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| ID | Type | Description | Link |
|---|---|---|---|
| 2018-004175-12 | EudraCT Number |
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Assessment of PF-06700841 in participants with moderate to severe active, generalized Systemic Lupus Erythematosus (SLE) that have inadequate response to standard of care.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Placebo | Placebo Comparator | Placebo |
|
| PF-06700841 15 mg | Experimental | PF-06700841 15 mg |
|
| PF-06700841 30 mg | Experimental | PF-06700841 30 mg |
|
| PF-06700841 45 mg | Experimental | PF-06700841 45 mg |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Placebo | Drug | Placebo |
| |
| PF-06700841 15 mg |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Participants Achieving SLE Responder Index (SRI) Change of 4 (SRI-4) at Week 52 | SRI-4 components included Systemic Lupus Erythematosus Disease Activity Index 2000 (SLEDAI-2K), British Isles Lupus Assessment Group (BILAG) 2004 and Physician's Global Assessment (PhGA). Participants were classified as SRI-4 responders, if they met all of the following criteria compared with baseline: 1) greater than or equal to (>=) 4 point reduction in SLEDAI-2K score; 2) no new BILAG A organ domain score or 2 new BILAG B organ domain scores; 3) no worsening (less than [<] 0.3 point increase) in PhGA score. SLEDAI-2K: assesses improvement in disease activity (range: 0 to 105; higher score = higher severity). BILAG: assesses disease extent, severity in individual organ system (range: A [severe] to E [no disease]; higher score = less severity). PhGA: assesses worsening in participant's general health status (range: 0 [none] to 3 [severe]; higher score = higher severity). | Week 52 |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Participants Achieving British Isles Lupus Assessment Group-Based Composite Lupus Assessment (BICLA) at Week 52 | BICLA included: BILAG-2004, SLEDAI-2K and PhGA. Participants were classified as responders, if they met all the following criteria: BILAG-2004 improvement (all A scores at baseline improved to B/C/D and all B scores improved to C or D); no worsening in disease activity (no new BILAG-2004 A scores or =<1 new B score); no worsening of total SLEDAI-2K score; no significant deterioration (<10 percent [%] worsening) in analogue PhGA. SLEDAI-2K: assesses improvement in disease activity (range: 0 to 105; higher score = higher severity). BILAG: assesses disease extent, severity in individual organ system (range: A [severe] to E [no disease]; higher score = less severity). PhGA: assesses worsening in participant's general health status (range: 0 [none] to 3 [severe]; higher score = higher severity). |
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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 |
|---|---|---|---|---|---|---|
| UAB Department of Medicine Clinical Research Enterprise | Birmingham | Alabama | 35205 | United States | ||
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 33687069 | Derived | Hannon CW, McCourt C, Lima HC, Chen S, Bennett C. Interventions for cutaneous disease in systemic lupus erythematosus. Cochrane Database Syst Rev. 2021 Mar 9;3(3):CD007478. doi: 10.1002/14651858.CD007478.pub2. |
| Label | URL |
|---|---|
| To obtain contact information for a study center near you, click here. | View source |
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Pfizer will provide access to individual de-identified participant data and related study documents (e.g. protocol, Statistical Analysis Plan (SAP), Clinical Study Report (CSR)) upon request from qualified researchers, and subject to certain criteria, conditions, and exceptions. Further details on Pfizer's data sharing criteria and process for requesting access can be found at: https://www.pfizer.com/science/clinical\_trials/trial\_data\_and\_results/data\_requests.
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A total of 350 participants with active systemic lupus erythematosus (SLE) were enrolled and randomized in the study.
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| ID | Title | Description |
|---|---|---|
| FG000 | Placebo | Participants were randomized to receive placebo matched to PF-06700841 once daily (QD) for 52 weeks. Participants were followed up for 4 weeks after last dose. |
| FG001 | PF-06700841 15 mg |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Treatment Period (52 Weeks) |
|
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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 | Jun 15, 2023 | Jun 28, 2024 |
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| Drug |
PF-06700841 15 mg |
|
| PF-06700841 30 mg | Drug | PF-06700841 30 mg |
|
| PF-06700841 45 mg | Drug | PF-06700841 45 mg |
|
| Week 52 |
| Percentage of Participants Achieving Lupus Low Disease Activity State (LLDAS) at Week 52 | LLDAS was defined as SLE disease activity index (SLEDAI-2k <=4, with no activity in major organ systems [renal, central nervous system, cardiopulmonary, vasculitis, fever]) and no haemolytic anaemia or gastrointestinal activity; no new lupus disease activity compared with the previous assessment; a Safety of Estrogens in Lupus Erythematosus National Assessment (SELENA)-SLEDAI PhGA (scale 0-3; higher scores = higher severity) <=1; a current prednisolone (or equivalent) dose <=7.5 milligram per day (mg/daily); and well tolerated standard maintenance doses of immunosuppressive drugs and approved biological agents. | Week 52 |
| Percentage of Participants Achieving a Reduction in Prednisone (or Equivalent) Dose to <=7.5 mg/Day and Sustained for 12 Weeks Prior to Week 52 in Participants on Prednisone >7.5 mg/Day (or Equivalent) at Baseline | In this outcome measure data is reported for participants who achieved a reduction in prednisone (or equivalent) dose to <=7.5 mg/day and sustained for 12 Weeks prior at Week 52 and they also sustained this dose reduction for 12 weeks prior to Week 52 (Week 40 to Week 52). | Week 52 for achieving reduction in dose along with Week 40 to Week 52 for sustained dosing |
