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The purpose of study is to explore the effect of CP-690,550 (tasocitinib) on cholesterol metabolism in patients with active rheumatoid arthritis (RA).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| CP-690,550 (tasocitinib) 10 mg twice daily (BID) | Experimental |
| |
| Healthy Volunteers | No Intervention | No intervention |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| CP-690,550 (tasocitinib) | Drug | CP-690,550 (tasocitinib) dosed at 10 mg BID for 6 weeks in patients with active rheumatoid arthritis |
|
| Measure | Description | Time Frame |
|---|---|---|
| High-density Lipoprotein Cholesterol (HDL-C) Concentration at Baseline | Blood level of HDL-C was measured following a 12-hours fasting. | Baseline |
| High-density Lipoprotein Cholesterol (HDL-C) Concentration at Week 6 | Blood level of HDL-C was measured following a 12-hours fasting. | Week 6 |
| Cholesterol Ester Production Rate at Baseline | Cholesterol ester production rate was calculated using a 3-pool model with a simulation, analysis and modeling (SAAM II) program. | Baseline |
| Cholesterol Ester Production Rate at Week 6 | Cholesterol ester production rate was calculated using a 3-pool model with a simulation, analysis and modeling (SAAM II) program. | Week 6 |
| Measure | Description | Time Frame |
|---|---|---|
| Low-density Lipoprotein Cholesterol (LDL-C) and Total Cholesterol Concentration | Blood level of LDL-C and total cholesterol (TC) was measured following a 12-hours fasting. | Baseline, Week 6 |
| Cholesterol Ester Fractional Catabolic Rate |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Pfizer CT.gov Call Center | Pfizer | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Pfizer Investigational Site | Anniston | Alabama | 36201 | United States | ||
| Pfizer Investigational Site |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 36931693 | Derived | Kristensen LE, Danese S, Yndestad A, Wang C, Nagy E, Modesto I, Rivas J, Benda B. Identification of two tofacitinib subpopulations with different relative risk versus TNF inhibitors: an analysis of the open label, randomised controlled study ORAL Surveillance. Ann Rheum Dis. 2023 Jul;82(7):901-910. doi: 10.1136/ard-2022-223715. Epub 2023 Mar 17. | |
| 36601090 |
| Label | URL |
|---|---|
| To obtain contact information for a study center near you, click here. | View source |
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| ID | Title | Description |
|---|---|---|
| FG000 | Rheumatoid Arthritis Cohort | Active rheumatoid arthritis participants were assessed for baseline cholesterol flux kinetics for 3 days and then received CP-690,550 10 mg tablet orally twice daily for 6 weeks. |
| FG001 | Healthy Volunteers Cohort |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Baseline Assessment Period (3 Days) |
|
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Cholesterol ester fractional catabolic rate were calculated using a 3-pool model with a simulation, analysis and modeling (SAAM II) program. Fractional catabolic rate was the percentage of cholesterol ester which was replaced, transferred or lost per unit of time.
