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| ID | Type | Description | Link |
|---|---|---|---|
| 2014-003558-15 | EudraCT Number |
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This study is a Phase 2 randomized, double-blind, double-dummy, active- and placebo-controlled, parallel-group study designed to assess the safety, tolerability, efficacy, pharmacokinetics and immunogenicity of multiple doses of ABT-122 in participants with active PsA who are inadequately responding to MTX treatment.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Adalimumab | Active Comparator | Double-blind adalimumab 40 mg administered every other week (EOW) for 12 weeks |
|
| Placebo | Placebo Comparator | Double-blind placebo administered every week (EW) for 12 weeks |
|
| ABT-122 120 mg | Experimental | Double-blind ABT-122 120 mg administered EW for 12 weeks |
|
| ABT-122 240 mg | Experimental | Double-blind ABT-122 240 mg administered EW for 12 weeks |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| adalimumab | Biological |
|
| |
| ABT-122 |
| Measure | Description | Time Frame |
|---|---|---|
| American College of Rheumatology (ACR) 20 Response Rate at Week 12: ABT-122 Versus Placebo | Percentage of participants with an ACR20 response, defined as at least 20% improvement (compared to baseline values) in tender and swollen joint counts and at least 20% improvement in 3 of the remaining 5 core set measures (subject global assessment of pain, subject global assessment of disease activity, physician global assessment of disease activity, subject assessment of physical function and acute phase reactant high sensitivity C-reactive protein [hsCRP]). Estimates of the 95% confidence interval of the response rates for each treatment group were calculated using the Agresti-Coull method. | Week 12 |
| Measure | Description | Time Frame |
|---|---|---|
| ACR20 Response Rate at Week 12: ABT-122 Versus Adalimumab | Percentage of participants with an ACR20 response, defined as at least 20% improvement (compared to baseline values) in tender and swollen joint counts and at least 20% improvement in 3 of the remaining 5 core set measures (subject global assessment of pain, subject global assessment of disease activity, physician global assessment of disease activity, subject assessment of physical function and acute phase reactant hsCRP). Estimates of the 95% confidence interval of the response rates for each treatment group were calculated using the Agresti-Coull method. |
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Inclusion Criteria:
PsA diagnosis of at least 3 months duration prior to the date of first screening with ClASsification of Psoriatic ARthritis (CASPAR) confirmed diagnosis at Screening.
Have active psoriasis defined by at least 1 psoriasis lesion >= 2 cm diameter in areas other than the axilla or groin.
Have active arthritis defined by minimum disease activity criteria:
On a stable dose of methotrexate (MTX) defined as:
Exclusion Criteria:
Up to 30% (approximately 66 subjects) with prior exposure to a TNF inhibitor may be enrolled if the TNF inhibitor was not discontinued due to lack of efficacy or safety concerns. Subjects must be washed out for at least 5 half-lives of these drugs prior to the Baseline visit.
Subjects on prior adalimumab may not be enrolled in the study
Prior exposure to other non-TNF inhibitor biological disease-modifying antirheumatic drugs (DMARDs) will be permitted if the subject is washed out at least 5 half-lives of these drugs prior to the baseline visit.
Current treatment with traditional oral/intramuscular DMARDs, including conventional synthetic DMARDs (csDMARDs; except for concomitant treatment with sulfasalazine and/or hydroxychloroquine in addition to MTX). Oral DMARDs must be washed out for at least 5 half-lives of a drug apart from MTX prior to the Baseline visit.
a. Subject could have been exposed to prior Janus kinase (JAK) or phosphodiesterase type 4 (PDE4) inhibitors so long as they have been off therapy for at least 5 half-lives.
Stable prescribed dose of oral prednisone or prednisone equivalent > 10 mg/day within the 30 days of the Baseline visit.
Intra-articular or parenteral administration of corticosteroids in the preceding 4 weeks of the Baseline visit. Inhaled corticosteroids for stable medical conditions are allowed.