| Percentage of Participants Achieving a SRI-4 Response With Prednisone Dose Reduced to <=7.5 mg/Day and Sustained for 12 Weeks at Week 52 in Participants on Prednisone >7.5 mg/Day (or Equivalent) at Baseline | In this outcome measure data is reported for participants who achieved a reduction in SRI-4 response with prednisone dose reduced to <=7.5 mg/day and sustained for 12 weeks at Week 52. | 12 Weeks prior at Week 52 (Week 40 to Week 52) |
| Percentage of Participants With >= 50% Reduction in Cutaneous Lupus Erythematosus Disease Area and Severity Index Activity (CLASI-A) Score at Week 52 in Participants With Baseline CLASI-A Score >=10 | CLASI is an validated measurement instrument for lupus erythematosus developed for use in clinical studies that consists of separate scores for the activity of the disease (CLASI-A). The CLASI activity score is calculated on the basis of erythema, scale/hyperkeratosis, mucous membrane involvement, acute hair loss and non-scarring alopecia. The CLASI activity score ranges from 0-70, with higher scores indicating more severe skin disease. Severity categories based on the CLASI activity score are as follows: mild (0-9), moderate (10-20), and severe (21-70). | Week 52 |
| Change From Baseline in Total Scores of Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-F) at Week 52 | The FACIT-F Scale is a participant completed questionnaire consisting of 13 items that assess fatigue. Participants responded to each item on a 5-point scale based on their experience of fatigue during the past 7 days (0 = not at all; 1 = a little bit; 2 =somewhat; 3 = quite a bit; 4 = very much). Instrument scoring yielded a range from 0 to 52 (negatively worded items were reversed during analysis), with higher scores representing better participant status (less fatigue). | Baseline, Week 52 |
| Change From Baseline in Physical Health Domain Scores of Lupus Quality of Life (LupusQoL) at Week 52 | The LupusQoL questionnaire is a validated questionnaire used to evaluate SLE -specific concepts of SLE as reported by participants. It consists of 34 items in 8 different domains: physical health, emotional health, body image, pain, planning, fatigue, intimate relationship, and burden to others; measured on a 5-point scale ranging from 0 (not at all) to 4 (very much). The individual domain scores are transformed to a 0 to 100 scale wherein higher scores indicate better quality of life. Physical health domain score of LupusQoL had score range from 0 to 100, where higher scores = better quality of life. | Baseline, Week 52 |
| Change From Baseline in Emotional Health Domain Scores of LupusQoL at Week 52 | The LupusQoL questionnaire is a validated questionnaire used to evaluate SLE -specific concepts of SLE as reported by participants. It consists of 34 items in 8 different domains: physical health, emotional health, body image, pain, planning, fatigue, intimate relationship, and burden to others measured on a 5-point scale ranging from 0 (not at all) to 4 (very much). The individual domain scores are transformed to a 0 to 100 scale wherein higher scores indicate better quality of life. Emotional health domain score of LupusQoL had score range from 0 to 100, where higher scores = better quality of life. | Baseline, Week 52 |
| Change From Baseline in Body Image Domain Scores of LupusQoL at Week 52 | The LupusQoL questionnaire is a validated questionnaire used to evaluate SLE -specific concepts of SLE as reported by participants. It consists of 34 items in 8 different domains: physical health, emotional health, body image, pain, planning, fatigue, intimate relationship, and burden to others measured on a 5-point scale ranging from 0 (not at all) to 4 (very much). The individual domain scores are transformed to a 0 to 100 scale wherein higher scores indicate better quality of life. Body image domain score of LupusQoL had score range from 0 to 100, where higher scores = better quality of life. | Baseline, Week 52 |
| Change From Baseline in Pain Domain Scores of LupusQoL at Week 52 | The LupusQoL questionnaire is a validated questionnaire used to evaluate SLE -specific concepts of SLE as reported by participants. It consists of 34 items in 8 different domains: physical health, emotional health, body image, pain, planning, fatigue, intimate relationship, and burden to others measured on a 5-point scale ranging from 0 (not at all) to 4 (very much). The individual domain scores are transformed to a 0 to 100 scale wherein higher scores indicate better quality of life. Pain domain score of LupusQoL had score range from 0 to 100, where higher scores = better quality of life. | Baseline, Week 52 |
| Change From Baseline in Planning Domain Scores of LupusQoL at Week 52 | The LupusQoL questionnaire is a validated questionnaire used to evaluate SLE -specific concepts of SLE as reported by participants. It consists of 34 items in 8 different domains: physical health, emotional health, body image, pain, planning, fatigue, intimate relationship, and burden to others measured on a 5-point scale ranging from 0 (not at all) to 4 (very much). The individual domain scores are transformed to a 0 to 100 scale wherein higher scores indicate better quality of life. Planning domain score of LupusQoL had score range from 0 to 100, where higher scores = better quality of life. | Baseline, Week 52 |
| Change From Baseline in Fatigue Domain Scores of LupusQoL at Week 52 | The LupusQoL questionnaire is a validated questionnaire used to evaluate SLE -specific concepts of SLE as reported by participants. It consists of 34 items in 8 different domains: physical health, emotional health, body image, pain, planning, fatigue, intimate relationship, and burden to others measured on a 5-point scale ranging from 0 (not at all) to 4 (very much). The individual domain scores are transformed to a 0 to 100 scale wherein higher scores indicate better quality of life. Fatigue domain score of LupusQoL had score range from 0 to 100, where higher scores = better quality of life. | Baseline, Week 52 |
| Change From Baseline in Intimate Relationship Domain Scores of LupusQoL at Week 52 | The LupusQoL questionnaire is a validated questionnaire used to evaluate SLE -specific concepts of SLE as reported by participants. It consists of 34 items in 8 different domains: physical health, emotional health, body image, pain, planning, fatigue, intimate relationship, and burden to others measured on a 5-point scale ranging from 0 (not at all) to 4 (very much). The individual domain scores are transformed to a 0 to 100 scale wherein higher scores indicate better quality of life. Intimate relationship domain score of LupusQoL had score range from 0 to 100, where higher scores = better quality of life. | Baseline, Week 52 |