| Baseline, Week 6 |
| Low-density Lipoprotein Associated With Apolipoprotein B (LDL-apoB) Production Rate | LDL-apoB production rate were calculated using a 3-pool model with a simulation, analysis and modeling (SAAM II) program. | Baseline, Week 6 |
| Low-density Lipoprotein Associated With Apolipoprotein B (LDL-apoB) Fractional Catabolic Rate | Fractional catabolic rate for LDL ApoB were calculated using the 13 carbon (13C) isotopic enrichment of very low density lipoprotein (VLDL) as the limiting value. Isotope 13C in plasma was measured using Gas Chromatography-Combustion-Isotope Ratio Mass Spectrometry (GC-C-IRMS). | Baseline, Week 6 |
| High-density Lipoprotein Associated With Apolipoprotein A1 (HDL-apoA1) Production Rate | HDL-apoA1 production rate were calculated using a 3-pool model with a simulation, analysis and modeling (SAAM II) program. | Baseline, Week 6 |
| High-density Lipoprotein Associated With Apolipoprotein A1 (HDL-apoA1) Fractional Catabolic Rate | Fractional catabolic rate for HDL-apoA1 were calculated using the 13C isotopic enrichment of VLDL as the limiting value. Isotope 13C in plasma was measured using GC-C-IRMS. | Baseline, Week 6 |
| Cholesterol Efflux Rate | Cholesterol efflux rate was measured using isotope dilution method in which rate of appearance of isotope 13C-free cholesterol in plasma representing whole body efflux from tissues was assessed. Isotope 13C in plasma was measured using GC-C-IRMS. | Baseline, Week 6 |
| Anniston |
| Alabama |
| 36207 |
| United States |
| Pfizer Investigational Site | Little Rock | Arkansas | 72201 | United States |
| Pfizer Investigational Site | Los Angeles | California | 90095 | United States |
| Pfizer Investigational Site | Daytona Beach | Florida | 32114 | United States |
| Pfizer Investigational Site | Ormond Beach | Florida | 32174 | United States |
| Pfizer Investigational Site | South Miami | Florida | 33143 | United States |
| Pfizer Investigational Site | Bingham Farms | Michigan | 48025 | United States |
| Pfizer Investigational Site | Dallas | Texas | 75231 | United States |
| Pfizer Investigational Site | Balatonfüred | 8230 | Hungary |
| Pfizer Investigational Site | Budapest | 1032 | Hungary |
| Hansen KE, Mortezavi M, Nagy E, Wang C, Connell CA, Radi Z, Litman HJ, Adami G, Rossini M. Fracture in clinical studies of tofacitinib in rheumatoid arthritis. Ther Adv Musculoskelet Dis. 2022 Dec 27;14:1759720X221142346. doi: 10.1177/1759720X221142346. eCollection 2022. |
| 36600185 | Derived | Curtis JR, Yamaoka K, Chen YH, Bhatt DL, Gunay LM, Sugiyama N, Connell CA, Wang C, Wu J, Menon S, Vranic I, Gomez-Reino JJ. Malignancy risk with tofacitinib versus TNF inhibitors in rheumatoid arthritis: results from the open-label, randomised controlled ORAL Surveillance trial. Ann Rheum Dis. 2023 Mar;82(3):331-343. doi: 10.1136/ard-2022-222543. Epub 2022 Dec 5. |
| 36526796 | Derived | Winthrop KL, Yndestad A, Henrohn D, Danese S, Marsal S, Galindo M, Woolcott JC, Jo H, Kwok K, Shapiro AB, Jones TV, Diehl A, Su C, Panes J, Cohen SB. Influenza Adverse Events in Patients with Rheumatoid Arthritis, Ulcerative Colitis, or Psoriatic Arthritis in the Tofacitinib Clinical Development Programs. Rheumatol Ther. 2023 Apr;10(2):357-373. doi: 10.1007/s40744-022-00507-z. Epub 2022 Dec 17. |
| 34870800 | Derived | Winthrop KL, Curtis JR, Yamaoka K, Lee EB, Hirose T, Rivas JL, Kwok K, Burmester GR. Clinical Management of Herpes Zoster in Patients With Rheumatoid Arthritis or Psoriatic Arthritis Receiving Tofacitinib Treatment. Rheumatol Ther. 2022 Feb;9(1):243-263. doi: 10.1007/s40744-021-00390-0. Epub 2021 Dec 6. |
| 33127856 | Derived | Cohen SB, Tanaka Y, Mariette X, Curtis JR, Lee EB, Nash P, Winthrop KL, Charles-Schoeman C, Wang L, Chen C, Kwok K, Biswas P, Shapiro A, Madsen A, Wollenhaupt J. Long-term safety of tofacitinib up to 9.5 years: a comprehensive integrated analysis of the rheumatoid arthritis clinical development programme. RMD Open. 2020 Oct;6(3):e001395. doi: 10.1136/rmdopen-2020-001395. |
| 32816215 | Derived | Panaccione R, Isaacs JD, Chen LA, Wang W, Marren A, Kwok K, Wang L, Chan G, Su C. Characterization of Creatine Kinase Levels in Tofacitinib-Treated Patients with Ulcerative Colitis: Results from Clinical Trials. Dig Dis Sci. 2021 Aug;66(8):2732-2743. doi: 10.1007/s10620-020-06560-4. Epub 2020 Aug 20. |
| 28143815 | Derived | Cohen SB, Tanaka Y, Mariette X, Curtis JR, Lee EB, Nash P, Winthrop KL, Charles-Schoeman C, Thirunavukkarasu K, DeMasi R, Geier J, Kwok K, Wang L, Riese R, Wollenhaupt J. Long-term safety of tofacitinib for the treatment of rheumatoid arthritis up to 8.5 years: integrated analysis of data from the global clinical trials. Ann Rheum Dis. 2017 Jul;76(7):1253-1262. doi: 10.1136/annrheumdis-2016-210457. Epub 2017 Jan 31. |
