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| ID | Type | Description | Link |
|---|---|---|---|
| CNTO148AKS3001 | Other Identifier | Janssen Research & Development, LLC | |
| 2014-000241-74 | EudraCT Number |
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The purpose of this study is to evaluate the efficacy of intravenously (administration of a fluid into the vein) administered golimumab 2 milligram per kilogram (mg/kg) in participants with active ankylosing spondylitis (chronic inflammatory disease of unknown etiology that involves the sacroiliac joints, and often the axial skeleton, entheses, and peripheral joints).
This is a Phase 3, multicenter (when more than one hospital or medical school team work on a medical research study), randomized (study drug assigned by chance), double-blind (neither the researchers nor the participants know what treatment the participant is receiving), placebo-controlled (an inactive substance; a pretend treatment [with no drug in it] that is compared in a clinical trial with a drug to test if the drug has a real effect) study of golimumab compared with placebo in participants with active ankylosing spondylitis. The study comprises of 4 phases: Screening phase (up to 6 weeks), Double-blind placebo-controlled phase (Week 0 to Week 16), Active treatment phase (Week 16 to Week 52), and Safety follow-up phase (8 weeks from last study drug administration). Total duration of the study will be 60 weeks per participant. Eligible Participants will be randomly assigned to either Treatment group 1: Placebo or Treatment group 2: Golimumab. Participants randomized to Placebo group, will receive intravenous infusions of placebo at Weeks 0, 4 and 12. At Week 16, all participants receiving placebo will begin receiving intravenous infusions of golimumab (2 mg/kg) at Weeks 16, 20 and thereafter every 8 weeks up to Week 52. Participants randomized to Golimumab group, will receive intravenous infusions of golimumab 2 mg/kg at Weeks 0, 4 and thereafter every 8 weeks up to Week 52. At Week 16, participants randomized to golimumab group will receive a placebo infusion to maintain the blind. The efficacy will be assessed primarily by measuring percentage of participants who achieve a 20 percent improvement from baseline in the assessment in ankylosing spondylitis (ASAS) at Week 16. Participant's safety will be monitored throughout the study.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Treatment Group 1: Placebo then Golimumab | Experimental | Participants will receive intravenous infusions of placebo at Weeks 0, 4 and 12. At Week 16, all participants receiving placebo will begin receiving intravenous infusions of golimumab 2 milligram per kilogram (mg/kg) at Weeks 16, 20 and thereafter every 8 weeks up to Week 52. |
|
| Treatment Group 2: Golimumab | Experimental | Participants will receive intravenous infusions of golimumab 2 mg/kg at Weeks 0, 4 and thereafter every 8 weeks up to Week 52. At Week 16, participants will receive a placebo infusion to maintain the blind. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Placebo | Drug | Participants will receive matching placebo. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Participants Who Achieved at Least 20 Percent Improvement From Baseline in the Assessment of SpondyloArthritis International Society (ASAS 20) at Week 16 | ASAS 20 defined as 20 percent (%) improvement compared to baseline in the ASAS Working Group criteria: that is, greater than or equal to (>=)20% improvement from baseline in at least 3 of the 4 domains: patient's global assessment of disease activity (0=very well,10 =very poor), total back pain (0=no pain,10=most severe pain), function (self-assessment using BASFI [0=no functional impairment to 10= maximal impairment]), inflammation (0=none,10=very severe) with an absolute improvement of at least 1 (0-10 centimeter (cm) visual analogue scale [VAS]), and an absence of deterioration (defined as >=20% worsening and absolute worsening of at least 1 on a 0-10 cm scale) in the potential remaining domain. | Week 16 |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Participants Who Achieved at Least 40 Percent Improvement From Baseline in the Assessment of SpondyloArthritis International Society (ASAS 40) at Week 16 | An ASAS 40 response is defined as >=40% improvement from baseline in 3 of 4 domains: patient's global assessment of disease activity (0=very well, 10=very poor), total back pain (0=no pain, 10=most severe pain), function (self-assessment using BASFI (0=no functional impairment to 10=maximal impairment), inflammation (0=none, 10=very severe) with an absolute improvement of at least 2 (0-10 cm VAS), and no deterioration in the remaining domain. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Janssen Research & Development, LLC Clinical Trial | Janssen Research & Development, LLC | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Glendale | Arizona | United States | ||||
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 37322274 | Derived | Deodhar A, Shiff NJ, Gong C, Chan EKH, Hsia EC, Lo KH, Akawung A, Kim L, Xu S, Reveille JD. Effect of Intravenous Golimumab on Fatigue and the Relationship with Clinical Response in Adults with Active Ankylosing Spondylitis in the Phase 3 GO-ALIVE Study. Rheumatol Ther. 2023 Aug;10(4):983-999. doi: 10.1007/s40744-023-00556-y. Epub 2023 Jun 15. | |
| 35653615 |
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Of the 312 participants screened, 208 participants were randomized (105 to golimumab 2 milligram per kilogram [mg/kg] and 103 to placebo group) and treated.
