1) dress/groom; 2) arise; 3) eat; 4) walk; 5) reach; 6) grip; 7) maintain hygiene; and 8) maintain daily activity. Participants assessed their ability to do these tasks over the past week by marking their response on a questionnaire. Possible responses/scores included the following: without any difficulty (0); with some difficulty (1); with much difficulty (2); and unable to do (3). | Mean | Standard Deviation | units on a scale |
| ||||||||||||||
| Disease Activity Score | The Disease Activity Score (DAS28) is a combined index used to measure disease activity in patients with rheumatoid arthritis. Calculation of the DAS28 score used the tender joint count (28 joints), swollen joint count (28 joints), patient's global assessment of disease activity, and the erythrocyte sedimentation rate (ESR). DAS 28 (ESR) scores range from 0 (no disease activity) to 9 (maximal disease activity). | Mean | Standard Deviation | units on a scale |
| ||||||||||||||
| Modified Total Sharp Score (mTSS) | Modified Total Sharp Score (mTSS) is a method of assessing radiographs, used in evaluation of inhibition of joint destruction of disease. Digitized X-rays of hands and feet were obtained, then scored in a blinded manner: for erosion (0 [no damage] to 5 [complete collapse or total destruction of joint]) and for joint space narrowing (0 [no damage] to 4 [complete luxation of joint]). Sum of scores was given as total mTSS (0 [normal] to 380 [maximal disease]). | Mean | Standard Deviation | units on a scale |
| ||||||||||||||
| Matrix Metalloprotease (MMP-3) | Matrix metalloprotease level in serum | Mean | Standard Deviation | ng/mL |
|
| 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 | Disease Activity Score (DAS28) | The Disease Activity Score (DAS28) is a combined index used to measure disease activity in participants with rheumatoid arthritis. Calculation of the DAS28 score used the tender joint count (28 joints), swollen joint count (28 joints), patient's global assessment of disease activity, and the erythrocyte sedimentation rate (ESR). DAS 28 (ESR) scores range from 0 (no disease activity) to 9 (maximal disease activity); decrease is indicative of improvement in disease activity. | All participants with post-baseline DAS28 data, using last-observation-carried forward (LOCF) imputation method. | Posted | Mean | Standard Deviation | units on a scale | Weeks 0, 26, and 52 |
|
|
|
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Matrix Metalloprotease-3 (MMP-3) | MMP-3 level in serum. Positive = >/= 121.0 ng/mL (male) and 59.7 ng/mL (female) | All participants with post-baseline MMP-3 data, using LOCF imputation method | Posted | Number | units on a scale | Weeks 0, 26, and 52 |
|
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Modified Total Sharp Score (mTSS) Change From Week 0 to Week 52 | Modified Total Sharp Score (mTSS) is a method of assessing radiographs used in evaluation of inhibition of joint destruction of disease. Digitized X-rays of hands and feet were obtained, then scored in a blinded manner: for erosion (0 [no damage] to 5 [complete collapse or total destruction of joint]) and for joint space narrowing (0 [no damage] to 4 [complete luxation of joint]). Sum of scores was given as total mTSS (0 [normal] to 380 [maximal disease]). Large positive change in mTSS indicates disease progression; small positive/no change indicates slowing/halting of disease progression. | All participants with post-baseline mTSS data, using LOCF imputation method | Posted | Mean | Standard Deviation | units on a scale | Week 0 to Week 52 |
|