| 25470338 | Derived | Charles-Schoeman C, Fleischmann R, Davignon J, Schwartz H, Turner SM, Beysen C, Milad M, Hellerstein MK, Luo Z, Kaplan IV, Riese R, Zuckerman A, McInnes IB. Potential mechanisms leading to the abnormal lipid profile in patients with rheumatoid arthritis versus healthy volunteers and reversal by tofacitinib. Arthritis Rheumatol. 2015 Mar;67(3):616-25. doi: 10.1002/art.38974. |
| 25047021 | Derived | Cohen S, Radominski SC, Gomez-Reino JJ, Wang L, Krishnaswami S, Wood SP, Soma K, Nduaka CI, Kwok K, Valdez H, Benda B, Riese R. Analysis of infections and all-cause mortality in phase II, phase III, and long-term extension studies of tofacitinib in patients with rheumatoid arthritis. Arthritis Rheumatol. 2014 Nov;66(11):2924-37. doi: 10.1002/art.38779. |
Healthy volunteers with similar baseline demographic characteristics as the active rheumatoid arthritis participants were assessed for baseline cholesterol flux kinetics for 3 days. |
| COMPLETED |
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| NOT COMPLETED |
|
| Treatment Period (6 Weeks) |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Rheumatoid Arthritis Cohort | Active rheumatoid arthritis participants were assessed for baseline cholesterol flux kinetics for 3 days and then received CP-690,550 10 mg tablet orally twice daily for 6 weeks. |
| BG001 | Healthy Volunteers Cohort | Healthy volunteers with similar baseline demographic characteristics as the active rheumatoid arthritis participants were assessed for baseline cholesterol flux kinetics for 3 days. |
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | |||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Customized | Number | participants |
| |||||||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
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| 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 | High-density Lipoprotein Cholesterol (HDL-C) Concentration at Baseline | Blood level of HDL-C was measured following a 12-hours fasting. | Full analysis set (FAS) included all enrolled participants who had any measurement of cholesterol ester production rate available. | Posted | Mean | Standard Deviation | milligram per deciliter (mg/dL) | Baseline |
|
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| ||||||||||||||||||||||||||||
| Primary | High-density Lipoprotein Cholesterol (HDL-C) Concentration at Week 6 | Blood level of HDL-C was measured following a 12-hours fasting. | FAS included all enrolled participants who had any measurement of cholesterol ester production rate available. | Posted | Mean | Standard Deviation | mg/dL | Week 6 |
|
| |||||||||||||||||||||||||||||
| Primary | Cholesterol Ester Production Rate at Baseline | Cholesterol ester production rate was calculated using a 3-pool model with a simulation, analysis and modeling (SAAM II) program. | FAS included all enrolled participants who had any measurement of cholesterol ester production rate available. Here, 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure. | Posted | Mean | Standard Deviation | (mg per kilogram) per hour ([mg/kg]/hr) | Baseline |
|
| |||||||||||||||||||||||||||||
| Primary | Cholesterol Ester Production Rate at Week 6 | Cholesterol ester production rate was calculated using a 3-pool model with a simulation, analysis and modeling (SAAM II) program. | FAS included all enrolled participants who had any measurement of cholesterol ester production rate available. Here, 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure. | Posted | Mean | Standard Deviation | (mg/kg)/hr | Week 6 |
|
| |||||||||||||||||||||||||||||
| Secondary | Low-density Lipoprotein Cholesterol (LDL-C) and Total Cholesterol Concentration | Blood level of LDL-C and total cholesterol (TC) was measured following a 12-hours fasting. | FAS included all enrolled participants who had any measurement of cholesterol ester production rate available. | Posted | Mean | Standard Deviation | mg/dL | Baseline, Week 6 |
|
| |||||||||||||||||||||||||||||
| Secondary | Cholesterol Ester Fractional Catabolic Rate | Cholesterol ester fractional catabolic rate were calculated using a 3-pool model with a simulation, analysis and modeling (SAAM II) program. Fractional catabolic rate was the percentage of cholesterol ester which was replaced, transferred or lost per unit of time. | FAS included all enrolled participants who had any measurement of cholesterol ester production rate available. Here, 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure. | Posted | Mean | Standard Deviation | percentage ester per hour (%/hr) | Baseline, Week 6 |