Laboratory values of the following at the Screening Visit:
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| Name | Affiliation | Role |
|---|---|---|
| Paul Peloso, MD | AbbVie | Study Director |
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| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 30376130 | Derived | Khatri A, Klunder B, Peloso PM, Othman AA. Exposure-response analyses demonstrate no evidence of interleukin 17A contribution to efficacy of ABT-122 in rheumatoid or psoriatic arthritis. Rheumatology (Oxford). 2019 Feb 1;58(2):352-360. doi: 10.1093/rheumatology/key312. | |
| 29855175 | Derived | Mease PJ, Genovese MC, Weinblatt ME, Peloso PM, Chen K, Othman AA, Li Y, Mansikka HT, Khatri A, Wishart N, Liu J. Phase II Study of ABT-122, a Tumor Necrosis Factor- and Interleukin-17A-Targeted Dual Variable Domain Immunoglobulin, in Patients With Psoriatic Arthritis With an Inadequate Response to Methotrexate. Arthritis Rheumatol. 2018 Nov;70(11):1778-1789. doi: 10.1002/art.40579. |
| Label | URL |
|---|---|
| Humira Prescribing info | View source |
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| ID | Title | Description |
|---|---|---|
| FG000 | Placebo EW | Double-blind placebo administered every week (EW) for 12 weeks |
| FG001 | Adalimumab 40 mg EOW | Double-blind adalimumab 40 mg administered every other week (EOW) for 12 weeks |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| Biological |
|
|
| Week 12 |
| ACR50 Response Rate at Week 12 | Percentage of participants with an ACR50 response, defined as at least 50% improvement (compared to baseline values) in tender and swollen joint counts and at least 50% improvement in 3 of the remaining 5 core set measures (subject global assessment of pain, subject global assessment of disease activity, physician global assessment of disease activity, subject assessment of physical function and acute phase reactant hsCRP. Estimates of the 95% confidence interval of the response rates for each treatment group were calculated using the Agresti-Coull method. | Week 12 |
| ACR70 Response Rate at Week 12 | Percentage of participants with an ACR70 response, defined as at least 70% improvement (compared to baseline values) in tender and swollen joint counts and at least 70% improvement in 3 of the remaining 5 core set measures (subject global assessment of pain, subject global assessment of disease activity, physician global assessment of disease activity, subject assessment of physical function and acute phase reactant hsCRP. Estimates of the 95% confidence interval of the response rates for each treatment group were calculated using the Agresti-Coull method. | Week 12 |
| ACRn at Week 12 | ACR measures percentage improvements in tender and swollen joint counts, patient assessments of pain, global disease activity and physical function, physician global assessment of disease activity and acute phase reactant. ACRn is a continuous variable based on the ACR criteria. Improvement from baseline in a component of the ACR composite variable was computed as the difference between the baseline value and the value at a given post-baseline visit. A positive value for improvement from baseline for an individual component indicates lesser severity of disease. The 95% confidence interval for mean is constructed using T-statistic with significance level alpha=5%. | At Week 12 |
| Change From Baseline in Disease Activity Score 28 (DAS28[hsCRP]) at Week 12 | The DAS28 (hsCRP) is a validated index of rheumatoid arthritis disease activity. Twenty-eight tender joint counts, 28 swollen joint counts, hsCRP, and general health are included in the DAS28 (hsCRP) score. Scores range from 0 to 10, with higher scores indicating more disease activity. | Baseline, Week 12 |
| Change From Baseline in Psoriatic Arthritis Disease Activity Score (PASDAS) at Week 12 | PASDAS is a continuous compound disease activity state score determined by the combined values of tender or swollen joint counts, participant-reported outcome and hsCRP lab test. The PASDAS is unitless, with a typical score range between 0 and 10. Smaller values on PASDAS indicate a better condition; a negative change from baseline indicates improvement. | Baseline, Week 12 |
| Change From Baseline in Psoriasis Target Lesion Score at Week 12 | Target lesion score for psoriasis in participants with psoriatic arthritis is calculated by adding the scores of plaque erythema, scaling and thickness. Scores range from 0 (no erythema or evidence of plaque thickness) to 10 (severe erythema and evidence of plaque thickness). | Baseline, Week 12 |
| FG002 | ABT-122 120 mg EW | Double-blind ABT-122 120 mg administered EW for 12 weeks |
| FG003 | ABT-122 240 mg EW | Double-blind ABT-122 240 mg administered EW for 12 weeks |
| COMPLETED |
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| NOT COMPLETED |
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Full Analysis Set: randomized participants who received at least 1 dose of study medication.
