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| ID | Type | Description | Link |
|---|---|---|---|
| CNTO148SPD4001 | Other Identifier | Johnson & Johnson Private Limited |
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The purpose of this study is to assess the safety of subcutaneous (SC) golimumab in participants with active Ankylosing Spondylitis (AS) or Psoriatic Arthritis (PsA) over 24 weeks.
This post-marketing study will evaluate safety and efficacy profile of golimumab (a fully human anti-Tumour Necrosis Factor alpha [TNF-alpha] monoclonal antibodies [mAb], administered subcutaneously) in a real-world in Indian participants with active spondyloarthropathy of ankylosing spondylitis (AS) or psoriatic arthritis (PsA). AS is a chronic inflammatory disease of unknown etiology that involves the sacroiliac joints, axial skeleton, entheses, and peripheral joints. PsA is a chronic, inflammatory, usually rheumatoid factor negative arthritis that is associated with psoriasis. Golimumab binds with high affinity to human TNF-alpha and inhibits TNF-alpha bioactivity, TNF-alpha-mediated cell cytotoxicity and TNF-alpha mediated endothelial cell activation. Golimumab also induces activation of complement-mediated cell lysis and reduces the development of arthritis. Study evaluation includes efficacy (efficacy parameters for AS and PsA) and safety. Participant's safety will be monitored throughout the study. The total duration of study will be approximately 24 weeks.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Golimumab | Experimental | Participants will receive golimumab 50 milligram (mg) subcutaneous (SC) injection at Week 0 and every 4 weeks (q4w) thereafter through Week 24. Concomitant medications may be allowed on a case by case basis as per the physician's judgement. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Golimumab | Drug | Participants will receive golimumab 50 mg SC injections at Week 0 and q4w thereafter through Week 24. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants With Treatment-emergent Adverse Events (TEAEs) | An adverse event (AE) is any untoward medical occurrence in a clinical study participant administered a medicinal (investigational or non-investigational) product which does not necessarily have a causal relationship with the treatment. An AE can therefore be any unfavorable and unintended sign (including an abnormal finding), symptom, or disease temporally associated with the use of a medicinal product, whether or not related to that medicinal product. Any AE that occurred at or after the initial administration of study drug through the day of last dose plus 8 weeks was considered to be TEAE. | Up to Week 32 |
| Number of Participants With Treatment Emergent Serious Adverse Events (SAEs) | An adverse event (AE) is any untoward medical occurrence in a clinical study participant administered a medicinal (investigational or non-investigational) product which does not necessarily have a causal relationship with the treatment. An AE can therefore be any unfavorable and unintended sign (including an abnormal finding), symptom, or disease temporally associated with the use of a medicinal product, whether or not related to that medicinal product. SAE was any untoward medical occurrence that at any dose may result in death, is life-threatening, requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect, is a suspected transmission of any infectious agent via a medicinal product. Any AE that occurred at or after the initial administration of study drug through the day of last dose plus 8 weeks was considered to be TEAE. | Up to Week 32 |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Ankylosing Spondylitis (AS) Participants With at Least 20 Percent (%) Improvement in the Assessment of SpondyloArthritis International Society (ASAS20) Criteria at Week 14 | ASAS 20 response criteria was defined as an improvement from baseline of greater than (>)20% and >1 unit in at least 3 of following 4 ASAS domains on scale of 0-10 units and no worsening from baseline of >20% and >1 unit in the remaining ASAS domain on a scale of 0-10 units. The 4 ASAS domains were as follows (0-10 units numerical rating scale [NRS]): Patient's global assessment (PGA) of disease:0=not active spondylitis, 10=very active spondylitis; total and night Spinal pain: 0=no pain, 10=most severe pain; bath ankylosing spondylitis functional index (BASFI, self-assessment of participant's degree of mobility and functional ability represented as mean of 10 questions [8 of which relate to participant's functional anatomy and 2 relate to participant's ability to cope with everyday life): 0=easy, 10=impossible; and bath ankylosing spondylitis disease activity index (BASDAI, self-assessment survey of 6 questions for participant's disability due to AS): 0=none, 10=very severe).](streamdown:incomplete-link) |