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| ID | Title | Description |
|---|---|---|
| FG000 | Group 1: Placebo Then Golimumab | Participants received placebo intravenous (IV) infusions at Weeks 0, 4, and 12. At Week 16 participants were crossed over to golimumab and received IV golimumab 2 mg/kg infusions at Weeks 16, 20, and every 8 weeks (q8w) thereafter through Week 52. |
| FG001 |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| Golimumab | Drug | Participants will receive 2mg/kg of intravenous infusions of golimumab . |
|
| Week 16 |
| Percentage of Participants Who Achieved at Least 50 Percent Improvement From Baseline in Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) at Week 16 | The BASDAI is a self-assessment tool to determine disease activity using a VAS of 0-10 cm (0=none and 10=very severe) participant's answered 6 questions measuring fatigue, spinal pain, joint pain, enthesitis, and morning stiffness. The final BASDAI is calculated as a mean of individual questions with a final score range of 0 to 10 cm; 0=best and 10=worst. | Week 16 |
| Change From Baseline in Bath Ankylosing Spondylitis Functional Index (BASFI) Score at Week 16 | The BASFI is a participant's self-assessment of physical function represented as a mean of 10 questions, each question rated on VAS 0 to 10 cm (VAS 0 to 10 cm; 0=easy to 10=impossible), 8 of which relate to the participant's functional anatomy and 2 of which relate to a participant's ability to cope with everyday life. | Baseline and Week 16 |
| Change From Baseline in Short Form-36 Health Survey (SF-36) Physical Component Summary (PCS) Score at Week 16 | The Medical Outcome Study health measure SF-36 questionnaire is a well-validated and widely used quality-of-life instrument. It is a self-administered survey that consists of 8 multi-item scales: The 4 subscales of the SF-36 comprises the PCS score (physical functioning, role-physical, bodily pain, and general health) and the 4 subscales of the SF-36 comprises the MCS score (vitality, social functioning, role-emotional, and mental health). PCS and MCS are scored from 0 to 100 with higher scores indicating better health (worst value is 0 and best value is 100), which are scored using a norm-based system where linear transformations are performed to transform scores to a mean of 50 and standard deviation of 10. | Baseline and Week 16 |
| Change From Baseline in Short Form-36 Health Survey (SF-36) Mental Component Summary (MCS) Score at Week 16 | The Medical Outcome Study health measure SF-36 questionnaire is a well-validated and widely used quality-of-life instrument. It is a self-administered survey that consists of 8 multi-item scales: The 4 subscales of the SF-36 comprises the PCS score (physical functioning, role-physical, bodily pain, and general health) and the 4 subscales of the SF-36 comprises the MCS score(vitality, social functioning, role-emotional, and mental health). PCS and MCS are scored from 0 to 100 with higher scores indicating better health (worst value is 0 and best value is 100), which are scored using a norm-based system where linear transformations are performed to transform scores to a mean of 50 and standard deviation of 10. | Baseline and Week 16 |
| Percentage of Participants With Low Level of Disease Activity (ASAS Partial Remission) at Week 16 | Low level of disease activity was measured by criteria for ASAS partial remission, defined as a value below 2 on a scale of 0 to 10 cm in each of the 4 ASAS domains: patient's global assessment of disease activity, total back pain, function (BASFI), inflammation. | Week 16 |
| Change From Baseline in Ankylosing Spondylitis Quality of Life (ASQoL) at Week 16 | The ASQoL is a self-administered health-related quality of life (HRQOL) instrument. It consists of 18 items requesting a Yes or No response to questions related to the impact of the disease/condition (including pain) on sleep, mood, motivation, ability to cope, activities of daily living, independence, relationships, and social life. A score of 1 is given to a response of "yes" on each item and all item scores are summed to a total score with a range of 0 to 18. Higher scores indicate worse HRQOL. | Baseline and Week 16 |