|
| |||||||||||||||||||||||||||||
| Secondary | Low-density Lipoprotein Associated With Apolipoprotein B (LDL-apoB) Production Rate | LDL-apoB production rate were calculated using a 3-pool model with a simulation, analysis and modeling (SAAM II) program. | FAS included all enrolled participants who had any measurement of cholesterol ester production rate available. Here, 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure. | Posted | Mean | Standard Deviation | (mg/kg)/hr | Baseline, Week 6 |
|
| |||||||||||||||||||||||||||||
| Secondary | Low-density Lipoprotein Associated With Apolipoprotein B (LDL-apoB) Fractional Catabolic Rate | Fractional catabolic rate for LDL ApoB were calculated using the 13 carbon (13C) isotopic enrichment of very low density lipoprotein (VLDL) as the limiting value. Isotope 13C in plasma was measured using Gas Chromatography-Combustion-Isotope Ratio Mass Spectrometry (GC-C-IRMS). | FAS included all enrolled participants who had any measurement of cholesterol ester production rate available. Here, 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure. | Posted | Mean | Standard Deviation | %/hr | Baseline, Week 6 |
|
| |||||||||||||||||||||||||||||
| Secondary | High-density Lipoprotein Associated With Apolipoprotein A1 (HDL-apoA1) Production Rate | HDL-apoA1 production rate were calculated using a 3-pool model with a simulation, analysis and modeling (SAAM II) program. | FAS included all enrolled participants who had any measurement of cholesterol ester production rate available. Here, 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure. | Posted | Mean | Standard Deviation | mg/kg/hr | Baseline, Week 6 |
|
| |||||||||||||||||||||||||||||
| Secondary | High-density Lipoprotein Associated With Apolipoprotein A1 (HDL-apoA1) Fractional Catabolic Rate | Fractional catabolic rate for HDL-apoA1 were calculated using the 13C isotopic enrichment of VLDL as the limiting value. Isotope 13C in plasma was measured using GC-C-IRMS. | FAS included all enrolled participants who had any measurement of cholesterol ester production rate available. Here, 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure. | Posted | Mean | Standard Deviation | %/hr | Baseline, Week 6 |
|
| |||||||||||||||||||||||||||||
| Secondary | Cholesterol Efflux Rate | Cholesterol efflux rate was measured using isotope dilution method in which rate of appearance of isotope 13C-free cholesterol in plasma representing whole body efflux from tissues was assessed. Isotope 13C in plasma was measured using GC-C-IRMS. | FAS included all enrolled participants who had any measurement of cholesterol ester production rate available. Here, 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure. | Posted | Mean | Standard Deviation | (mg/kg)/hr | Baseline, Week 6 |
|
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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 | Rheumatoid Arthritis Cohort | Active rheumatoid arthritis participants were assessed for baseline cholesterol flux kinetics for 3 days and then received CP-690,550 10 mg tablet orally twice daily for 6 weeks. | 0 | 36 | 19 | 36 | ||
| EG001 | Healthy Volunteer Cohort | Healthy volunteers with similar baseline demographic characteristics as the active rheumatoid arthritis participants were assessed for baseline cholesterol flux kinetics for 3 days. | 0 | 33 | 6 | 33 |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Abdominal distension | Gastrointestinal disorders | MedDRA v15.0 | Non-systematic Assessment |
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| Abdominal pain upper | Gastrointestinal disorders | MedDRA v15.0 | Non-systematic Assessment |
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| Diarrhoea | Gastrointestinal disorders | MedDRA v15.0 | Non-systematic Assessment |
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| Dyspepsia | Gastrointestinal disorders | MedDRA v15.0 | Non-systematic Assessment |
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| Gastrooesophageal reflux disease | Gastrointestinal disorders | MedDRA v15.0 | Non-systematic Assessment |
| |
| Nausea | Gastrointestinal disorders | MedDRA v15.0 | Non-systematic Assessment |
| |
| Toothache | Gastrointestinal disorders | MedDRA v15.0 | Non-systematic Assessment |
| |
| Vomiting | Gastrointestinal disorders | MedDRA v15.0 | Non-systematic Assessment |
| |