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Health Assessment Questionnaire Disability Index (HAQ-DI) | Participants assessed their ability to perform the following tasks: 1) dress/groom; 2) arise; 3) eat; 4) walk; 5) reach; 6) grip; 7) maintain hygiene; and 8) maintain daily activity. Participants assessed their ability to do these tasks over the past week by marking their response on a questionnaire. Possible responses/scores included the following: without any difficulty (0); with some difficulty (1); with much difficulty (2); and unable to do (3). Negative mean changes from baseline in the disability index of the HAQ-DI indicated improvement. | All participants with post-baseline HAQ-DI data, using LOCF imputation method | Posted | Mean | Standard Deviation | units on a scale | Weeks 0, 26, and 52 |
|
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Number of Participants With Adverse Events (AEs) | Adverse events (AEs) were collected from week 0 till the end of the study. Please see Adverse Event section below for more details. | All participants registered | Posted | Number | participants | Week 0 to Week 52 |
|
|
Week 0 to Week 52
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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 | Adalimumab | Participants who continued adalimumab treatment after completion of Study NCT00870467(M06-859) | 5 | 106 | 46 | 106 | ||
| EG001 | Non-Adalimumab | Participants who discontinued adalimumab treatment after completion of Study NCT00870467 (M06-859) | 3 | 114 | 36 | 114 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Inguinal hernia | Gastrointestinal disorders | MedDRA/J Ver. 15.1 | Non-systematic Assessment |
| |
| Gastroenteritis | Infections and infestations | MedDRA 15.1 | Non-systematic Assessment |
| |
| Herpes zoster | Infections and infestations | MedDRA 15.1 | Non-systematic Assessment |
| |
| Pneumonia | Infections and infestations | MedDRA 15.1 | Non-systematic Assessment |
| |
| Pyelonephritis acute | Infections and infestations | MedDRA 15.1 | Non-systematic Assessment |
| |
| Sepsis | Infections and infestations | MedDRA 15.1 | Non-systematic Assessment |
| |
| Large intestine carcinoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 15.1 | Non-systematic Assessment |
| |
| Scar | Skin and subcutaneous tissue disorders | MedDRA 15.1 | Non-systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Cataract | Eye disorders | MedDRA/J Ver. 15.1 | Non-systematic Assessment |
| |
| Constipation | Gastrointestinal disorders | MedDRA 15.1 | Non-systematic Assessment |
| |
| Stomatitis | Gastrointestinal disorders | MedDRA 15.1 | Non-systematic Assessment |
| |
| Injection site reaction | General disorders | MedDRA 15.1 | Non-systematic Assessment |
| |
| Pyrexia | General disorders | MedDRA 15.1 | Non-systematic Assessment |
| |
| Liver disorder (enzyme elevation) | Hepatobiliary disorders | MedDRA 15.1 | Non-systematic Assessment |
| |
| Bronchitis | Infections and infestations | MedDRA 15.1 | Non-systematic Assessment |
| |
| Gastroenteritis | Infections and infestations | MedDRA 15.1 | Non-systematic Assessment |
| |
| Herpes zoster | Infections and infestations | MedDRA 15.1 | Non-systematic Assessment |
| |
| Nasopharyngitis | Infections and infestations | MedDRA 15.1 | Non-systematic Assessment |
| |
| Pharyngitis | Infections and infestations | MedDRA 15.1 | Non-systematic Assessment |
| |
| Pneumonia | Infections and infestations | MedDRA 15.1 | Non-systematic Assessment |
| |
| Oral herpes | Infections and infestations | MedDRA 15.1 | Non-systematic Assessment |
| |