| Change From Baseline in Bath Ankylosing Spondylitis Metrology Index (BASMI) at Week 16 | BASMI is an objective measure of spinal mobility. The BASMI score is composed of 5 measures: tragus to wall distance, lumbar flexion, cervical rotation, lumbar side flexion, and intermalleolar distance. Each measure was scored 0-2 (0=normal mobility/mild disease involvement, 1=moderate disease involvement, 2=severe disease involvement) to give a final total BASMI score ranging from 0 to 10. The higher the BASMI score, the more severe was the participant's limitation of movement due to their AS. | Baseline and Week 16 |
| Mesa |
| Arizona |
| United States |
| La Palma | California | United States |
| Granger | Indiana | United States |
| St Louis | Missouri | United States |
| Orchard Park | New York | United States |
| Salisbury | North Carolina | United States |
| Middleburg Heights | Ohio | United States |
| Duncansville | Pennsylvania | United States |
| Austin | Texas | United States |
| Houston | Texas | United States |
| Maroochydore | Australia |
| St. John's | Newfoundland and Labrador | Canada |
| Burlington | Canada |
| Trois-Rivières | Canada |
| Bad Doberan | Germany |
| Berlin | Germany |
| Erfurt | Germany |
| Hamburg | Germany |
| Planegg | Germany |
| Ratingen | Germany |
| Zerbst | Germany |
| Chihuahua City | Mexico |
| Bydgoszcz | Poland |
| Bytom | Poland |
| Nadarzyn | Poland |
| Nowa Sól | Poland |
| Poznan | Poland |
| Warsaw | Poland |
| Moscow | Russia |
| Saint Petersburg | Russia |
| Saratov | Russia |
| Smolensk | Russia |
| Tver' | Russia |
| Ansan | South Korea |
| Daegu | South Korea |
| Gwangju | South Korea |
| Seongdong-Gu | South Korea |
| Seoul | South Korea |
| Chernihiv | Ukraine |
| Dnipropetrovsk | Ukraine |
| Kyiv | Ukraine |
| Odesa | Ukraine |
| Vinnytsia | Ukraine |
| Zaporizhzhia | Ukraine |
| Deodhar AA, Shiff NJ, Gong C, Hsia EC, Lo KH, Kim L, Xu S, Reveille JD. Efficacy and Safety of Intravenous Golimumab in Ankylosing Spondylitis Patients With Early and Late Disease Through One Year of the GO-ALIVE Study. J Clin Rheumatol. 2022 Aug 1;28(5):270-277. doi: 10.1097/RHU.0000000000001853. Epub 2022 Jun 1. |
| 35313978 | Derived | Husni ME, Deodhar A, Schwartzman S, Chakravarty SD, Hsia EC, Leu JH, Zhou Y, Lo KH, Kavanaugh A. Pooled safety results across phase 3 randomized trials of intravenous golimumab in rheumatoid arthritis, psoriatic arthritis, and ankylosing spondylitis. Arthritis Res Ther. 2022 Mar 21;24(1):73. doi: 10.1186/s13075-022-02753-6. |
| 32926247 | Derived | Reveille JD, Hwang MC, Danve A, Kafka S, Peterson S, Lo KH, Kim L, Hsia EC, Chan EKH, Deodhar A. The effect of intravenous golimumab on health-related quality of life and work productivity in adult patients with active ankylosing spondylitis: results of the phase 3 GO-ALIVE trial. Clin Rheumatol. 2021 Apr;40(4):1331-1341. doi: 10.1007/s10067-020-05342-7. Epub 2020 Sep 14. |
| 29247154 | Derived | Deodhar A, Reveille JD, Harrison DD, Kim L, Lo KH, Leu JH, Hsia EC. Safety and Efficacy of Golimumab Administered Intravenously in Adults with Ankylosing Spondylitis: Results through Week 28 of the GO-ALIVE Study. J Rheumatol. 2018 Mar;45(3):341-348. doi: 10.3899/jrheum.170487. Epub 2017 Dec 15. |
| Group 2: Golimumab |
Participants received IV golimumab 2 mg/kg infusion at Weeks 0, 4 and then q8w thereafter through Week 52. Participants received a placebo infusion at Week 16 to maintain the treatment blind. |
| End of Control Period |
|
| COMPLETED |
|
| NOT COMPLETED |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Group 1: Placebo Then Golimumab | Participants received placebo intravenous (IV) infusions at Weeks 0, 4, and 12. At Week 16 participants were crossed over to golimumab and received IV golimumab 2 mg/kg infusions at Weeks 16, 20, and every 8 weeks (q8w) thereafter through Week 52. |
| BG001 | Group 2: Golimumab | Participants received IV golimumab 2 mg/kg infusion at Weeks 0, 4 and then q8w thereafter through Week 52. Participants received a placebo infusion at Week 16 to maintain the treatment blind. |
| 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, Categorical | Count of Participants | Participants |
| ||||||||||||||||||