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| ID | Title | Description |
|---|---|---|
| BG000 | Placebo EW | Double-blind placebo administered EW for 12 weeks |
| BG001 | Adalimumab 40 mg EOW | Double-blind adalimumab 40 mg administered EOW for 12 weeks |
| BG002 | ABT-122 120 mg EW | Double-blind ABT-122 120 mg administered EW for 12 weeks |
| BG003 | ABT-122 240 mg EW | Double-blind ABT-122 240 mg administered EW for 12 weeks |
| BG004 | 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 |
|
| 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 | American College of Rheumatology (ACR) 20 Response Rate at Week 12: ABT-122 Versus Placebo | Percentage of participants with an ACR20 response, defined as at least 20% improvement (compared to baseline values) in tender and swollen joint counts and at least 20% improvement in 3 of the remaining 5 core set measures (subject global assessment of pain, subject global assessment of disease activity, physician global assessment of disease activity, subject assessment of physical function and acute phase reactant high sensitivity C-reactive protein [hsCRP]). Estimates of the 95% confidence interval of the response rates for each treatment group were calculated using the Agresti-Coull method. | Full Analysis Set: all randomized participants who received at least 1 dose of study drug. Non-responder imputation (NRI): missing responses are imputed as non-responders. | Posted | Number | 95% Confidence Interval | percentage of participants | Week 12 |
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| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | ACR20 Response Rate at Week 12: ABT-122 Versus Adalimumab | Percentage of participants with an ACR20 response, defined as at least 20% improvement (compared to baseline values) in tender and swollen joint counts and at least 20% improvement in 3 of the remaining 5 core set measures (subject global assessment of pain, subject global assessment of disease activity, physician global assessment of disease activity, subject assessment of physical function and acute phase reactant hsCRP). Estimates of the 95% confidence interval of the response rates for each treatment group were calculated using the Agresti-Coull method. | Full Analysis Set: all randomized participants who received at least 1 dose of study drug. NRI: missing responses are imputed as non-responders. | Posted | Number | 95% Confidence Interval | percentage of participants | Week 12 |
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | ACR50 Response Rate at Week 12 | Percentage of participants with an ACR50 response, defined as at least 50% improvement (compared to baseline values) in tender and swollen joint counts and at least 50% improvement in 3 of the remaining 5 core set measures (subject global assessment of pain, subject global assessment of disease activity, physician global assessment of disease activity, subject assessment of physical function and acute phase reactant hsCRP. Estimates of the 95% confidence interval of the response rates for each treatment group were calculated using the Agresti-Coull method. | Full Analysis Set: all randomized participants who received at least 1 dose of study drug. NRI: missing responses are imputed as non-responders. | Posted | Number | 95% Confidence Interval | percentage of participants | Week 12 |
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | ACR70 Response Rate at Week 12 | Percentage of participants with an ACR70 response, defined as at least 70% improvement (compared to baseline values) in tender and swollen joint counts and at least 70% improvement in 3 of the remaining 5 core set measures (subject global assessment of pain, subject global assessment of disease activity, physician global assessment of disease activity, subject assessment of physical function and acute phase reactant hsCRP. Estimates of the 95% confidence interval of the response rates for each treatment group were calculated using the Agresti-Coull method. | Full Analysis Set: all randomized participants who received at least 1 dose of study drug. NRI: missing responses are imputed as non-responders. | Posted | Number | 95% Confidence Interval | percentage of participants | Week 12 |
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | ACRn at Week 12 | ACR measures percentage improvements in tender and swollen joint counts, patient assessments of pain, global disease activity and physical function, physician global assessment of disease activity and acute phase reactant. ACRn is a continuous variable based on the ACR criteria. Improvement from baseline in a component of the ACR composite variable was computed as the difference between the baseline value and the value at a given post-baseline visit. A positive value for improvement from baseline for an individual component indicates lesser severity of disease. The 95% confidence interval for mean is constructed using T-statistic with significance level alpha=5%. | Full Analysis Set: all randomized participants who received at least 1 dose of study drug. Last observation carried forward (LOCF): missing responses are imputed by calculation based on the last non-missing post-baseline component values. | Posted | Mean | 95% Confidence Interval | percentage improvement | At Week 12 |
