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| ID | Type | Description | Link |
|---|---|---|---|
| 2014-000706-34 | EudraCT Number |
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This study will evaluate immune response following administration of zoster vaccine in subjects with rheumatoid arthritis who are receiving background methotrexate and initiate 5 mg twice daily of tofacitinib or placebo for tofacitinib 2 to 3 weeks following vaccination.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Tofacitinib 5 mg BID (oral) (70 subjects) | Experimental | Zoster vaccine will be administered to subjects on background methotrexate; treatment with 5 mg tofacitinib twice daily will begin 2 to 3 weeks following vaccination and continue for 12 weeks. |
|
| Placebo tofacitinib BID (oral) (70 subjects) | Placebo Comparator | Zoster vaccine will be administered to subjects on background methotrexate; treatment with placebo twice daily will begin 2 to 3 weeks following vaccination and continue for 12 weeks. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Tofacitinib | Drug | 5 mg twice daily of tofacitinib with background methotrexate for 12 weeks |
|
| Measure | Description | Time Frame |
|---|---|---|
| Fold Change From Baseline in Varicella Zoster Virus (VZV)-Specific Immunoglobulin G (IgG) Levels at Week 4 | VZV-specific IgG levels as measured by enzyme-linked immunosorbent assay (ELISA). | Baseline (pre-vaccination; Day -14), Week 4 (6 weeks post-vaccination) |
| Measure | Description | Time Frame |
|---|---|---|
| Fold Change From Baseline in VZV-Specific IgG Levels at Day 1 and Week 12 | Baseline (pre-vaccination; Day -14), Day 1 (2 weeks post-vaccination), Week 12 (14 weeks post-vaccination) | |
| Absolute Values in VZV-Specific IgG Levels at Day 1, Week 4 and Week 12 |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants With Treatment-Emergent Adverse Events (AEs) or Serious Adverse Events (SAEs) | An AE was any untoward medical occurrence in a participant who received study drug. An SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. Treatment-emergent are events between first dose of study drug and up to Week 16 that were absent before treatment or that worsened relative to pre-treatment state. AEs included both SAEs and non-SAEs. |
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 |
|---|---|---|---|---|---|---|
| NEA Baptist Clinic | Jonesboro | Arkansas | 72401 | United States | ||
| Drug Shipping Address (IRB# 14-000826) Ronald Regan |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 39192350 | Derived | Hetland ML, Strangfeld A, Bonfanti G, Soudis D, Deuring JJ, Edwards RA. Machine learning prediction and explanatory models of serious infections in patients with rheumatoid arthritis treated with tofacitinib. Arthritis Res Ther. 2024 Aug 27;26(1):153. doi: 10.1186/s13075-024-03376-9. | |
| 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. |
| Label | URL |
|---|---|
| To obtain contact information for a study center near you, click here. | View source |
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The zoster vaccine was administered at least 2 weeks (14 to 21 days) prior to initiation of CP-690,550 (tofacitinib) or placebo in rheumatoid arthritis (RA) participants on background methotrexate therapy.
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| ID | Title | Description |
|---|---|---|
| FG000 | Placebo Twice a Day | Following administration of zoster vaccine, participants with Rheumatoid Arthritis (RA) on background methotrexate received placebo matched tofacitinib tablets twice a day orally for up to 12 weeks. |
| FG001 | Tofacitinib 5 mg Twice a Day |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| Placebo | Drug | Placebo tablets twice daily with background methotrexate for 12 weeks |
|
The absolute geometric mean titer (GMT) of VZV-specific IgG levels was calculated from logarithmically transformed assay values.