| Age, Continuous | Mean | Standard Deviation | years |
| |||||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| ||||||||||||||||||
| Region of Enrollment | Number | participants |
|
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Secondary | Percentage of Participants Who Achieved at Least 40 Percent Improvement From Baseline in the Assessment of SpondyloArthritis International Society (ASAS 40) at Week 16 | An ASAS 40 response is defined as >=40% improvement from baseline in 3 of 4 domains: patient's global assessment of disease activity (0=very well, 10=very poor), total back pain (0=no pain, 10=most severe pain), function (self-assessment using BASFI (0=no functional impairment to 10=maximal impairment), inflammation (0=none, 10=very severe) with an absolute improvement of at least 2 (0-10 cm VAS), and no deterioration in the remaining domain. | FAS included all participants who were randomized in the study. | Posted | Number | Percentage of Participants | Week 16 |
|
|
| |||||||||||||||||||||||||||||
| Secondary | Percentage of Participants Who Achieved at Least 50 Percent Improvement From Baseline in Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) at Week 16 | The BASDAI is a self-assessment tool to determine disease activity using a VAS of 0-10 cm (0=none and 10=very severe) participant's answered 6 questions measuring fatigue, spinal pain, joint pain, enthesitis, and morning stiffness. The final BASDAI is calculated as a mean of individual questions with a final score range of 0 to 10 cm; 0=best and 10=worst. | FAS included all participants who were randomized in the study. | Posted | Number | Percentage of Participants | Week 16 |
|
| ||||||||||||||||||||||||||||||
| Secondary | Change From Baseline in Bath Ankylosing Spondylitis Functional Index (BASFI) Score at Week 16 | The BASFI is a participant's self-assessment of physical function represented as a mean of 10 questions, each question rated on VAS 0 to 10 cm (VAS 0 to 10 cm; 0=easy to 10=impossible), 8 of which relate to the participant's functional anatomy and 2 of which relate to a participant's ability to cope with everyday life. | FAS included all participants who were randomized in the study. Here, 'N' (Number of participants analyzed) signifies number of participants who were evaluable for this outcome measure. | Posted | Mean | Standard Deviation | Units on a Scale | Baseline and Week 16 |
|
| |||||||||||||||||||||||||||||
| Primary | Percentage of Participants Who Achieved at Least 20 Percent Improvement From Baseline in the Assessment of SpondyloArthritis International Society (ASAS 20) at Week 16 | ASAS 20 defined as 20 percent (%) improvement compared to baseline in the ASAS Working Group criteria: that is, greater than or equal to (>=)20% improvement from baseline in at least 3 of the 4 domains: patient's global assessment of disease activity (0=very well,10 =very poor), total back pain (0=no pain,10=most severe pain), function (self-assessment using BASFI [0=no functional impairment to 10= maximal impairment]), inflammation (0=none,10=very severe) with an absolute improvement of at least 1 (0-10 centimeter (cm) visual analogue scale [VAS]), and an absence of deterioration (defined as >=20% worsening and absolute worsening of at least 1 on a 0-10 cm scale) in the potential remaining domain. | The full analysis set (FAS) included all participants who were randomized in the study. | Posted | Number | Percentage of Participants | Week 16 |
| |||||||||||||||||||||||||||||||
| Secondary | Change From Baseline in Short Form-36 Health Survey (SF-36) Physical Component Summary (PCS) Score at Week 16 | The Medical Outcome Study health measure SF-36 questionnaire is a well-validated and widely used quality-of-life instrument. It is a self-administered survey that consists of 8 multi-item scales: The 4 subscales of the SF-36 comprises the PCS score (physical functioning, role-physical, bodily pain, and general health) and the 4 subscales of the SF-36 comprises the MCS score (vitality, social functioning, role-emotional, and mental health). PCS and MCS are scored from 0 to 100 with higher scores indicating better health (worst value is 0 and best value is 100), which are scored using a norm-based system where linear transformations are performed to transform scores to a mean of 50 and standard deviation of 10. | FAS included all participants who were randomized in the study. Here, 'N' (Number of participants analyzed) signifies number of participants who were evaluable for this outcome measure. | Posted | Mean | Standard Deviation | Units on a Scale | Baseline and Week 16 |