| Irritability | General disorders | MedDRA v15.0 | Non-systematic Assessment |
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| Oedema peripheral | General disorders | MedDRA v15.0 | Non-systematic Assessment |
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| Sinusitis | Infections and infestations | MedDRA v15.0 | Non-systematic Assessment |
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| Upper respiratory tract infection | Infections and infestations | MedDRA v15.0 | Non-systematic Assessment |
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| Urinary tract infection | Infections and infestations | MedDRA v15.0 | Non-systematic Assessment |
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| Epicondylitis | Injury, poisoning and procedural complications | MedDRA v15.0 | Non-systematic Assessment |
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| Fall | Injury, poisoning and procedural complications | MedDRA v15.0 | Non-systematic Assessment |
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| Blood pressure increased | Investigations | MedDRA v15.0 | Non-systematic Assessment |
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| Decreased appetite | Metabolism and nutrition disorders | MedDRA v15.0 | Non-systematic Assessment |
| |
| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA v15.0 | Non-systematic Assessment |
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| Arthritis | Musculoskeletal and connective tissue disorders | MedDRA v15.0 | Non-systematic Assessment |
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| Back pain | Musculoskeletal and connective tissue disorders | MedDRA v15.0 | Non-systematic Assessment |
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| Costochondritis | Musculoskeletal and connective tissue disorders | MedDRA v15.0 | Non-systematic Assessment |
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| Musculoskeletal pain | Musculoskeletal and connective tissue disorders | MedDRA v15.0 | Non-systematic Assessment |
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| Tendonitis | Musculoskeletal and connective tissue disorders | MedDRA v15.0 | Non-systematic Assessment |
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| Dizziness | Nervous system disorders | MedDRA v15.0 | Non-systematic Assessment |
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| Headache | Nervous system disorders | MedDRA v15.0 | Non-systematic Assessment |
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| Migraine | Nervous system disorders | MedDRA v15.0 | Non-systematic Assessment |
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| Sciatica | Nervous system disorders | MedDRA v15.0 | Non-systematic Assessment |
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| Anxiety | Psychiatric disorders | MedDRA v15.0 | Non-systematic Assessment |
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| Dysuria | Renal and urinary disorders | MedDRA v15.0 | Non-systematic Assessment |
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| Haematuria | Renal and urinary disorders | MedDRA v15.0 | Non-systematic Assessment |
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| Rash | Skin and subcutaneous tissue disorders | MedDRA v15.0 | Non-systematic Assessment |
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Pfizer has the right to review disclosures, requesting a delay of less than 60 days. Investigator will postpone single center publications until after disclosure of pooled data (all sites), less than 12 months from study completion/termination at all participating sites. Investigator may not disclose previously undisclosed confidential information other than study results.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Pfizer ClinicalTrials.gov Call Center | Pfizer, Inc. | 1-800-718-1021 | ClinicalTrials.gov_Inquiries@pfizer.com |
| ID | Term |
|---|---|
| D001172 | Arthritis, Rheumatoid |
| ID | Term |
|---|---|
| D001168 | Arthritis |
| D007592 | Joint Diseases |
| D009140 | Musculoskeletal Diseases |
| D012216 | Rheumatic Diseases |
| D003240 | Connective Tissue Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D001327 | Autoimmune Diseases |
| D007154 | Immune System Diseases |
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| ID | Term |
|---|---|
| C479163 | tofacitinib |
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| Title | Measurements |
|---|---|
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| Greater than or equal to (>=) 65 years |
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| Male |
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