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Change From Baseline in Disease Activity Score 28 (DAS28[hsCRP]) at Week 12 | The DAS28 (hsCRP) is a validated index of rheumatoid arthritis disease activity. Twenty-eight tender joint counts, 28 swollen joint counts, hsCRP, and general health are included in the DAS28 (hsCRP) score. Scores range from 0 to 10, with higher scores indicating more disease activity. | Full Analysis Set: all randomized participants who received at least 1 dose of study drug. LOCF: missing responses are imputed by calculation based on the last non-missing post-baseline component values. | Posted | Least Squares Mean | 95% Confidence Interval | units on a scale | Baseline, Week 12 |
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Change From Baseline in Psoriatic Arthritis Disease Activity Score (PASDAS) at Week 12 | PASDAS is a continuous compound disease activity state score determined by the combined values of tender or swollen joint counts, participant-reported outcome and hsCRP lab test. The PASDAS is unitless, with a typical score range between 0 and 10. Smaller values on PASDAS indicate a better condition; a negative change from baseline indicates improvement. | Full Analysis Set: all randomized participants who received at least 1 dose of study drug. LOCF: missing responses are imputed by calculation based on the last non-missing post-baseline component values. | Posted | Least Squares Mean | 95% Confidence Interval | units on a scale | Baseline, Week 12 |
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| Secondary | Change From Baseline in Psoriasis Target Lesion Score at Week 12 | Target lesion score for psoriasis in participants with psoriatic arthritis is calculated by adding the scores of plaque erythema, scaling and thickness. Scores range from 0 (no erythema or evidence of plaque thickness) to 10 (severe erythema and evidence of plaque thickness). | Full Analysis Set: all randomized participants who received at least 1 dose of study drug. LOCF: missing responses are imputed by calculation based on the last non-missing post-baseline component values. | Posted | Least Squares Mean | 95% Confidence Interval | units on a scale | Baseline, Week 12 |
|
Treatment-emergent adverse events (TEAEs) were collected from first dose of study drug until 70 days after the last dose of study drug (up to 21 weeks); Serious adverse events (AEs) were collected from the time informed consent was obtained (25.5 weeks).
A TEAE is defined as any AE with onset or worsening reported by a participant from the time that the first dose of adalimumab or ABT-122 is administered until 5 half-lives (70 days) have elapsed following discontinuation of adalimumab or ABT-122 administration. TEAEs were collected whether elicited or spontaneously reported by the participant.
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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 | Placebo EW | Double-blind placebo administered EW for 12 weeks | 1 | 24 | 10 | 24 | ||
| EG001 | Adalimumab 40 mg EOW | Double-blind adalimumab 40 mg administered EOW for 12 weeks | 0 | 72 | 39 | 72 | ||
| EG002 | ABT-122 120 mg EW | Double-blind ABT-122 120 mg administered EW for 12 weeks | 0 | 71 | 33 | 71 | ||
| EG003 | ABT-122 240 mg EW | Double-blind ABT-122 240 mg administered EW for 12 weeks | 1 | 73 | 33 | 73 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| ROAD TRAFFIC ACCIDENT | Injury, poisoning and procedural complications | MedDRA version 19.1 | Systematic Assessment |
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| SKIN ABRASION | Injury, poisoning and procedural complications | MedDRA version 19.1 | Systematic Assessment |
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| UPPER LIMB FRACTURE | Injury, poisoning and procedural complications | MedDRA version 19.1 | Systematic Assessment |
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| HEART RATE DECREASED | Investigations | MedDRA version 19.1 | Systematic Assessment |
| |
| SYNCOPE | Nervous system disorders | MedDRA version 19.1 | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| GRANULOCYTOPENIA | Blood and lymphatic system disorders | MedDRA version 19.1 | Systematic Assessment |
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| LEUKOPENIA | Blood and lymphatic system disorders | MedDRA version 19.1 | Systematic Assessment |
| |
| LYMPHADENOPATHY | Blood and lymphatic system disorders | MedDRA version 19.1 | Systematic Assessment |
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| LYMPHOCYTOSIS | Blood and lymphatic system disorders | MedDRA version 19.1 | Systematic Assessment |
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| LYMPHOPENIA | Blood and lymphatic system disorders | MedDRA version 19.1 | Systematic Assessment |
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| NEUTROPENIA | Blood and lymphatic system disorders | MedDRA version 19.1 | Systematic Assessment |
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| PALPITATIONS | Cardiac disorders | MedDRA version 19.1 | Systematic Assessment |