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Inclusion Criteria:
For participants with Ankylosing Spondylitis (AS):
For participants with Psoriatic Arthritis (PsA):
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Johnson & Johnson Private Limited Clinical Trial | Johnson & Johnson Private Limited | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| ChanRe Rheumatology And Immunology Center And Research | Bangalore | 560079 | India | |||
| Apollo Hospitals |
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| ID | Title | Description |
|---|---|---|
| FG000 | Golimumab (Simponi) | Participants with active spondyloarthropathy of AS or PsA received golimumab 50 milligrams (mg) subcutaneous (SC) injection at Week 0 and every 4 weeks (q4w) thereafter through Week 24. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Jul 2, 2018 | Nov 9, 2022 |
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| Week 14 |
| Percentage of Psoriatic Arthritis (PsA) Participants Meeting the American College of Rheumatology 20% Improvement Criteria (ACR20) at Week 14 | ACR20 was is defined as greater than or equal to (>=) 20% improvement in swollen and tender joint count and >=20% improvement in 3 of following 5 assessments: patient's assessment of pain using Visual Analog Scale (VAS; 0-10 centimeter [cm], 0 cm=no pain and 10 cm=worst possible pain), PGA of disease activity by using VAS (the scale ranges from 0 cm to 10 cm, [0 cm=no pain to 10 cm=worst possible pain]), physician's global assessment of disease activity using VAS (scale ranges from 0 cm to 10 cm; [0 cm=very well and 10 cm=very poor]), participant's assessment of physical function measured by Health Assessment Questionnaire-Disability Index (HAQ-DI, defined as a 20-question instrument assessing 8 functional areas. The derived HAQ-DI ranges from 0, indicating no difficulty, to 3, indicating inability to perform a task in that area) and erythrocyte sedimentation rate (ESR) or C-reactive protein (CRP) level. | Week 14 |
| Percentage of AS Participants With ASAS20 Criteria at Week 24 | ASAS 20 response criteria was defined as an improvement from baseline of greater than (>) 20% and >1 unit in at least 3 of following 4 ASAS domains on scale of 0 to 10 units and no worsening from baseline of >20% and >1 unit in the remaining ASAS domain on a scale of 0 to 10 units. The 4 ASAS domains were as follows (0 to 10 units NRS): PGA of disease:0=not active spondylitis, 10=very active spondylitis; total and night Spinal pain: 0=no pain, 10=most severe pain; BASFI, self-assessment of participant's degree of mobility and functional ability represented as mean of 10 questions [8 of which relate to participant's functional anatomy and 2 relate to participant's ability to cope with everyday life): 0=easy, 10=impossible; and BASDAI, self-assessment survey of 6 questions for participant's disability due to AS): 0=none, 10=very severe).](streamdown:incomplete-link) | Week 24 |
| Percentage of PsA Participants Meeting the ACR20 Criteria at Week 24 | ACR20 was is defined as >=20% improvement in swollen and tender joint count and >=20% improvement in 3 of following 5 assessments: patient's assessment of pain using Visual Analog Scale (VAS; 0-10 centimeter [cm], 0 cm=no pain and 10 cm=worst possible pain), patient's global assessment of disease activity by using VAS (the scale ranges from 0 cm to 10 cm, [0 cm=no pain to 10 cm=worst possible pain]), PGA of disease activity using VAS (scale ranges from 0 cm to 10 cm; [0=very well and 10 cm=very poor]), participant's assessment of physical function measured by HAQ-DI, defined as a 20-question instrument assessing 8 functional areas. The derived HAQ-DI ranges from 0, indicating no difficulty, to 3, indicating inability to perform a task in that area) and ESR or CRP level. | Week 24 |
| Bhubaneswar |
| 751005 |
| India |
| Chennai Meenakshi Multispeciality Hospital | Chennai | 600004 | India |
| Nizams Institute of Medical Sciences NIMS | Hyderabad | 500082 | India |