| Change From Baseline in Burden to Others Domain Scores of LupusQoL at Week 52 | The LupusQoL questionnaire is a validated questionnaire used to evaluate SLE -specific concepts of SLE as reported by participants. It consists of 34 items in 8 different domains: physical health, emotional health, body image, pain, planning, fatigue, intimate relationship, and burden to others measured on a 5-point scale ranging from 0 (not at all) to 4 (very much). The individual domain scores are transformed to a 0 to 100 scale wherein higher scores indicate better quality of life. Burden to others domain score of LupusQoL had score range from 0 to 100, where higher scores = better quality of life. | Baseline, Week 52 |
| Incidence Rate of Severe Flare Event | Incidence rate was defined as the number of new events per 100 person-years. | Week 52 |
| Number of Participants With Treatment-Emergent Adverse Events (AE) | An AE was any untoward medical occurrence in a participant who received study intervention without regard to possibility of causal relationship. TEAEs are events from first dose of study intervention to 4 weeks after last dose of study intervention that were absent before treatment or that worsened relative to pre-treatment state. 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. AEs included both SAEs and all non-SAEs. | Day 1 of dosing up to 4 weeks after last dose of study drug (maximum treatment was up to 52 weeks, follow-up up to 56 weeks) |
| Number of Participants With Serious Adverse Events (SAEs) | An AE was any untoward medical occurrence in a participant who received study intervention without regard to possibility of causal relationship. 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. | Day 1 of dosing up to 4 weeks after last dose of study drug (maximum treatment was up to 52 weeks, follow-up up to 56 weeks) |
| Number of Participants With Adverse Events Leading to Discontinuation From Study | An AE was any untoward medical occurrence in a participant who received study intervention without regard to possibility of causal relationship. In this outcome measure, participants with adverse events leading to discontinuation from study were reported. | Day 1 of dosing up to 4 weeks after last dose of study drug (maximum treatment was up to 52 weeks, follow-up up to 56 weeks) |
| Number of Participants With Clinically Significant Vital Signs Abnormalities | Vital signs included blood pressure, pulse rate, respiratory rate, and temperature. Clinical significance in vital signs abnormalities was judged by investigator. | Day 1 of dosing up to 4 weeks after last dose of study drug (maximum treatment was up to 52 weeks, follow-up up to 56 weeks) |
| Number of Participants With Clinically Significant Electrocardiogram (ECG) Abnormalities | Clinical significance in ECG abnormalities was judged by investigator. | Day 1 of dosing up to 4 weeks after last dose of study drug (maximum treatment was up to 52 weeks, follow-up up to 56 weeks) |
| Number of Participants With Laboratory Test Abnormalities | Hematology (Hemoglobin[hgb], hematocrit, erythrocytes[ery]:<0.8*lower limit of normal[LLN];reticulocytes, reticulocytes/ery:<0.5*LLN,>1.5*upper LN[ULN];ery mean corpuscular volume[EMC], EMC hgb:<0.9*LLN,>1.5*ULN;EMC hgb concentration:<0.9* LLN;platelet:<0.5*LLN;leukocytes[leu]:<0.6*LLN,>1.5*ULN;lymphocytes, lymphocytes/leu, neutrophils, neutrophils/leu:<0.8* LLN,>1.2*ULN;basophils, basophils/leu, eosinophils, eosinophils/leu, monocytes, monocytes/leu:>1.2*ULN;activated partial thromboplastin time[PTT], PTT, prothrombin time:>1.1*ULN);Clinical chemistry (Total/direct/indirect bilirubin, glucose-fasting:>1.5*ULN; aspartate aminotransferase[AT], alanine AT:>3.0*ULN; protein, albumin, HDL cholesterol:<0.8*LLN;urea nitrogen, creatinine, triglyceride, cholesterol:>1.3*ULN;urate, LDL cholesterol:>1.2*ULN;potassium:<0.9*LLN,>1.1*ULN;calcium, bicarbonate:<0.9*LLN;creatine kinase:>2.0*ULN);Urinalysis (pH<4.5;glucose, protein, hgb, ketones, nitrite, leu esterase, granular/hyaline/WBCs casts:>1). | Day 1 of dosing up to 4 weeks after last dose of study drug (maximum treatment was up to 52 weeks, follow-up up to 56 weeks) |
| The Kirklin Clinic |
| Birmingham |
| Alabama |
| 35233 |
| United States |
| UAB Hospital Department of Pharmacy | Birmingham | Alabama | 35249 | United States |
| UAB Hospital-Clinical Research Unit (CRU) | Birmingham | Alabama | 35249 | United States |
| The University of Alabama at Birmingham | Birmingham | Alabama | 35294 | United States |
| UAB Department of Medicine Clinical Research Enterprise | Birmingham | Alabama | 35294 | United States |
| St. Joseph Heritage Healthcare | Fullerton | California | 92835 | United States |
| Advanced Medical Research, LLC | La Palma | California | 90623 | United States |
| Arthritis and Osteoporosis Medical Center | La Palma | California | 90623 | United States |
| Desert Medical Advances | Palm Desert | California | 92260-9368 | United States |
| East Bay Rheumatology Medical Group, Inc. | San Leandro | California | 94578 | United States |
| Millennium Clinical Trials | Thousand Oaks | California | 91360 | United States |
| Inland Rheumatology and Osteoporosis Medical Group | Upland | California | 91786 | United States |
| Inland Rheumatology Clinical Trials, Inc. | Upland | California | 91786 | United States |
| New England Research Associates, LLC | Bridgeport | Connecticut | 06606 | United States |
| New England Research Associates | Bridgeport | Connecticut | 06606 | United States |
| Stamford Therapeutics Consortium | Stamford | Connecticut | 06905 | United States |
| Clinical Research of West Florida | Clearwater | Florida | 33765 | United States |
| Private Practice of Robert W. Levin | Clearwater | Florida | 33765 | United States |
| SIMEDHealth, LLC Attn: Rheumatology | Gainesville | Florida | 32607 | United States |
| SIMEDHealth, LLC | Gainesville | Florida | 32607 | United States |
| Omega Research MetroWest, LLC | Orlando | Florida | 32808 | United States |