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| SINUS TACHYCARDIA | Cardiac disorders | MedDRA version 19.1 | Systematic Assessment |
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| HYDROCELE | Congenital, familial and genetic disorders | MedDRA version 19.1 | Systematic Assessment |
| |
| VERTIGO | Ear and labyrinth disorders | MedDRA version 19.1 | Systematic Assessment |
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| BLEPHARITIS | Eye disorders | MedDRA version 19.1 | Systematic Assessment |
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| ERYTHEMA OF EYELID | Eye disorders | MedDRA version 19.1 | Systematic Assessment |
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| MYOPIA | Eye disorders | MedDRA version 19.1 | Systematic Assessment |
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| RETINAL VASCULAR DISORDER | Eye disorders | MedDRA version 19.1 | Systematic Assessment |
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| ABDOMINAL PAIN | Gastrointestinal disorders | MedDRA version 19.1 | Systematic Assessment |
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| DIARRHOEA | Gastrointestinal disorders | MedDRA version 19.1 | Systematic Assessment |
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| DYSPEPSIA | Gastrointestinal disorders | MedDRA version 19.1 | Systematic Assessment |
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| FOOD POISONING | Gastrointestinal disorders | MedDRA version 19.1 | Systematic Assessment |
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| GASTROOESOPHAGEAL REFLUX DISEASE | Gastrointestinal disorders | MedDRA version 19.1 | Systematic Assessment |
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| HAEMATOCHEZIA | Gastrointestinal disorders | MedDRA version 19.1 | Systematic Assessment |
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| INGUINAL HERNIA | Gastrointestinal disorders | MedDRA version 19.1 | Systematic Assessment |
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| NAUSEA | Gastrointestinal disorders | MedDRA version 19.1 | Systematic Assessment |
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| ORAL MUCOSA EROSION | Gastrointestinal disorders | MedDRA version 19.1 | Systematic Assessment |
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| STOMATITIS | Gastrointestinal disorders | MedDRA version 19.1 | Systematic Assessment |
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| TOOTHACHE | Gastrointestinal disorders | MedDRA version 19.1 | Systematic Assessment |
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| VOMITING | Gastrointestinal disorders | MedDRA version 19.1 | Systematic Assessment |
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| FATIGUE | General disorders | MedDRA version 19.1 | Systematic Assessment |
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| GAIT DISTURBANCE | General disorders | MedDRA version 19.1 | Systematic Assessment |
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| INFLUENZA LIKE ILLNESS | General disorders | MedDRA version 19.1 | Systematic Assessment |
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| INJECTION SITE BRUISING | General disorders | MedDRA version 19.1 | Systematic Assessment |
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| INJECTION SITE ERYTHEMA | General disorders | MedDRA version 19.1 | Systematic Assessment |
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| INJECTION SITE HAEMATOMA | General disorders | MedDRA version 19.1 | Systematic Assessment |
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| INJECTION SITE INDURATION | General disorders | MedDRA version 19.1 | Systematic Assessment |
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| INJECTION SITE OEDEMA | General disorders | MedDRA version 19.1 | Systematic Assessment |
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| INJECTION SITE PAPULE | General disorders | MedDRA version 19.1 | Systematic Assessment |
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| INJECTION SITE PRURITUS | General disorders | MedDRA version 19.1 | Systematic Assessment |
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| PERIPHERAL SWELLING | General disorders | MedDRA version 19.1 | Systematic Assessment |
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| VESSEL PUNCTURE SITE PHLEBITIS | General disorders | MedDRA version 19.1 | Systematic Assessment |
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| BILE DUCT OBSTRUCTION | Hepatobiliary disorders | MedDRA version 19.1 | Systematic Assessment |
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| HYPERBILIRUBINAEMIA | Hepatobiliary disorders | MedDRA version 19.1 | Systematic Assessment |
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| HYPERTRANSAMINASAEMIA | Hepatobiliary disorders | MedDRA version 19.1 | Systematic Assessment |
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| ACUTE SINUSITIS | Infections and infestations | MedDRA version 19.1 | Systematic Assessment |
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| BRONCHITIS | Infections and infestations | MedDRA version 19.1 | Systematic Assessment |
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| CONJUNCTIVITIS | Infections and infestations | MedDRA version 19.1 | Systematic Assessment |