| ||||||||||||||||||||||||||||||
| Secondary | Change From Baseline in Short Form-36 Health Survey (SF-36) Mental Component Summary (MCS) Score at Week 16 | The Medical Outcome Study health measure SF-36 questionnaire is a well-validated and widely used quality-of-life instrument. It is a self-administered survey that consists of 8 multi-item scales: The 4 subscales of the SF-36 comprises the PCS score (physical functioning, role-physical, bodily pain, and general health) and the 4 subscales of the SF-36 comprises the MCS score(vitality, social functioning, role-emotional, and mental health). PCS and MCS are scored from 0 to 100 with higher scores indicating better health (worst value is 0 and best value is 100), which are scored using a norm-based system where linear transformations are performed to transform scores to a mean of 50 and standard deviation of 10. | FAS included all participants who were randomized in the study. Here, 'N' (Number of participants analyzed) signifies number of participants who were evaluable for this outcome measure. | Posted | Mean | Standard Deviation | Units on a Scale | Baseline and Week 16 |
| ||||||||||||||||||||||||||||||
| Secondary | Percentage of Participants With Low Level of Disease Activity (ASAS Partial Remission) at Week 16 | Low level of disease activity was measured by criteria for ASAS partial remission, defined as a value below 2 on a scale of 0 to 10 cm in each of the 4 ASAS domains: patient's global assessment of disease activity, total back pain, function (BASFI), inflammation. | FAS included all participants who were randomized in the study. | Posted | Number | Percentage of Participants | Week 16 |
|
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| Secondary | Change From Baseline in Ankylosing Spondylitis Quality of Life (ASQoL) at Week 16 | The ASQoL is a self-administered health-related quality of life (HRQOL) instrument. It consists of 18 items requesting a Yes or No response to questions related to the impact of the disease/condition (including pain) on sleep, mood, motivation, ability to cope, activities of daily living, independence, relationships, and social life. A score of 1 is given to a response of "yes" on each item and all item scores are summed to a total score with a range of 0 to 18. Higher scores indicate worse HRQOL. | FAS included all participants who were randomized in the study. Here, 'N' (Number of participants analyzed) signifies number of participants who were evaluable for this outcome measure. | Posted | Mean | Standard Deviation | Units on Scale | Baseline and Week 16 |
| ||||||||||||||||||||||||||||||
| Secondary | Change From Baseline in Bath Ankylosing Spondylitis Metrology Index (BASMI) at Week 16 | BASMI is an objective measure of spinal mobility. The BASMI score is composed of 5 measures: tragus to wall distance, lumbar flexion, cervical rotation, lumbar side flexion, and intermalleolar distance. Each measure was scored 0-2 (0=normal mobility/mild disease involvement, 1=moderate disease involvement, 2=severe disease involvement) to give a final total BASMI score ranging from 0 to 10. The higher the BASMI score, the more severe was the participant's limitation of movement due to their AS. | FAS included all participants who were randomized in the study. Here, 'N' (Number of participants analyzed) signifies number of participants who were evaluable for this outcome measure. | Posted | Mean | Standard Deviation | Units on Scale | Baseline and Week 16 |
|
Up to 60 weeks
Safety Analysis set included all participants who received at least 1 dose of study drug. Participants who received placebo and crossed over to golimumab were included in placebo then golimumab 2 mg/kg arm and who received at least 1 dose of golimumab were included in placebo then golimumab 2 mg/kg and golimumab 2 mg/kg arms for safety analysis.