| Akumin, Inc | Palm Harbor | Florida | 34685 | United States |
| Akumin Inc | St. Petersburg | Florida | 33703 | United States |
| West Broward Rheumatology Associates, Inc | Tamarac | Florida | 33321 | United States |
| Akumin Inc. | Tampa | Florida | 33603 | United States |
| Rose Radiology dba Akumin Inc. | Tampa | Florida | 33603 | United States |
| Clinical Research of West Florida | Tampa | Florida | 33606 | United States |
| AdventHealth Tampa | Tampa | Florida | 33613 | United States |
| Jefrey D. Lieberman, M.D., P.C. | Decatur | Georgia | 30033 | United States |
| Atlanta Research Center for Rheumatology | Marietta | Georgia | 30060 | United States |
| Institute of Arthritis Research | Idaho Falls | Idaho | 83404 | United States |
| Investigational Drug Services University of Kansas Hospital | Kansas City | Kansas | 66103 | United States |
| The University of Kansas Hospital | Kansas City | Kansas | 66160 | United States |
| University of Kansas Medical Center | Kansas City | Kansas | 66160 | United States |
| Ochsner Clinic Foundation, Baton Rouge | Baton Rouge | Louisiana | 70836 | United States |
| University of Michigan Brighton Center for Specialty Care | Brighton | Michigan | 48116 | United States |
| Innovative health Research | Las Vegas | Nevada | 89128 | United States |
| NYU Langone Ambulatory Care Brooklyn Heights | Brooklyn | New York | 11201 | United States |
| St. Lawrence Health System | Canton | New York | 13617 | United States |
| Feinstein Institute for Medical Research | Manhasset | New York | 11030 | United States |
| Northshore University Hospital | Manhasset | New York | 11030 | United States |
| Columbia University Medical Center. | New York | New York | 10032 | United States |
| Irving Institute for Clinical and Transitional Research | New York | New York | 10032 | United States |
| St. Lawrence Health System | Potsdam | New York | 13676 | United States |
| Joint and Muscle Research Institute | Charlotte | North Carolina | 28204 | United States |
| Arthritis & Rheumatology Center of Oklahoma PLLC | Oklahoma City | Oklahoma | 73102 | United States |
| West Tennessee Research Institute | Jackson | Tennessee | 38305 | United States |
| Gupta, Ramesh C MD | Memphis | Tennessee | 38119-5214 | United States |
| Tekton Research | Austin | Texas | 78745 | United States |
| Accurate Clinical Management, LLC | Baytown | Texas | 77521 | United States |
| Rheumatic Disease Clinical Research Center, LLC | Houston | Texas | 77004 | United States |
| Accurate Clinical Research | Houston | Texas | 77089 | United States |
| Arthritis Clinic of Central Texas | San Marcos | Texas | 78666 | United States |
| Arthritis Northwest, PLLC | Spokane | Washington | 99204 | United States |
| Centro de Investigaciones Medicas Tucuman | San Miguel de Tucumán | Tucumán Province | T4000AXL | Argentina |
| Optimus Clinical Research | Kogarah | New South Wales | 2217 | Australia |
| Emeritus Research | Camberwell | Victoria | 3124 | Australia |
| UZ Leuven | Leuven | 3000 | Belgium |
| Ziekenhuisnetwerk Antwerpen Jan Palfijn (ZNA Jan Palfijn) | Merksem | 2170 | Belgium |
| DCC Sveti Georgi EOOD | Plovdiv | 4000 | Bulgaria |
| MHAT Plovdiv AD | Plovdiv | 4000 | Bulgaria |
| Umhat Kanev Ad | Rousse | 7002 | Bulgaria |
| UMHAT "Sv.Ivan Rilski" EAD | Sofia | 1431 | Bulgaria |
| UMHAT "Sv. Ivan Rilski" EAD | Sofia | 1432 | Bulgaria |
| Centre intégré de santé et de services sociaux du Bas-Saint-Laurent | Rimouski | Quebec | G5L 5T1 | Canada |
| Centre de Recherche Musculo-Squelettique | Trois-Rivières | Quebec | G8Z 1Y2 | Canada |
| Anhui Provincial Hospital | Hefei | Anhui | 230001 | China |
| The Second Xiangya Hospital of Central South University | Changsha | Hunan | 410011 | China |
| The First Affiliated Hospital of Soochow University | Suzhou | Jiangsu | 215006 | China |
| Tianjin Medical University General Hospital | Tianjin | Tianjin Municipality | 300052 | China |
| Peking Union Medical College Hospital | Beijing | 100730 | China |
| Ruijin Hospital- Shanghai Jiaotong University School of Medicine | Shanghai | 200025 | China |
| Fudan University Hua Shan Hospital | Shanghai | 200040 | China |
| Hospital Pablo Tobon Uribe | MedellÃn | Antioquia | 050034 | Colombia |
| Centro Integral de ReumatologÃa del Caribe S.A.S - CIRCARIBE S.A.S | Barranquilla | Atlántico | 080002 | Colombia |
| Bluecare Salud S.A.S Sede Centro Médico Integral Chicó MedPlus CRI | Bogota | Cundinamarca | 110221 | Colombia |
| Centro de Investigación en ReumatologÃa y Especialidades Médicas SAS - CIREEM SAS | Bogotá | Cundinamarca | 110221 | Colombia |
| Medicity S.A.S. | Bucaramanga | Santander Department | 680003 | Colombia |
| Vseobecna fakultni nemocnice v Praze | Prague | 128 08 | Czechia |
| Nemocnicni lekarna VFN | Prague | 12802 | Czechia |
| Revmatologicky ustav | Prague | 12850 | Czechia |
| Hôpital Pitié Salpêtrière, Centre des Maladies Auto-immunes | Paris | 75013 | France |
| Hôpital Cochin | Paris | 75014 | France |
| CHU de Bordeaux, Groupe Hospitalier Sud, Hôpital Haut Lévèque | Pessac | 33604 | France |
| Medizinische Hochschule Hannover | Hanover | 30625 | Germany |
| Universitätsklinikum Schleswig Holstein - Campus Lübeck | Lübeck | 23538 | Germany |
| University General Hospital of Heraklion | Heraklion | Crete | 71110 | Greece |
| Laiko General Hospital, University of Athens | Athens | 11527 | Greece |
| University Hospital ATTIKON | Haidari | 12462 | Greece |
| Tuen Mun Hospital | Hong Kong | Hong Kong |
| Qualiclinic Kft. | Budapest | 1036 | Hungary |
| Debreceni Egyetem Klinikai Kozpont | Debrecen | 4032 | Hungary |
| Békés Vármegyei Központi Kórház | Gyula | 5700 | Hungary |
| Fondazione IRCCS Policlinico S.Matteo | Pavia | 27100 | Italy |
| National Hospital Organization Asahikawa Medical Center | Asahikawa | Hokkaido | 070-8644 | Japan |
| Hokkaido University Hospital | Sapporo | Hokkaido | 060-8648 | Japan |
| Tohoku University Hospital | Sendai | Miyagi | 980-8574 | Japan |
| Sasebo Chuo Hospital | Sasebo | Nagasaki | 857-1195 | Japan |
| Shinkenko clinic | Naha | Okinawa | 900-0015 | Japan |
| St. Luke's International Hospital | Chuo-ku | Tokyo | 104-8560 | Japan |
| National Hospital Organization Chiba-East Hospital | Chiba | 260-8712 | Japan |