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| FOLLICULITIS | Infections and infestations | MedDRA version 19.1 | Systematic Assessment |
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| FURUNCLE | Infections and infestations | MedDRA version 19.1 | Systematic Assessment |
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| GASTROENTERITIS | Infections and infestations | MedDRA version 19.1 | Systematic Assessment |
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| GASTROENTERITIS VIRAL | Infections and infestations | MedDRA version 19.1 | Systematic Assessment |
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| HORDEOLUM | Infections and infestations | MedDRA version 19.1 | Systematic Assessment |
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| INFLUENZA | Infections and infestations | MedDRA version 19.1 | Systematic Assessment |
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| LARYNGITIS | Infections and infestations | MedDRA version 19.1 | Systematic Assessment |
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| NASOPHARYNGITIS | Infections and infestations | MedDRA version 19.1 | Systematic Assessment |
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| ORAL CANDIDIASIS | Infections and infestations | MedDRA version 19.1 | Systematic Assessment |
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| ORAL HERPES | Infections and infestations | MedDRA version 19.1 | Systematic Assessment |
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| PARONYCHIA | Infections and infestations | MedDRA version 19.1 | Systematic Assessment |
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| PHARYNGITIS | Infections and infestations | MedDRA version 19.1 | Systematic Assessment |
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| PNEUMONIA | Infections and infestations | MedDRA version 19.1 | Systematic Assessment |
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| RHINITIS | Infections and infestations | MedDRA version 19.1 | Systematic Assessment |
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| SINUSITIS | Infections and infestations | MedDRA version 19.1 | Systematic Assessment |
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| SUBCUTANEOUS ABSCESS | Infections and infestations | MedDRA version 19.1 | Systematic Assessment |
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| UPPER RESPIRATORY TRACT INFECTION | Infections and infestations | MedDRA version 19.1 | Systematic Assessment |
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| URINARY TRACT INFECTION | Infections and infestations | MedDRA version 19.1 | Systematic Assessment |
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| URINARY TRACT INFECTION BACTERIAL | Infections and infestations | MedDRA version 19.1 | Systematic Assessment |
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| VIRAL PHARYNGITIS | Infections and infestations | MedDRA version 19.1 | Systematic Assessment |
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| VIRAL UPPER RESPIRATORY TRACT INFECTION | Infections and infestations | MedDRA version 19.1 | Systematic Assessment |
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| ANIMAL SCRATCH | Injury, poisoning and procedural complications | MedDRA version 19.1 | Systematic Assessment |
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| CONTUSION | Injury, poisoning and procedural complications | MedDRA version 19.1 | Systematic Assessment |
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| FALL | Injury, poisoning and procedural complications | MedDRA version 19.1 | Systematic Assessment |
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| FOOT FRACTURE | Injury, poisoning and procedural complications | MedDRA version 19.1 | Systematic Assessment |
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| INJURY | Injury, poisoning and procedural complications | MedDRA version 19.1 | Systematic Assessment |
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| LIGAMENT RUPTURE | Injury, poisoning and procedural complications | MedDRA version 19.1 | Systematic Assessment |
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| ROAD TRAFFIC ACCIDENT | Injury, poisoning and procedural complications | MedDRA version 19.1 | Systematic Assessment |
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| SPINAL COMPRESSION FRACTURE | Injury, poisoning and procedural complications | MedDRA version 19.1 | Systematic Assessment |
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| SPLINTER | Injury, poisoning and procedural complications | MedDRA version 19.1 | Systematic Assessment |
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| ALANINE AMINOTRANSFERASE INCREASED | Investigations | MedDRA version 19.1 | Systematic Assessment |
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| ASPARTATE AMINOTRANSFERASE INCREASED | Investigations | MedDRA version 19.1 | Systematic Assessment |
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| BLOOD CALCIUM INCREASED | Investigations | MedDRA version 19.1 | Systematic Assessment |