| Fall | Injury, poisoning and procedural complications | MedDRA 15.1 | Non-systematic Assessment |
| |
| White blood cell count decreased | Investigations | MedDRA 15.1 | Non-systematic Assessment |
| |
| Hyperlipidaemia | Metabolism and nutrition disorders | MedDRA 15.1 | Non-systematic Assessment |
| |
| Headache | Nervous system disorders | MedDRA 15.1 | Non-systematic Assessment |
| |
| Upper respiratory tract inflammation | Respiratory, thoracic and mediastinal disorders | MedDRA 15.1 | Non-systematic Assessment |
| |
| Rash | Skin and subcutaneous tissue disorders | MedDRA 15.1 | Non-systematic Assessment |
| |
| Hypertension | Vascular disorders | MedDRA 15.1 | Non-systematic Assessment |
| |
| Angina pectoris | Cardiac disorders | MedDRA 15.1 | Non-systematic Assessment |
| |
| Conjunctivitis | Eye disorders | MedDRA 15.1 | Non-systematic Assessment |
| |
| Dry eye | Eye disorders | MedDRA 15.1 | Non-systematic Assessment |
| |
| Punctate keratitis | Eye disorders | MedDRA 15.1 | Non-systematic Assessment |
| |
| Xerophthalmia | Eye disorders | MedDRA 15.1 | Non-systematic Assessment |
| |
| Abdominal pain | Gastrointestinal disorders | MedDRA 15.1 | Non-systematic Assessment |
| |
| Abdominal pain upper | Gastrointestinal disorders | MedDRA 15.1 | Non-systematic Assessment |
| |
| Chelitis | Gastrointestinal disorders | MedDRA 15.1 | Non-systematic Assessment |
| |
| Dental caries | Gastrointestinal disorders | MedDRA 15.1 | Non-systematic Assessment |
| |
| Diarrhoea | Gastrointestinal disorders | MedDRA 15.1 | Non-systematic Assessment |
| |
| Dry mouth | Gastrointestinal disorders | MedDRA 15.1 | Non-systematic Assessment |
| |
| Gastric ulcer | Gastrointestinal disorders | MedDRA 15.1 | Non-systematic Assessment |
| |
| Toothache | Gastrointestinal disorders | MedDRA 15.1 | Non-systematic Assessment |
| |
| Vomiting | Gastrointestinal disorders | MedDRA 15.1 | Non-systematic Assessment |
| |
| Pancreatic enlargement | Gastrointestinal disorders | MedDRA 15.1 | Non-systematic Assessment |
| |
| Malaise | General disorders | MedDRA 15.1 | Non-systematic Assessment |
| |
| Hepatic function abnormal | Hepatobiliary disorders | MedDRA 15.1 | Non-systematic Assessment |
| |
| Hepatic steatosis | Hepatobiliary disorders | MedDRA 15.1 | Non-systematic Assessment |
| |
| Driug-induced liver injury | Hepatobiliary disorders | MedDRA 15.1 | Non-systematic Assessment |
| |
| Acute sinusitis | Infections and infestations | MedDRA 15.1 | Non-systematic Assessment |
| |
| Bronchopneumonia | Infections and infestations | MedDRA 15.1 | Non-systematic Assessment |
| |
| Cystitis | Infections and infestations | MedDRA 15.1 | Non-systematic Assessment |
| |
| Genital candidiasis | Infections and infestations | MedDRA 15.1 | Non-systematic Assessment |
| |
| Rhinitis | Infections and infestations | MedDRA 15.1 | Non-systematic Assessment |
| |
| Sinusitis | Infections and infestations | MedDRA 15.1 | Non-systematic Assessment |
| |
| Upper respiratory tract infection | Infections and infestations | MedDRA 15.1 | Non-systematic Assessment |
| |
| Pneumonia bacterial | Infections and infestations | MedDRA 15.1 | Non-systematic Assessment |
| |
| Bronchitis bacterial | Infections and infestations | MedDRA 15.1 | Non-systematic Assessment |
| |
| Ligament sprain | Injury, poisoning and procedural complications | MedDRA 15.1 | Non-systematic Assessment |
| |
| Excoriation | Injury, poisoning and procedural complications | MedDRA 15.1 | Non-systematic Assessment |
| |
| Contusion | Injury, poisoning and procedural complications | MedDRA/J Ver. 15.1 | Non-systematic Assessment |