| Apollo Multispeciality Hospital Ltd | Kolkata | 700019 | India |
| All India Institute of Medical Sciences | New Delhi | 110029 | India |
| Sir Ganga Ram Hospital | New Delhi | 110060 | India |
| Indraprastha Apollo Hospital | New Delhi | 1100776 | India |
| Sancheti Institute for Orthopedics & Rehabilitation | Pune | 411005 | India |
| Participants With Psoriatic Arthritis (PsA) |
|
| Participants With Ankylosing Spondylitis (AS) |
|
| COMPLETED |
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| NOT COMPLETED |
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|
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| ID | Title | Description |
|---|---|---|
| BG000 | Golimumab (Simponi) | Participants with active spondyloarthropathy of AS or PsA received golimumab 50 milligrams (mg) subcutaneous (SC) injection at Week 0 and every 4 weeks (q4w) thereafter through Week 24. |
| 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 |
| ||||||||||||||||||
| Race/Ethnicity, Customized | Count of Participants | Participants |
| ||||||||||||||||||
| Region of Enrollment | 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 | Number of Participants With Treatment-emergent Adverse Events (TEAEs) | An adverse event (AE) is any untoward medical occurrence in a clinical study participant administered a medicinal (investigational or non-investigational) product which does not necessarily have a causal relationship with the treatment. An AE can therefore be any unfavorable and unintended sign (including an abnormal finding), symptom, or disease temporally associated with the use of a medicinal product, whether or not related to that medicinal product. Any AE that occurred at or after the initial administration of study drug through the day of last dose plus 8 weeks was considered to be TEAE. | Safety analysis set (SAS) included all participants who were enrolled and received at least one dose of the study intervention. | Posted | Count of Participants | Participants | Up to Week 32 |
|
|
| ||||||||||||||||||||||||||||
| Primary | Number of Participants With Treatment Emergent Serious Adverse Events (SAEs) | An adverse event (AE) is any untoward medical occurrence in a clinical study participant administered a medicinal (investigational or non-investigational) product which does not necessarily have a causal relationship with the treatment. An AE can therefore be any unfavorable and unintended sign (including an abnormal finding), symptom, or disease temporally associated with the use of a medicinal product, whether or not related to that medicinal product. SAE was any untoward medical occurrence that at any dose may result in death, is life-threatening, requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect, is a suspected transmission of any infectious agent via a medicinal product. Any AE that occurred at or after the initial administration of study drug through the day of last dose plus 8 weeks was considered to be TEAE. | SAS included all participants who were enrolled and received at least one dose of the study intervention. | Posted | Count of Participants | Participants | Up to Week 32 |
|
| |||||||||||||||||||||||||||||
| Secondary | Percentage of Ankylosing Spondylitis (AS) Participants With at Least 20 Percent (%) Improvement in the Assessment of SpondyloArthritis International Society (ASAS20) Criteria at Week 14 | ASAS 20 response criteria was defined as an improvement from baseline of greater than (>)20% and >1 unit in at least 3 of following 4 ASAS domains on scale of 0-10 units and no worsening from baseline of >20% and >1 unit in the remaining ASAS domain on a scale of 0-10 units. The 4 ASAS domains were as follows (0-10 units numerical rating scale [NRS]): Patient's global assessment (PGA) of disease:0=not active spondylitis, 10=very active spondylitis; total and night Spinal pain: 0=no pain, 10=most severe pain; bath ankylosing spondylitis functional index (BASFI, self-assessment of participant's degree of mobility and functional ability represented as mean of 10 questions [8 of which relate to participant's functional anatomy and 2 relate to participant's ability to cope with everyday life): 0=easy, 10=impossible; and bath ankylosing spondylitis disease activity index (BASDAI, self-assessment survey of 6 questions for participant's disability due to AS): 0=none, 10=very severe).](streamdown:incomplete-link) | The intent to treat (ITT) analysis set included all participants who were enrolled and received at least one dose of the study drug and had completed Week 14 visit. Here, N (number of participants analyzed) is defined as the number of participants evaluable for this outcome measure. | Posted | Number | percentage of participants | Week 14 |