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| BLOOD CHOLESTEROL INCREASED | Investigations | MedDRA version 19.1 | Systematic Assessment |
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| BLOOD CREATININE INCREASED | Investigations | MedDRA version 19.1 | Systematic Assessment |
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| BLOOD PRESSURE INCREASED | Investigations | MedDRA version 19.1 | Systematic Assessment |
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| BLOOD TRIGLYCERIDES INCREASED | Investigations | MedDRA version 19.1 | Systematic Assessment |
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| BLOOD URIC ACID INCREASED | Investigations | MedDRA version 19.1 | Systematic Assessment |
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| BODY TEMPERATURE INCREASED | Investigations | MedDRA version 19.1 | Systematic Assessment |
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| CRYSTAL URINE PRESENT | Investigations | MedDRA version 19.1 | Systematic Assessment |
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| HAEMOGLOBIN INCREASED | Investigations | MedDRA version 19.1 | Systematic Assessment |
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| LYMPHOCYTE COUNT DECREASED | Investigations | MedDRA version 19.1 | Systematic Assessment |
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| MONOCYTE COUNT INCREASED | Investigations | MedDRA version 19.1 | Systematic Assessment |
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| NEUTROPHIL COUNT DECREASED | Investigations | MedDRA version 19.1 | Systematic Assessment |
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| TRANSAMINASES ABNORMAL | Investigations | MedDRA version 19.1 | Systematic Assessment |
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| TRANSAMINASES INCREASED | Investigations | MedDRA version 19.1 | Systematic Assessment |
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| URINE OUTPUT DECREASED | Investigations | MedDRA version 19.1 | Systematic Assessment |
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| WEIGHT INCREASED | Investigations | MedDRA version 19.1 | Systematic Assessment |
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| WHITE BLOOD CELL COUNT DECREASED | Investigations | MedDRA version 19.1 | Systematic Assessment |
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| DIABETES MELLITUS | Metabolism and nutrition disorders | MedDRA version 19.1 | Systematic Assessment |
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| DYSLIPIDAEMIA | Metabolism and nutrition disorders | MedDRA version 19.1 | Systematic Assessment |
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| HYPERCHOLESTEROLAEMIA | Metabolism and nutrition disorders | MedDRA version 19.1 | Systematic Assessment |
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| HYPERLIPIDAEMIA | Metabolism and nutrition disorders | MedDRA version 19.1 | Systematic Assessment |
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| HYPERTRIGLYCERIDAEMIA | Metabolism and nutrition disorders | MedDRA version 19.1 | Systematic Assessment |
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| HYPERURICAEMIA | Metabolism and nutrition disorders | MedDRA version 19.1 | Systematic Assessment |
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| HYPOGLYCAEMIA | Metabolism and nutrition disorders | MedDRA version 19.1 | Systematic Assessment |
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| BACK PAIN | Musculoskeletal and connective tissue disorders | MedDRA version 19.1 | Systematic Assessment |
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| INTERVERTEBRAL DISC PROTRUSION | Musculoskeletal and connective tissue disorders | MedDRA version 19.1 | Systematic Assessment |
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| MYALGIA | Musculoskeletal and connective tissue disorders | MedDRA version 19.1 | Systematic Assessment |
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| OSTEOARTHRITIS | Musculoskeletal and connective tissue disorders | MedDRA version 19.1 | Systematic Assessment |
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| OSTEOPOROSIS | Musculoskeletal and connective tissue disorders | MedDRA version 19.1 | Systematic Assessment |
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| PSORIATIC ARTHROPATHY | Musculoskeletal and connective tissue disorders | MedDRA version 19.1 | Systematic Assessment |
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| ROTATOR CUFF SYNDROME | Musculoskeletal and connective tissue disorders | MedDRA version 19.1 | Systematic Assessment |
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| SPINAL PAIN | Musculoskeletal and connective tissue disorders | MedDRA version 19.1 | Systematic Assessment |
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| HEADACHE | Nervous system disorders | MedDRA version 19.1 | Systematic Assessment |
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| NEUROPATHY PERIPHERAL | Nervous system disorders | MedDRA version 19.1 | Systematic Assessment |
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| SOMNOLENCE | Nervous system disorders | MedDRA version 19.1 | Systematic Assessment |
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| ANXIETY | Psychiatric disorders | MedDRA version 19.1 | Systematic Assessment |