| Day 1 (2 weeks post-vaccination), Week 4 (6 weeks post-vaccination), Week 12 (14 weeks post-vaccination) |
| Percentage of Participants With >=1.5 Fold Change in VZV-Specific IgG Levels Day 1, Week 4 and Week 12 | VZV-specific IgG levels as measured by ELISA. A ratio greater than or equal to (>=)1.5 was defined as a responder. | Day 1 (2 weeks post-vaccination), Week 4 (6 weeks post-vaccination), Week 12 (14 weeks post-vaccination) |
| Baseline up to Week 16 |
| Number of Participants With Zoster Vaccine-Related AEs by System Organ Class | Zoster vaccine-related AEs included General Disorders and Administration Site Conditions (injection site erythema, pain, pruritis, rash, swelling; vaccination site erythema, pruritus, rash), Infections and Infestations (disseminated herpes zoster), and Musculoskeletal and Connective Tissue Disorders (myalgia). All zoster vaccine-related AEs were mild, except for the herpes zoster AE classified under Infections and Infestations, which was moderate in severity. | Baseline up to Week 16 |
| Number of Participants With Clinical Herpes Zoster Events by Severity | Clinical herpes is manifested as mild, moderate, or severe disseminated herpes zoster. | Baseline up to Week 16 |
| Number of Participants With Clinically Significant Abnormal Laboratory Parameters | Participants with the following abnormalities were discontinued from the study: 2 sequential absolute neutrophil counts (ANC) <1000/mm^3; 2 sequential hemoglobin values <8.0 g/dL or decreases of >30% from baseline value; 2 sequential absolute lymphocyte count <500/mm^3; 2 sequential platelet counts <75,000/mm^3; 2 sequential alanine aminotransferase (ALT) or aspartate aminotransferase (AST) elevations >=3 times the upper limit of normal (X ULN) with a total bilirubin value >=2X ULN, elevated international normalized ratio (INR), or accompanied by signs/symptoms consistent with hepatic injury; 2 sequential ALT or AST elevations >=5X ULN regardless of total bilirubin or accompanying symptoms; confirmed increases in serum creatinine (SCr) >50% over the average of screening and baseline values; a confirmed positive urine pregnancy test or refusal to use appropriate contraception in a woman of childbearing potential. | Baseline up to Week 16 |
| Los Angeles |
| California |
| 90095 |
| United States |
| UCLA David Geffen School of Medicine | Los Angeles | California | 90095 | United States |
| Pacific Arthritis Center Medical Group | Santa Maria | California | 93454 | United States |
| Inland Rheumatology Clinical Trials, Inc. | Upland | California | 91786 | United States |
| Jacksonville Center for Clinical Research | Jacksonville | Florida | 32216 | United States |
| Center for Arthritis and Rheumatic Diseases | Miami | Florida | 33173 | United States |
| Suncoast Clinical Research, Inc. | New Port Richey | Florida | 34652 | United States |
| DMI Research, Inc. | Pinellas Park | Florida | 33782 | United States |
| Florida Arthritis and Osteoporosis Center | Port Richey | Florida | 34668 | United States |
| Gulf Coast Medical Center | Port Richey | Florida | 34668 | United States |
| Sarasota Arthritis Research Center | Sarasota | Florida | 34239 | United States |
| Suncoast Medical Clinic | St. Petersburg | Florida | 33705 | United States |
| Sun Coast Medical Clinic | St. Petersburg | Florida | 33710 | United States |
| Health Point Medical Group, Inc. | Tampa | Florida | 33614 | United States |
| Deerbrook Medical Associates | Vernon Hills | Illinois | 60061 | United States |
| Diagnostic Rheumatology And Research, PC | Indianapolis | Indiana | 46227 | United States |
| Arthritis Treatment Center | Frederick | Maryland | 21702 | United States |
| Dartmouth-Hitchcock Medical Center | Lebanon | New Hampshire | 03756 | United States |
| The Center for Rheumatology, LLP | Albany | New York | 12206 | United States |
| Buffalo Rheumatology and Medicine, PLLC | Orchard Park | New York | 14127 | United States |
| Piedmont Rheumatology, P.A | Hickory | North Carolina | 28602 | United States |
| PMG Research of Hickory, LLC | Hickory | North Carolina | 28602 | United States |
| PMG Research of Salisbury, LLC | Salisbury | North Carolina | 28144 | United States |
| Novant Health Imaging Julian Road | Salisbury | North Carolina | 28147 | United States |
| East Penn Rheumatology Associates, PC | Bethlehem | Pennsylvania | 18015 | United States |
| Altoona Center for Clinical Research | Duncansville | Pennsylvania | 16635 | United States |
| Clinical Research Center of Reading LLP | Wyomissing | Pennsylvania | 19610 | United States |
| Palmetto Clinical Trial Services, LLC | Greenville | South Carolina | 29601 | United States |
| Arthritis Clinic | Jackson | Tennessee | 38305 | United States |
| West Tennessee Research Institute | Jackson | Tennessee | 38305 | United States |
| Rheumatology Consultants, PLLC | Knoxville | Tennessee | 37909-1907 | United States |
| Office of John P. Lavery, MD, PA | Allen | Texas | 75013 | United States |
| Baylor Research Institute Arthritis Care and Research Center | Dallas | Texas | 75231 | United States |
| The Vancouver Clinic (Drug Shipment Only) | Vancouver | Washington | 98664 | United States |
| The Vancouver Clinic, Inc, PS | Vancouver | Washington | 98664 | United States |
| 36601090 | Derived | 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. |
| 28845577 | Derived | Winthrop KL, Wouters AG, Choy EH, Soma K, Hodge JA, Nduaka CI, Biswas P, Needle E, Passador S, Mojcik CF, Rigby WF. The Safety and Immunogenicity of Live Zoster Vaccination in Patients With Rheumatoid Arthritis Before Starting Tofacitinib: A Randomized Phase II Trial. Arthritis Rheumatol. 2017 Oct;69(10):1969-1977. doi: 10.1002/art.40187. Epub 2017 Sep 6. |
Following administration of zoster vaccine to RA participants receiving background methotrexate, participants received tofacitinib 5 mg twice a day orally for up to 12 weeks. |
| COMPLETED |
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| NOT COMPLETED |
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The baseline analysis population included all randomized participants who received at least 1 dose of study drug (tofacitinib or placebo).