| National Hospital Organization Kyushu Medical Center | Fukuoka | 810-8563 | Japan |
| Hiroshima University Hospital | Hiroshima | 734-8551 | Japan |
| CITER Centro de Investigación y Tratamiento de las Enfermedades Reumáticas S.A. de C.V. | Mexico City | Cuauhtémoc | 06700 | Mexico |
| Morales Vargas Centro de Investigación S.C. | León | Guanajuato | 37000 | Mexico |
| Investigación Biomédica para el Desarrollo de Fármacos S.A. de C.V | Guadalajara | Jalisco | 45070 | Mexico |
| Investigación Biomédica para el Desarrollo de Fármacos S.A. de C.V | Zapopan | Jalisco | 45070 | Mexico |
| Investigación Biomédica para el Desarrollo de Fármacos S.A. de C.V | Zapopan | Jalisco | C.P. 45070 | Mexico |
| Instituto Nacional de Ciencias Médicas y Nutrición Salvador Zubirán | Mexico City | Tlalpan | 14080 | Mexico |
| Centro Peninsular de Investigación ClÃnica S.C.P. | Mérida | Yucatán | 97000 | Mexico |
| Investigación y Biomedicina de Chihuahua, Sociedad Civil | Chihuahua City | 31000 | Mexico |
| Investigación Biomédica para el Desarrollo de Fármacos S.A. de C.V | Guadalajara | 45070 | Mexico |
| CINTRE Centro de Investigación y Tratamiento Reumatológico S.C. | Mexico City | 11850 | Mexico |
| Centrum Wsparcia Badan Klinicznych | Warsaw | Masovian Voivodeship | 02-637 | Poland |
| Stanislaw Sierakowski Centrum Miriada | Bialystok | 15-297 | Poland |
| Szpital Biziela | Bydgoszcz | 85-168 | Poland |
| Zespol Poradni Specjalistycznych Reumed, Onyksowa Filia nr 2 | Lublin | 20-582 | Poland |
| NZOZ "Lecznica Mak-Med" s.c. | Nadarzyn | 05-830 | Poland |
| Centrum Medyczne MEDENS S.C. Grupowa Praktyka Lekarska | Sosnowiec | 41-200 | Poland |
| Narodowy Instytutu Geriatrii, Reumatologii i Rehabilitacji | Warsaw | 02-637 | Poland |
| Mazowieckie Centrum Reumatologii i Osteoporozy M. Przygodzka Spolka jawna | Warsaw | 04-030 | Poland |
| Hospital Garcia de Orta, E.P.E | Almada | 2805-267 | Portugal |
| Hospital Professor Doutor Fernando da Fonseca, E.P.E | Amadora | 2720-276 | Portugal |
| Unidade Local de Saude do Alto Minho, E.P.E. | Ponte de Lima | 4990-078 | Portugal |
| Centro Hospitalar Universitario do Porto, E.P.E | Porto | 4099-001 | Portugal |
| SC Centrul Medical de Diagnostic si Tratament Ambulator Neomed SRL | Brasov | JUD. Brasov | 500283 | Romania |
| Spitalul Clinic Judetean de Urgenta Cluj-Napoca | Cluj-Napoca | JUD. CLUJ | 400006 | Romania |
| S.C. Euroclinic Hospital S.A | Bucharest | Sector 1 | 014461 | Romania |
| Spitalul Clinic Sf. Maria | Bucharest | 011172 | Romania |
| Institut za Reumatologiju | Belgrade | 11000 | Serbia |
| Klinicki Centar Srbije, Klinika za alergologiju i imunologiju | Belgrade | 11000 | Serbia |
| Vojnomedicinska akademija, Klinika za reumatologiju | Belgrade | 11000 | Serbia |
| Institut Niska Banja, Klinika za Reumatologiju | Niška Banja | 18205 | Serbia |
| Ajou University Hospital | Suwon | Gyeonggi-do | 16499 | South Korea |
| The Catholic Univ. of Korea Seoul St. Mary's Hospital | Seocho-gu | Seoul | 06591 | South Korea |
| Kyungpook National University Hospital (KNUH) | Daegu | 41944 | South Korea |
| Hospital do Meixoeiro | Vigo | Pontevedra | 36200 | Spain |
| Complexo Hospitalario Universitario A Coruna | A Coruña | 15006 | Spain |
| Hospital Germans Trias i Pujol | Badalona | 08916 | Spain |
| Clinica Sagrada Familia | Barcelona | 08022 | Spain |
| Hospital Universitario Vall d'Hebron | Barcelona | 08035 | Spain |
| Hospital Quiron Infanta Luisa | Seville | 41010 | Spain |
| China Medical University Hospital | Taichung | Taiwan (r.o.c) | 40447 | Taiwan |
| Kaohsiung Veterans General Hospital | Kaohsiung City | 81362 | Taiwan |
| Chung Shan Medical University Hospital | Taichung | 40201 | Taiwan |
| China Medical University Hospital | Taichung | 40447 | Taiwan |
| Taichung Veterans General Hospital | Taichung | 40705 | Taiwan |
| National Taiwan University Hospital | Taipei | 100 | Taiwan |
| Taipei Veterans General Hospital | Taipei | 11217 | Taiwan |
| Chang Gung Memorial Hospital Linkou Branch | Taoyuan City | 333 | Taiwan |
| State Institution National Scientific Center "M.D. Strazhesko Institute of Cardiology" of National | Kyiv | 03680 | Ukraine |
| State Institution National Scientific Center "M.D. Strazhesko Institute of Cardiology" | Kyiv | 03680 | Ukraine |
| Communal non-profitable enterprise "Lviv City Clinical Hospital #4" | Lviv | 79011 | Ukraine |
| Multifield Medical Center of Odesa National Medical University | Odesa | 65000 | Ukraine |
| Multifield Medical Center of Odessa National Medical University | Odesa | 65000 | Ukraine |
| CNPE "Odesa Regional Clinical Hospital" of Odesa Regional Council | Odesa | 65025 | Ukraine |
| CNPE "Ternopil University Hospital" of Ternopil regional council, Department of Rheumatology | Ternopil | 46002 | Ukraine |
| Zakarpattia Regional Clinical Hospital n.a. A. Novak | Uzhhorod | 88000 | Ukraine |
| CNPE "Vinnytsya regional Clinical Hospital named after N.I.Pirogov Vinnytsia Regional Council" | Vinnytsia | 21028 | Ukraine |
| Southampton General Hospital | Southampton | Hampshire | SO16 6YD | United Kingdom |
| Doncaster Royal Infirmary, Doncaster and Bassetlaw Teaching Hospitals NHS Foundation Trust | Doncaster | DN2 5LT | United Kingdom |
| The Leeds Teaching Hospitals NHS Trust, Chapel Allerton Hospital | Leeds | LS7 4SA | United Kingdom |
| Guy's and St Thomas' NHS Foundation Trust Guy's Hospital | London | SE1 9RT | United Kingdom |
Participants were randomized to receive PF-06700841 15 milligrams (mg) tablets orally QD for 52 weeks. Participants were followed up for 4 weeks after last dose.
| FG002 | PF-06700841 30 mg | Participants were randomized to receive PF-06700841 30 mg tablets orally QD for 52 weeks. Participants were followed up for 4 weeks after last dose. |
| FG003 | PF-06700841 45 mg | Participants were randomized to receive PF-06700841 45 mg tablets orally QD for 52 weeks. Participants were followed up for 4 weeks after last dose. |
| COMPLETED |
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| NOT COMPLETED |
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| Follow-up Period (4 Weeks) |
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Safety analysis set included all participants who were randomly assigned to study intervention and who took at least 1 dose of study intervention.