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| DEPRESSION | Psychiatric disorders | MedDRA version 19.1 | Systematic Assessment |
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| INSOMNIA | Psychiatric disorders | MedDRA version 19.1 | Systematic Assessment |
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| STRESS | Psychiatric disorders | MedDRA version 19.1 | Systematic Assessment |
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| CRYSTALLURIA | Renal and urinary disorders | MedDRA version 19.1 | Systematic Assessment |
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| MICTURITION URGENCY | Renal and urinary disorders | MedDRA version 19.1 | Systematic Assessment |
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| POLLAKIURIA | Renal and urinary disorders | MedDRA version 19.1 | Systematic Assessment |
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| PROTEINURIA | Renal and urinary disorders | MedDRA version 19.1 | Systematic Assessment |
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| CATARRH | Respiratory, thoracic and mediastinal disorders | MedDRA version 19.1 | Systematic Assessment |
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| COUGH | Respiratory, thoracic and mediastinal disorders | MedDRA version 19.1 | Systematic Assessment |
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| DYSPNOEA | Respiratory, thoracic and mediastinal disorders | MedDRA version 19.1 | Systematic Assessment |
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| OROPHARYNGEAL PAIN | Respiratory, thoracic and mediastinal disorders | MedDRA version 19.1 | Systematic Assessment |
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| RHINITIS ALLERGIC | Respiratory, thoracic and mediastinal disorders | MedDRA version 19.1 | Systematic Assessment |
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| SINUS PAIN | Respiratory, thoracic and mediastinal disorders | MedDRA version 19.1 | Systematic Assessment |
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| THROAT IRRITATION | Respiratory, thoracic and mediastinal disorders | MedDRA version 19.1 | Systematic Assessment |
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| ACNE | Skin and subcutaneous tissue disorders | MedDRA version 19.1 | Systematic Assessment |
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| DERMATITIS ALLERGIC | Skin and subcutaneous tissue disorders | MedDRA version 19.1 | Systematic Assessment |
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| ERYTHEMA | Skin and subcutaneous tissue disorders | MedDRA version 19.1 | Systematic Assessment |
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| PRURITUS | Skin and subcutaneous tissue disorders | MedDRA version 19.1 | Systematic Assessment |
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| PSORIASIS | Skin and subcutaneous tissue disorders | MedDRA version 19.1 | Systematic Assessment |
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| RASH | Skin and subcutaneous tissue disorders | MedDRA version 19.1 | Systematic Assessment |
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| RASH ERYTHEMATOUS | Skin and subcutaneous tissue disorders | MedDRA version 19.1 | Systematic Assessment |
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| ECONOMIC PROBLEM | Social circumstances | MedDRA version 19.1 | Systematic Assessment |
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| HYPERTENSION | Vascular disorders | MedDRA version 19.1 | Systematic Assessment |
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| PHLEBITIS | Vascular disorders | MedDRA version 19.1 | Systematic Assessment |
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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 | 800-633-9110 |
| ID | Term |
|---|---|
| D015535 | Arthritis, Psoriatic |
| ID | Term |
|---|---|
| D025242 | Spondylarthropathies |
| D025241 | Spondylarthritis |
| D013166 | Spondylitis |
| D013122 | Spinal Diseases |
| D001847 | Bone Diseases |
| D009140 | Musculoskeletal Diseases |
| D001168 | Arthritis |
| D007592 | Joint Diseases |
| D011565 | Psoriasis |
| D017444 | Skin Diseases, Papulosquamous |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| D000068879 | Adalimumab |
| C000625317 | ABT-122 |
| 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
| Male |
|
| Fisher Exact |
| <0.001 |
P-value is calculated by one-sided Fisher's exact test to test whether ABT-122 treatment group is superior to placebo group. The a priori statistical significance threshold is P = 0.025. |
| response rate difference |
| 50.3 |
| 2-Sided |
| 95 |
| 28.1 |
| 67.4 |
| Superiority |
| Units | Counts |
|---|---|
| Participants |
|
|
|
| ABT-122 240 mg EW |
Double-blind ABT-122 240 mg administered EW for 12 weeks |
|
|
|
| ABT-122 240 mg EW |
Double-blind ABT-122 240 mg administered EW for 12 weeks |
|
|
|
Double-blind ABT-122 120 mg administered EW for 12 weeks
| OG003 | ABT-122 240 mg EW | Double-blind ABT-122 240 mg administered EW for 12 weeks |
|
|
|
Double-blind ABT-122 240 mg administered EW for 12 weeks
|
|
|
Double-blind ABT-122 240 mg administered EW for 12 weeks |
|
|
|
|
|
|