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| ID | Title | Description |
|---|---|---|
| BG000 | Placebo Twice a Day | Following administration of zoster vaccine, participants with Rheumatoid Arthritis (RA) on background methotrexate received placebo matched tofacitinib tablets twice a day orally for up to 12 weeks. |
| BG001 | Tofacitinib 5 mg Twice a Day | Following administration of zoster vaccine to RA participants receiving background methotrexate, participants received tofacitinib 5 mg twice a day orally for up to 12 weeks. |
| 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, Continuous | Mean | Standard Deviation | years |
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| 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 | Fold Change From Baseline in Varicella Zoster Virus (VZV)-Specific Immunoglobulin G (IgG) Levels at Week 4 | VZV-specific IgG levels as measured by enzyme-linked immunosorbent assay (ELISA). | The evaluable immunogenicity analysis population included randomized participants who had at least 1 dose of study drug (tofacitinib or placebo) and who complied closely with protocol eligibility criteria, visit windows for study procedures, had valid assay results at the primary visits and no major protocol deviations. | Posted | Geometric Mean | 80% Confidence Interval | fold rise | Baseline (pre-vaccination; Day -14), Week 4 (6 weeks post-vaccination) |
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| Secondary | Fold Change From Baseline in VZV-Specific IgG Levels at Day 1 and Week 12 | The evaluable immunogenicity analysis population included randomized participants who had at least 1 dose of study drug (tofacitinib or placebo) and who complied closely with protocol eligibility criteria, visit windows for study procedures, had valid assay results at the primary visits and no major protocol deviations. | Posted | Geometric Mean | 80% Confidence Interval | fold rise | Baseline (pre-vaccination; Day -14), Day 1 (2 weeks post-vaccination), Week 12 (14 weeks post-vaccination) |
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| Secondary | Absolute Values in VZV-Specific IgG Levels at Day 1, Week 4 and Week 12 | The absolute geometric mean titer (GMT) of VZV-specific IgG levels was calculated from logarithmically transformed assay values. | The evaluable immunogenicity analysis population included randomized participants who had at least 1 dose of study drug (tofacitinib or placebo) and who complied closely with protocol eligibility criteria, visit windows for study procedures, had valid assay results at the primary visits and no major protocol deviations. | Posted | Geometric Mean | 80% Confidence Interval | [gp]ELISA units/mL | Day 1 (2 weeks post-vaccination), Week 4 (6 weeks post-vaccination), Week 12 (14 weeks post-vaccination) |
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| Secondary | Percentage of Participants With >=1.5 Fold Change in VZV-Specific IgG Levels Day 1, Week 4 and Week 12 | VZV-specific IgG levels as measured by ELISA. A ratio greater than or equal to (>=)1.5 was defined as a responder. | The evaluable immunogenicity analysis population included randomized participants who had at least 1 dose of study drug (tofacitinib or placebo) and who complied closely with protocol eligibility criteria, visit windows for study procedures, had valid assay results at the primary visits and no major protocol deviations. | Posted | Number | 80% Confidence Interval | percentage of participants | Day 1 (2 weeks post-vaccination), Week 4 (6 weeks post-vaccination), Week 12 (14 weeks post-vaccination) |
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| Other Pre-specified | Number of Participants With Treatment-Emergent Adverse Events (AEs) or Serious Adverse Events (SAEs) | An AE was any untoward medical occurrence in a participant who received study drug. An SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. Treatment-emergent are events between first dose of study drug and up to Week 16 that were absent before treatment or that worsened relative to pre-treatment state. AEs included both SAEs and non-SAEs. | The safety analysis population included randomized participants who received at least 1 dose of the study drug (tofacitinib or placebo). | Posted | Number | participants | Baseline up to Week 16 |