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Placebo | Participants were randomized to receive placebo matched to PF-06700841 QD for 52 weeks. Participants were followed up for 4 weeks after last dose. |
| BG001 | PF-06700841 15 mg | Participants were randomized to receive PF-06700841 15 mg tablets orally QD for 52 weeks. Participants were followed up for 4 weeks after last dose. |
| BG002 | PF-06700841 30 mg | Participants were randomized to receive PF-06700841 30 mg tablets orally QD for 52 weeks. Participants were followed up for 4 weeks after last dose. |
| BG003 | PF-06700841 45 mg | Participants were randomized to receive PF-06700841 45 mg tablets orally QD for 52 weeks. Participants were followed up for 4 weeks after last dose. |
| BG004 | 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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| Ethnicity (NIH/OMB) | Count of Participants | Participants |
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| Race (NIH/OMB) | 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 | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
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| Primary | Percentage of Participants Achieving SLE Responder Index (SRI) Change of 4 (SRI-4) at Week 52 | SRI-4 components included Systemic Lupus Erythematosus Disease Activity Index 2000 (SLEDAI-2K), British Isles Lupus Assessment Group (BILAG) 2004 and Physician's Global Assessment (PhGA). Participants were classified as SRI-4 responders, if they met all of the following criteria compared with baseline: 1) greater than or equal to (>=) 4 point reduction in SLEDAI-2K score; 2) no new BILAG A organ domain score or 2 new BILAG B organ domain scores; 3) no worsening (less than [<] 0.3 point increase) in PhGA score. SLEDAI-2K: assesses improvement in disease activity (range: 0 to 105; higher score = higher severity). BILAG: assesses disease extent, severity in individual organ system (range: A [severe] to E [no disease]; higher score = less severity). PhGA: assesses worsening in participant's general health status (range: 0 [none] to 3 [severe]; higher score = higher severity). | Full analysis set (FAS) included all participants randomly assigned to study intervention and have received at least 1 dose of study intervention. Here "Number of Participants Analyzed" signifies participants at Week 52 with Non-Responder Imputation (NRI) and Last Observation Carried Forward from Week 48 (LOCF48) applied. | Posted | Number | 95% Confidence Interval | Percentage of participants | Week 52 |
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| Secondary | Percentage of Participants Achieving British Isles Lupus Assessment Group-Based Composite Lupus Assessment (BICLA) at Week 52 | BICLA included: BILAG-2004, SLEDAI-2K and PhGA. Participants were classified as responders, if they met all the following criteria: BILAG-2004 improvement (all A scores at baseline improved to B/C/D and all B scores improved to C or D); no worsening in disease activity (no new BILAG-2004 A scores or =<1 new B score); no worsening of total SLEDAI-2K score; no significant deterioration (<10 percent [%] worsening) in analogue PhGA. SLEDAI-2K: assesses improvement in disease activity (range: 0 to 105; higher score = higher severity). BILAG: assesses disease extent, severity in individual organ system (range: A [severe] to E [no disease]; higher score = less severity). PhGA: assesses worsening in participant's general health status (range: 0 [none] to 3 [severe]; higher score = higher severity). | FAS included all participants randomly assigned to study intervention and have received at least 1 dose of study intervention. Here "Number of Participants Analyzed" signifies participants at Week 52 with NRI and LOCF48 applied. | Posted | Number | 95% Confidence Interval | Percentage of participants | Week 52 |
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| Secondary | Percentage of Participants Achieving Lupus Low Disease Activity State (LLDAS) at Week 52 | LLDAS was defined as SLE disease activity index (SLEDAI-2k <=4, with no activity in major organ systems [renal, central nervous system, cardiopulmonary, vasculitis, fever]) and no haemolytic anaemia or gastrointestinal activity; no new lupus disease activity compared with the previous assessment; a Safety of Estrogens in Lupus Erythematosus National Assessment (SELENA)-SLEDAI PhGA (scale 0-3; higher scores = higher severity) <=1; a current prednisolone (or equivalent) dose <=7.5 milligram per day (mg/daily); and well tolerated standard maintenance doses of immunosuppressive drugs and approved biological agents. | FAS included all participants randomly assigned to study intervention and have received at least 1 dose of study intervention. Here "Number of Participants Analyzed" signifies participants at Week 52 with NRI applied. | Posted | Number | 95% Confidence Interval | Percentage of participants | Week 52 |
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| Secondary | Percentage of Participants Achieving a Reduction in Prednisone (or Equivalent) Dose to <=7.5 mg/Day and Sustained for 12 Weeks Prior to Week 52 in Participants on Prednisone >7.5 mg/Day (or Equivalent) at Baseline | In this outcome measure data is reported for participants who achieved a reduction in prednisone (or equivalent) dose to <=7.5 mg/day and sustained for 12 Weeks prior at Week 52 and they also sustained this dose reduction for 12 weeks prior to Week 52 (Week 40 to Week 52). | FAS included all participants randomly assigned to study intervention and have received at least 1 dose of study intervention. Number of participants in FAS with baseline Prednisone or equivalent >7.5 mg/day were analyzed. Here, "Number of Participants Analyzed" signifies participants at Week 52 with NRI applied. | Posted | Number | 95% Confidence Interval | Percentage of participants | Week 52 for achieving reduction in dose along with Week 40 to Week 52 for sustained dosing |
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| Secondary | Percentage of Participants Achieving a SRI-4 Response With Prednisone Dose Reduced to <=7.5 mg/Day and Sustained for 12 Weeks at Week 52 in Participants on Prednisone >7.5 mg/Day (or Equivalent) at Baseline | In this outcome measure data is reported for participants who achieved a reduction in SRI-4 response with prednisone dose reduced to <=7.5 mg/day and sustained for 12 weeks at Week 52. | FAS included all participants randomly assigned to study intervention and have received at least 1 dose of study intervention. Number of participants in FAS with baseline Prednisone or equivalent >7.5 mg/day were analyzed. Here, "Number of Participants Analyzed" signifies participants at Week 52 with NRI applied. | Posted | Number | 95% Confidence Interval | Percentage of participants | 12 Weeks prior at Week 52 (Week 40 to Week 52) |
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| Secondary | Percentage of Participants With >= 50% Reduction in Cutaneous Lupus Erythematosus Disease Area and Severity Index Activity (CLASI-A) Score at Week 52 in Participants With Baseline CLASI-A Score >=10 | CLASI is an validated measurement instrument for lupus erythematosus developed for use in clinical studies that consists of separate scores for the activity of the disease (CLASI-A). The CLASI activity score is calculated on the basis of erythema, scale/hyperkeratosis, mucous membrane involvement, acute hair loss and non-scarring alopecia. The CLASI activity score ranges from 0-70, with higher scores indicating more severe skin disease. Severity categories based on the CLASI activity score are as follows: mild (0-9), moderate (10-20), and severe (21-70). | FAS included all participants randomly assigned to study intervention and have received at least 1 dose of study intervention. Number of participants in FAS with baseline CLASI-A score >= 10 were analyzed. Here, "Number of Participants Analyzed" signifies participants at Week 52 with NRI applied. | Posted | Number | 95% Confidence Interval | Percentage of participants | Week 52 |