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 | Placebo | Participants who received placebo only (at least 1 dose) through Week 16. Follow-up was based on the period the participant was receiving placebo (from Week 0) up to the first golimumab 2 mg/kg dose for this treatment group. | 0 | 103 | 3 | 103 | ||
| EG001 | Placebo Then Golimumab 2 mg/kg | Participants who received placebo were crossed over to golimumab 2 mg/kg at Week 16. Participants may have also inadvertently received golimumab 2 mg/kg prior to Week 16. Participants may have missed one or more golimumab doses. Follow-up started from the first golimumab 2 mg/kg dose for this treatment group. Participants who inadvertently received golimumab 2 mg/kg prior to Week 16 were applicable to include in this group. | 1 | 99 | 16 | 99 | ||
| EG002 | Golimumab 2 mg/kg | Participants who received at least one dose of 2 mg/kg golimumab from Week 0 onward. Follow-up started from the first golimumab 2 mg/kg dose for this treatment group. | 6 | 105 | 32 | 105 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Sinus tachycardia | Cardiac disorders | MedDRA Version 19.0 | Non-systematic Assessment |
| |
| Pancreatitis | Gastrointestinal disorders | MedDRA Version 19.0 | Non-systematic Assessment |
| |
| Non-alcoholic steatohepatitis | Hepatobiliary disorders | MedDRA Version 19.0 | Non-systematic Assessment |
| |
| Appendicitis | Infections and infestations | MedDRA Version 19.0 | Non-systematic Assessment |
| |
| Pneumonia | Infections and infestations | MedDRA Version 19.0 | Non-systematic Assessment |
| |
| Pulmonary tuberculosis | Infections and infestations | MedDRA Version 19.0 | Non-systematic Assessment |
| |
| Wrist fracture | Injury, poisoning and procedural complications | MedDRA Version 19.0 | Non-systematic Assessment |
| |
| Henoch-Schonlein purpura | Skin and subcutaneous tissue disorders | MedDRA Version 19.0 | Non-systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Nasopharyngitis | Infections and infestations | MedDRA Version 19.0 | Non-systematic Assessment |
| |
| Upper respiratory tract infection | Infections and infestations | MedDRA Version 19.0 | Non-systematic Assessment |
| |
| Alanine aminotransferase increased | Investigations | MedDRA Version 19.0 | Non-systematic Assessment |
| |
| Headache | Nervous system disorders | MedDRA Version 19.0 | Non-systematic Assessment |
|
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 | |
|---|---|---|---|---|
| Senior Director Clinical Development, Immunology General | Johnson&Johnson | ClinicalTrialDisclosure@its.jnj.com |
| ID | Term |
|---|---|
| D013167 | Spondylitis, Ankylosing |
| 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 |
Not provided
Not provided
| ID | Term |
|---|---|
| C529000 | golimumab |
Not provided
Not provided
Not provided
| >=65 years |
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| Male |
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| Germany |
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| Mexico |
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| Poland |
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| Russian Federation |
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| South Korea |
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| Ukraine |
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| United States |
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