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| Other Pre-specified | Number of Participants With Zoster Vaccine-Related AEs by System Organ Class | Zoster vaccine-related AEs included General Disorders and Administration Site Conditions (injection site erythema, pain, pruritis, rash, swelling; vaccination site erythema, pruritus, rash), Infections and Infestations (disseminated herpes zoster), and Musculoskeletal and Connective Tissue Disorders (myalgia). All zoster vaccine-related AEs were mild, except for the herpes zoster AE classified under Infections and Infestations, which was moderate in severity. | The safety analysis population included randomized participants who received at least 1 dose of the study drug (tofacitinib or placebo). | Posted | Number | participants | Baseline up to Week 16 |
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| Other Pre-specified | Number of Participants With Clinical Herpes Zoster Events by Severity | Clinical herpes is manifested as mild, moderate, or severe disseminated herpes zoster. | The safety analysis population included randomized participants who received at least 1 dose of the study drug (tofacitinib or placebo). | Posted | Number | participants | Baseline up to Week 16 |
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| Other Pre-specified | Number of Participants With Clinically Significant Abnormal Laboratory Parameters | Participants with the following abnormalities were discontinued from the study: 2 sequential absolute neutrophil counts (ANC) <1000/mm^3; 2 sequential hemoglobin values <8.0 g/dL or decreases of >30% from baseline value; 2 sequential absolute lymphocyte count <500/mm^3; 2 sequential platelet counts <75,000/mm^3; 2 sequential alanine aminotransferase (ALT) or aspartate aminotransferase (AST) elevations >=3 times the upper limit of normal (X ULN) with a total bilirubin value >=2X ULN, elevated international normalized ratio (INR), or accompanied by signs/symptoms consistent with hepatic injury; 2 sequential ALT or AST elevations >=5X ULN regardless of total bilirubin or accompanying symptoms; confirmed increases in serum creatinine (SCr) >50% over the average of screening and baseline values; a confirmed positive urine pregnancy test or refusal to use appropriate contraception in a woman of childbearing potential. | The safety analysis population included randomized participants who received at least 1 dose of the study drug (tofacitinib or placebo). | Posted | Number | participants | Baseline up to Week 16 |
|
Baseline up to Week 16
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
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 Twice a Day | Following administration of zoster vaccine, participants with Rheumatoid Arthritis (RA) on background methotrexate received placebo matched tofacitinib tablets twice a day orally for up to 12 weeks. | 0 | 57 | 9 | 57 | ||
| EG001 | Tofacitinib 5 mg Twice a Day | Following administration of zoster vaccine to RA participants receiving background methotrexate, participants received tofacitinib 5 mg twice a day orally for up to 12 weeks. | 3 | 55 | 6 | 55 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Bile duct stone | Hepatobiliary disorders | MedDRA 18.0 | Non-systematic Assessment | Bile duct stone and cholangitis occurred in the same subject. |
|
| Cholangitis | Hepatobiliary disorders | MedDRA 18.0 | Non-systematic Assessment | Bile duct stone and cholangitis occurred in the same subject. |
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| Bronchitis | Infections and infestations | MedDRA 18.0 | Non-systematic Assessment |
| |
| Herpes zoster disseminated | Infections and infestations | MedDRA 18.0 | Non-systematic Assessment | adjudicated AE term "vaccine dissemination VZV" |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA 18.0 | Non-systematic Assessment |
| |
| Rheumatoid arthritis | Musculoskeletal and connective tissue disorders | MedDRA 18.0 | 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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| Participants |
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| Units | Counts |
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Following administration of zoster vaccine to RA participants receiving background methotrexate, participants received tofacitinib 5 mg twice a day orally for up to 12 weeks.
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