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| Secondary | Change From Baseline in Total Scores of Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-F) at Week 52 | The FACIT-F Scale is a participant completed questionnaire consisting of 13 items that assess fatigue. Participants responded to each item on a 5-point scale based on their experience of fatigue during the past 7 days (0 = not at all; 1 = a little bit; 2 =somewhat; 3 = quite a bit; 4 = very much). Instrument scoring yielded a range from 0 to 52 (negatively worded items were reversed during analysis), with higher scores representing better participant status (less fatigue). | FAS included all participants randomly assigned to study intervention and have received at least 1 dose of study intervention. Here, "Number of Participants Analyzed" signifies participants evaluable with observed data at Week 52. | Posted | Least Squares Mean | 95% Confidence Interval | Units on a scale | Baseline, Week 52 |
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| Secondary | Change From Baseline in Physical Health Domain Scores of Lupus Quality of Life (LupusQoL) at Week 52 | The LupusQoL questionnaire is a validated questionnaire used to evaluate SLE -specific concepts of SLE as reported by participants. It consists of 34 items in 8 different domains: physical health, emotional health, body image, pain, planning, fatigue, intimate relationship, and burden to others; measured on a 5-point scale ranging from 0 (not at all) to 4 (very much). The individual domain scores are transformed to a 0 to 100 scale wherein higher scores indicate better quality of life. Physical health domain score of LupusQoL had score range from 0 to 100, where higher scores = better quality of life. | FAS included all participants randomly assigned to study intervention and have received at least 1 dose of study intervention. Here, "Number of Participants Analyzed" signifies participants evaluable for this outcome measure with observed data at the specified visit. | Posted | Least Squares Mean | 95% Confidence Interval | Units on a scale | Baseline, Week 52 |
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| Secondary | Change From Baseline in Emotional Health Domain Scores of LupusQoL at Week 52 | The LupusQoL questionnaire is a validated questionnaire used to evaluate SLE -specific concepts of SLE as reported by participants. It consists of 34 items in 8 different domains: physical health, emotional health, body image, pain, planning, fatigue, intimate relationship, and burden to others measured on a 5-point scale ranging from 0 (not at all) to 4 (very much). The individual domain scores are transformed to a 0 to 100 scale wherein higher scores indicate better quality of life. Emotional health domain score of LupusQoL had score range from 0 to 100, where higher scores = better quality of life. | FAS included all participants randomly assigned to study intervention and have received at least 1 dose of study intervention. Here, "Number of Participants Analyzed" signifies participants evaluable for this outcome measure with observed data at the specified visit. | Posted | Least Squares Mean | 95% Confidence Interval | Units on a scale | Baseline, Week 52 |
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| Secondary | Change From Baseline in Body Image Domain Scores of LupusQoL at Week 52 | The LupusQoL questionnaire is a validated questionnaire used to evaluate SLE -specific concepts of SLE as reported by participants. It consists of 34 items in 8 different domains: physical health, emotional health, body image, pain, planning, fatigue, intimate relationship, and burden to others measured on a 5-point scale ranging from 0 (not at all) to 4 (very much). The individual domain scores are transformed to a 0 to 100 scale wherein higher scores indicate better quality of life. Body image domain score of LupusQoL had score range from 0 to 100, where higher scores = better quality of life. | FAS included all participants randomly assigned to study intervention and have received at least 1 dose of study intervention. Here, "Number of Participants Analyzed" signifies participants evaluable for this outcome measure with observed data at the specified visit. | Posted | Least Squares Mean | 95% Confidence Interval | Units on a scale | Baseline, Week 52 |
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| Secondary | Change From Baseline in Pain Domain Scores of LupusQoL at Week 52 | The LupusQoL questionnaire is a validated questionnaire used to evaluate SLE -specific concepts of SLE as reported by participants. It consists of 34 items in 8 different domains: physical health, emotional health, body image, pain, planning, fatigue, intimate relationship, and burden to others measured on a 5-point scale ranging from 0 (not at all) to 4 (very much). The individual domain scores are transformed to a 0 to 100 scale wherein higher scores indicate better quality of life. Pain domain score of LupusQoL had score range from 0 to 100, where higher scores = better quality of life. | FAS included all participants randomly assigned to study intervention and have received at least 1 dose of study intervention. Here, "Number of Participants Analyzed" signifies participants evaluable for this outcome measure with observed data at the specified visit. | Posted | Least Squares Mean | 95% Confidence Interval | Units on a scale | Baseline, Week 52 |
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| Secondary | Change From Baseline in Planning Domain Scores of LupusQoL at Week 52 | The LupusQoL questionnaire is a validated questionnaire used to evaluate SLE -specific concepts of SLE as reported by participants. It consists of 34 items in 8 different domains: physical health, emotional health, body image, pain, planning, fatigue, intimate relationship, and burden to others measured on a 5-point scale ranging from 0 (not at all) to 4 (very much). The individual domain scores are transformed to a 0 to 100 scale wherein higher scores indicate better quality of life. Planning domain score of LupusQoL had score range from 0 to 100, where higher scores = better quality of life. | FAS included all participants randomly assigned to study intervention and have received at least 1 dose of study intervention. Here, "Number of Participants Analyzed" signifies participants evaluable for this outcome measure with observed data at the specified visit. | Posted | Least Squares Mean | 95% Confidence Interval | Units on a scale | Baseline, Week 52 |
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| Secondary | Change From Baseline in Fatigue Domain Scores of LupusQoL at Week 52 | The LupusQoL questionnaire is a validated questionnaire used to evaluate SLE -specific concepts of SLE as reported by participants. It consists of 34 items in 8 different domains: physical health, emotional health, body image, pain, planning, fatigue, intimate relationship, and burden to others measured on a 5-point scale ranging from 0 (not at all) to 4 (very much). The individual domain scores are transformed to a 0 to 100 scale wherein higher scores indicate better quality of life. Fatigue domain score of LupusQoL had score range from 0 to 100, where higher scores = better quality of life. | FAS included all participants randomly assigned to study intervention and have received at least 1 dose of study intervention. Here, "Number of Participants Analyzed" signifies participants evaluable for this outcome measure with observed data at the specified visit. | Posted | Least Squares Mean | 95% Confidence Interval | Units on a scale | Baseline, Week 52 |
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| Secondary | Change From Baseline in Intimate Relationship Domain Scores of LupusQoL at Week 52 | The LupusQoL questionnaire is a validated questionnaire used to evaluate SLE -specific concepts of SLE as reported by participants. It consists of 34 items in 8 different domains: physical health, emotional health, body image, pain, planning, fatigue, intimate relationship, and burden to others measured on a 5-point scale ranging from 0 (not at all) to 4 (very much). The individual domain scores are transformed to a 0 to 100 scale wherein higher scores indicate better quality of life. Intimate relationship domain score of LupusQoL had score range from 0 to 100, where higher scores = better quality of life. | FAS included all participants randomly assigned to study intervention and have received at least 1 dose of study intervention. Here, "Number of Participants Analyzed" signifies participants evaluable for this outcome measure with observed data at the specified visit. | Posted | Least Squares Mean | 95% Confidence Interval | Units on a scale | Baseline, Week 52 |