| ||||||||||||||||||||||||||||||
| Secondary | Percentage of Psoriatic Arthritis (PsA) Participants Meeting the American College of Rheumatology 20% Improvement Criteria (ACR20) at Week 14 | ACR20 was is defined as greater than or equal to (>=) 20% improvement in swollen and tender joint count and >=20% improvement in 3 of following 5 assessments: patient's assessment of pain using Visual Analog Scale (VAS; 0-10 centimeter [cm], 0 cm=no pain and 10 cm=worst possible pain), PGA of disease activity by using VAS (the scale ranges from 0 cm to 10 cm, [0 cm=no pain to 10 cm=worst possible pain]), physician's global assessment of disease activity using VAS (scale ranges from 0 cm to 10 cm; [0 cm=very well and 10 cm=very poor]), participant's assessment of physical function measured by Health Assessment Questionnaire-Disability Index (HAQ-DI, defined as a 20-question instrument assessing 8 functional areas. The derived HAQ-DI ranges from 0, indicating no difficulty, to 3, indicating inability to perform a task in that area) and erythrocyte sedimentation rate (ESR) or C-reactive protein (CRP) level. | The ITT analysis set included all participants who were enrolled and received at least one dose of the study drug and had completed Week 14 visit. Here, N (number of participants analyzed) is defined as the number of participants evaluable for this outcome measure. | Posted | Number | percentage of participants | Week 14 |
| ||||||||||||||||||||||||||||||
| Secondary | Percentage of AS Participants With ASAS20 Criteria at Week 24 | ASAS 20 response criteria was defined as an improvement from baseline of greater than (>) 20% and >1 unit in at least 3 of following 4 ASAS domains on scale of 0 to 10 units and no worsening from baseline of >20% and >1 unit in the remaining ASAS domain on a scale of 0 to 10 units. The 4 ASAS domains were as follows (0 to 10 units NRS): PGA of disease:0=not active spondylitis, 10=very active spondylitis; total and night Spinal pain: 0=no pain, 10=most severe pain; BASFI, self-assessment of participant's degree of mobility and functional ability represented as mean of 10 questions [8 of which relate to participant's functional anatomy and 2 relate to participant's ability to cope with everyday life): 0=easy, 10=impossible; and BASDAI, self-assessment survey of 6 questions for participant's disability due to AS): 0=none, 10=very severe).](streamdown:incomplete-link) | The ITT analysis set included all participants who were enrolled and received at least one dose of the study drug and had completed Week 24 visit. Here, N (number of participants analyzed) is defined as the number of participants evaluable for this outcome measure. | Posted | Number | percentage of participants | Week 24 |
| ||||||||||||||||||||||||||||||
| Secondary | Percentage of PsA Participants Meeting the ACR20 Criteria at Week 24 | ACR20 was is defined as >=20% improvement in swollen and tender joint count and >=20% improvement in 3 of following 5 assessments: patient's assessment of pain using Visual Analog Scale (VAS; 0-10 centimeter [cm], 0 cm=no pain and 10 cm=worst possible pain), patient's global assessment of disease activity by using VAS (the scale ranges from 0 cm to 10 cm, [0 cm=no pain to 10 cm=worst possible pain]), PGA of disease activity using VAS (scale ranges from 0 cm to 10 cm; [0=very well and 10 cm=very poor]), participant's assessment of physical function measured by HAQ-DI, defined as a 20-question instrument assessing 8 functional areas. The derived HAQ-DI ranges from 0, indicating no difficulty, to 3, indicating inability to perform a task in that area) and ESR or CRP level. | The ITT analysis set included all participants who were enrolled and received at least one dose of the study drug and had completed Week 24 visit. Here, N (number of participants analyzed) is defined as the number of participants evaluable for this outcome measure. | Posted | Number | percentage of participants | Week 24 |
|
|
Up to Week 32
Safety analysis set (SAS) included all participants who were enrolled and received at least one dose of the study intervention.