| |
| Alanine aminotransferase increased | Investigations | MedDRA 15.1 | Non-systematic Assessment |
| |
| Aspartate aminotransferase increased | Investigations | MedDRA 15.1 | Non-systematic Assessment |
| |
| Liver function test abnormal | Investigations | MedDRA 15.1 | Non-systematic Assessment |
| |
| Diabetes mellitus | Metabolism and nutrition disorders | MedDRA 15.1 | Non-systematic Assessment |
| |
| Hypercholesterolaemia | Metabolism and nutrition disorders | MedDRA 15.1 | Non-systematic Assessment |
| |
| Bursitis | Musculoskeletal and connective tissue disorders | MedDRA 15.1 | Non-systematic Assessment |
| |
| Muscle spasms | Musculoskeletal and connective tissue disorders | MedDRA 15.1 | Non-systematic Assessment |
| |
| Osteoporosis | Musculoskeletal and connective tissue disorders | MedDRA 15.1 | Non-systematic Assessment |
| |
| Periarthritis | Musculoskeletal and connective tissue disorders | MedDRA 15.1 | Non-systematic Assessment |
| |
| Trigger finger | Musculoskeletal and connective tissue disorders | MedDRA 15.1 | Non-systematic Assessment |
| |
| Dizziness | Nervous system disorders | MedDRA 15.1 | Non-systematic Assessment |
| |
| Dysgeusia | Nervous system disorders | MedDRA 15.1 | Non-systematic Assessment |
| |
| Nephrolithiasis | Renal and urinary disorders | MedDRA 15.1 | Non-systematic Assessment |
| |
| Urinary retention | Renal and urinary disorders | MedDRA 15.1 | Non-systematic Assessment |
| |
| Breast discomfort | Reproductive system and breast disorders | MedDRA 15.1 | Non-systematic Assessment |
| |
| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA 15.1 | Non-systematic Assessment |
| |
| Interstitial lung disease | Respiratory, thoracic and mediastinal disorders | MedDRA 15.1 | Non-systematic Assessment |
| |
| Pleural fibrosis | Respiratory, thoracic and mediastinal disorders | MedDRA 15.1 | Non-systematic Assessment |
| |
| Pleurisy | Respiratory, thoracic and mediastinal disorders | MedDRA 15.1 | Non-systematic Assessment |
| |
| Pharyngeal erythema | Respiratory, thoracic and mediastinal disorders | MedDRA 15.1 | Non-systematic Assessment |
| |
| Dermatitis | Skin and subcutaneous tissue disorders | MedDRA 15.1 | Non-systematic Assessment |
| |
| Dermatitis contact | Skin and subcutaneous tissue disorders | MedDRA 15.1 | Non-systematic Assessment |
| |
| Eczema | Skin and subcutaneous tissue disorders | MedDRA 15.1 | Non-systematic Assessment |
| |
| Erythema | Skin and subcutaneous tissue disorders | MedDRA 15.1 | Non-systematic Assessment |
| |
| Pruritus | Skin and subcutaneous tissue disorders | MedDRA 15.1 | Non-systematic Assessment |
| |
| Rash generalized | Skin and subcutaneous tissue disorders | MedDRA 15.1 | Non-systematic Assessment |
| |
| Seborrheic dermatitis | Skin and subcutaneous tissue disorders | MedDRA 15.1 | Non-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.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Global Medical Services | AbbVie (prior sponsor, Abbott) | 800-633-9110 |
| ID | Term |
|---|---|
| D001172 | Arthritis, Rheumatoid |
| ID | Term |
|---|---|
| D001168 | Arthritis |
| D007592 | Joint Diseases |
| D009140 | Musculoskeletal Diseases |
| D012216 | Rheumatic Diseases |
| D003240 | Connective Tissue Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D001327 | Autoimmune Diseases |
| D007154 | Immune System Diseases |
Not provided
Not provided
| Male |
|
| No |
|
| No |
|
| Negative |
|
| Female |
|
| Week 52 |
|
| 0.004 |
| 95 |
| Superiority or Other |
| Week 52 | Wilcoxon Rank Sum | 0.006 | 95 | Superiority or Other |
|
|
|
|
|
|
|
|