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 | Golimumab (Simponi) | Participants with active spondyloarthropathy of AS or PsA received golimumab 50 milligrams (mg) subcutaneous (SC) injection at Week 0 and every 4 weeks (q4w) thereafter through Week 24. | 0 | 100 | 4 | 100 | 28 | 100 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Abdominal Pain | Gastrointestinal disorders | MedDRA Version 24.0 | Non-systematic Assessment |
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| Diarrhoea | Gastrointestinal disorders | MedDRA Version 24.0 | Non-systematic Assessment |
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| Irritable Bowel Syndrome | Gastrointestinal disorders | MedDRA Version 24.0 | Non-systematic Assessment |
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| Lower Respiratory Tract Infection Bacterial | Infections and infestations | MedDRA Version 24.0 | Non-systematic Assessment |
| |
| Upper Respiratory Tract Infection | Infections and infestations | MedDRA Version 24.0 | Non-systematic Assessment |
| |
| Urinary Tract Infection | Infections and infestations | MedDRA Version 24.0 | Non-systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Leukopenia | Blood and lymphatic system disorders | MedDRA Version 24.0 | Non-systematic Assessment |
| |
| Vision Blurred | Eye disorders | MedDRA Version 24.0 | Non-systematic Assessment |
| |
| Aphthous Ulcer | Gastrointestinal disorders | MedDRA Version 24.0 | Non-systematic Assessment |
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| Diarrhoea | Gastrointestinal disorders | MedDRA Version 24.0 | Non-systematic Assessment |
| |
| Food Poisoning | Gastrointestinal disorders | MedDRA Version 24.0 | Non-systematic Assessment |
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| Gastritis | Gastrointestinal disorders | MedDRA Version 24.0 | Non-systematic Assessment |
| |
| Haemorrhoids | Gastrointestinal disorders | MedDRA Version 24.0 | Non-systematic Assessment |
| |
| Nausea | Gastrointestinal disorders | MedDRA Version 24.0 | Non-systematic Assessment |
| |
| Chills | General disorders | MedDRA Version 24.0 | Non-systematic Assessment |
| |
| Pain | General disorders | MedDRA Version 24.0 | Non-systematic Assessment |
| |
| Peripheral Swelling | General disorders | MedDRA Version 24.0 | Non-systematic Assessment |
| |
| Pyrexia | General disorders | MedDRA Version 24.0 | Non-systematic Assessment |
| |
| Body Tinea | Infections and infestations | MedDRA Version 24.0 | Non-systematic Assessment |
| |
| Folliculitis | Infections and infestations | MedDRA Version 24.0 | Non-systematic Assessment |
| |
| Fungal Infection | Infections and infestations | MedDRA Version 24.0 | Non-systematic Assessment |
| |
| Fungal Skin Infection | Infections and infestations | MedDRA Version 24.0 | Non-systematic Assessment |
| |
| Herpes Zoster | Infections and infestations | MedDRA Version 24.0 | Non-systematic Assessment |
| |
| Nasopharyngitis | Infections and infestations | MedDRA Version 24.0 | Non-systematic Assessment |
| |
| Tinea Pedis | Infections and infestations | MedDRA Version 24.0 | Non-systematic Assessment |
| |
| Upper Respiratory Tract Infection | Infections and infestations | MedDRA Version 24.0 | Non-systematic Assessment |
| |
| Arthropod Sting | Injury, poisoning and procedural complications | MedDRA Version 24.0 | Non-systematic Assessment |
| |
| Skin Abrasion | Injury, poisoning and procedural complications | MedDRA Version 24.0 | Non-systematic Assessment |
| |
| Blood Bilirubin Increased | Investigations | MedDRA Version 24.0 | Non-systematic Assessment |
| |
| Transaminases Increased | Investigations | MedDRA Version 24.0 | Non-systematic Assessment |
| |
| Hyperglycaemia | Metabolism and nutrition disorders | MedDRA Version 24.0 | Non-systematic Assessment |
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| Hyperuricaemia | Metabolism and nutrition disorders | MedDRA Version 24.0 | Non-systematic Assessment |
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| Hypokalaemia | Metabolism and nutrition disorders | MedDRA Version 24.0 | Non-systematic Assessment |
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| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA Version 24.0 | Non-systematic Assessment |
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| Back Pain | Musculoskeletal and connective tissue disorders | MedDRA Version 24.0 | Non-systematic Assessment |
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| Joint Swelling | Musculoskeletal and connective tissue disorders | MedDRA Version 24.0 | Non-systematic Assessment |
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| Burning Sensation | Nervous system disorders | MedDRA Version 24.0 | Non-systematic Assessment |
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| Headache | Nervous system disorders | MedDRA Version 24.0 | Non-systematic Assessment |
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| Neuralgia | Nervous system disorders | MedDRA Version 24.0 | Non-systematic Assessment |
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| Insomnia | Psychiatric disorders | MedDRA Version 24.0 | Non-systematic Assessment |
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| Nephrolithiasis | Renal and urinary disorders | MedDRA Version 24.0 | Non-systematic Assessment |
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| Vaginal Discharge | Reproductive system and breast disorders | MedDRA Version 24.0 | Non-systematic Assessment |
| |
| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA Version 24.0 | Non-systematic Assessment |
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| Alopecia | Skin and subcutaneous tissue disorders | MedDRA Version 24.0 | Non-systematic Assessment |
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| Dermatitis Allergic | Skin and subcutaneous tissue disorders | MedDRA Version 24.0 | Non-systematic Assessment |
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| Pruritus | Skin and subcutaneous tissue disorders | MedDRA Version 24.0 | Non-systematic Assessment |
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| Rash Pruritic | Skin and subcutaneous tissue disorders | MedDRA Version 24.0 | Non-systematic Assessment |
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| Hypertension | Vascular disorders | MedDRA Version 24.0 | Non-systematic Assessment |
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If an investigator wishes to publish information from the study, a copy of the manuscript must be provided to the sponsor for review at least 60 days before submission for publication or presentation. If requested by the sponsor in writing, the investigator will withhold such publication for up to an additional 60 days.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Medical Advisor Immunology | Johnson & Johnson Private Limited | 844-434-4210 | ClinicalTrialDisclosure@its.jnj.com |
| Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Jan 21, 2022 | Nov 9, 2022 | SAP_001.pdf |
Not provided
| ID | Term |
|---|---|
| D013167 | Spondylitis, Ankylosing |
| D015535 | Arthritis, Psoriatic |
| ID | Term |
|---|---|
| D000089183 | Axial Spondyloarthritis |
| D025242 | Spondylarthropathies |
| D025241 | Spondylarthritis |
| D013166 | Spondylitis |
| D013122 | Spinal Diseases |
| D001847 | Bone Diseases |
| D009140 | Musculoskeletal Diseases |
| D000844 | Ankylosis |
| D007592 | Joint Diseases |
| D001168 | Arthritis |
| D011565 | Psoriasis |
| D017444 | Skin Diseases, Papulosquamous |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| C529000 | golimumab |
Not provided
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| Participants |
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