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| Secondary | Change From Baseline in Burden to Others Domain Scores of LupusQoL at Week 52 | The LupusQoL questionnaire is a validated questionnaire used to evaluate SLE -specific concepts of SLE as reported by participants. It consists of 34 items in 8 different domains: physical health, emotional health, body image, pain, planning, fatigue, intimate relationship, and burden to others measured on a 5-point scale ranging from 0 (not at all) to 4 (very much). The individual domain scores are transformed to a 0 to 100 scale wherein higher scores indicate better quality of life. Burden to others domain score of LupusQoL had score range from 0 to 100, where higher scores = better quality of life. | FAS included all participants randomly assigned to study intervention and have received at least 1 dose of study intervention. Here, "Number of Participants Analyzed" signifies participants evaluable for this outcome measure with observed data at the specified visit. | Posted | Least Squares Mean | 95% Confidence Interval | Units on a scale | Baseline, Week 52 |
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| Secondary | Incidence Rate of Severe Flare Event | Incidence rate was defined as the number of new events per 100 person-years. | FAS included all participants randomly assigned to study intervention and have received at least 1 dose of study intervention. | Posted | Number | 95% Confidence Interval | Events per 100 person-years | Week 52 |
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| Secondary | Number of Participants With Treatment-Emergent Adverse Events (AE) | An AE was any untoward medical occurrence in a participant who received study intervention without regard to possibility of causal relationship. TEAEs are events from first dose of study intervention to 4 weeks after last dose of study intervention that were absent before treatment or that worsened relative to pre-treatment state. 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. AEs included both SAEs and all non-SAEs. | Safety analysis set included all participants who were randomly assigned to study intervention and who took at least 1 dose of study intervention. | Posted | Count of Participants | Participants | Day 1 of dosing up to 4 weeks after last dose of study drug (maximum treatment was up to 52 weeks, follow-up up to 56 weeks) |
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| Secondary | Number of Participants With Serious Adverse Events (SAEs) | An AE was any untoward medical occurrence in a participant who received study intervention without regard to possibility of causal relationship. 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. | Safety analysis set included all participants who were randomly assigned to study intervention and who took at least 1 dose of study intervention. | Posted | Count of Participants | Participants | Day 1 of dosing up to 4 weeks after last dose of study drug (maximum treatment was up to 52 weeks, follow-up up to 56 weeks) |
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| Secondary | Number of Participants With Adverse Events Leading to Discontinuation From Study | An AE was any untoward medical occurrence in a participant who received study intervention without regard to possibility of causal relationship. In this outcome measure, participants with adverse events leading to discontinuation from study were reported. | Safety analysis set included all participants who were randomly assigned to study intervention and who took at least 1 dose of study intervention. | Posted | Count of Participants | Participants | Day 1 of dosing up to 4 weeks after last dose of study drug (maximum treatment was up to 52 weeks, follow-up up to 56 weeks) |
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| Secondary | Number of Participants With Clinically Significant Vital Signs Abnormalities | Vital signs included blood pressure, pulse rate, respiratory rate, and temperature. Clinical significance in vital signs abnormalities was judged by investigator. | Safety analysis set included all participants who were randomly assigned to study intervention and who took at least 1 dose of study intervention. | Posted | Count of Participants | Participants | Day 1 of dosing up to 4 weeks after last dose of study drug (maximum treatment was up to 52 weeks, follow-up up to 56 weeks) |
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| Secondary | Number of Participants With Clinically Significant Electrocardiogram (ECG) Abnormalities | Clinical significance in ECG abnormalities was judged by investigator. | Safety analysis set included all participants who were randomly assigned to study intervention and who took at least 1 dose of study intervention. | Posted | Count of Participants | Participants | Day 1 of dosing up to 4 weeks after last dose of study drug (maximum treatment was up to 52 weeks, follow-up up to 56 weeks) |
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| Secondary | Number of Participants With Laboratory Test Abnormalities | Hematology (Hemoglobin[hgb], hematocrit, erythrocytes[ery]:<0.8*lower limit of normal[LLN];reticulocytes, reticulocytes/ery:<0.5*LLN,>1.5*upper LN[ULN];ery mean corpuscular volume[EMC], EMC hgb:<0.9*LLN,>1.5*ULN;EMC hgb concentration:<0.9* LLN;platelet:<0.5*LLN;leukocytes[leu]:<0.6*LLN,>1.5*ULN;lymphocytes, lymphocytes/leu, neutrophils, neutrophils/leu:<0.8* LLN,>1.2*ULN;basophils, basophils/leu, eosinophils, eosinophils/leu, monocytes, monocytes/leu:>1.2*ULN;activated partial thromboplastin time[PTT], PTT, prothrombin time:>1.1*ULN);Clinical chemistry (Total/direct/indirect bilirubin, glucose-fasting:>1.5*ULN; aspartate aminotransferase[AT], alanine AT:>3.0*ULN; protein, albumin, HDL cholesterol:<0.8*LLN;urea nitrogen, creatinine, triglyceride, cholesterol:>1.3*ULN;urate, LDL cholesterol:>1.2*ULN;potassium:<0.9*LLN,>1.1*ULN;calcium, bicarbonate:<0.9*LLN;creatine kinase:>2.0*ULN);Urinalysis (pH<4.5;glucose, protein, hgb, ketones, nitrite, leu esterase, granular/hyaline/WBCs casts:>1). | Safety analysis set included all participants who were randomly assigned to study intervention and who took at least 1 dose of study intervention. | Posted | Count of Participants | Participants | Day 1 of dosing up to 4 weeks after last dose of study drug (maximum treatment was up to 52 weeks, follow-up up to 56 weeks) |
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Day 1 of dosing up to 4 weeks after last dose of study drug (maximum up to 56 weeks)
Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during 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 | Participants were randomized to receive placebo matched to PF-06700841 QD for 52 weeks. Participants were followed up for 4 weeks after last dose. | 0 | 100 | 8 | 100 | 47 | 100 |
| EG001 | PF-06700841 15 mg | Participants were randomized to receive PF-06700841 15 mg tablets orally QD for 52 weeks. Participants were followed up for 4 weeks after last dose. | 0 | 50 | 4 | 50 | 19 | 50 |
| EG002 | PF-06700841 30 mg | Participants were randomized to receive PF-06700841 30 mg tablets orally QD for 52 weeks. Participants were followed up for 4 weeks after last dose. | 1 | 101 | 8 | 101 | 53 | 101 |
| EG003 | PF-06700841 45 mg | Participants were randomized to receive PF-06700841 45 mg tablets orally QD for 52 weeks. Participants were followed up for 4 weeks after last dose. | 1 | 99 | 9 | 99 | 47 | 99 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Haemorrhoids | Gastrointestinal disorders | MedDRA v26.0 | Non-systematic Assessment |
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| Intestinal strangulation | Gastrointestinal disorders | MedDRA v26.0 | Non-systematic Assessment |
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| Non-cardiac chest pain | General disorders | MedDRA v26.0 | Non-systematic Assessment |
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| Cholecystitis acute | Hepatobiliary disorders | MedDRA v26.0 | Non-systematic Assessment |
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| Hypersensitivity | Immune system disorders | MedDRA v26.0 | Non-systematic Assessment |
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| Bacteraemia | Infections and infestations | MedDRA v26.0 | Non-systematic Assessment |
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| COVID-19 | Infections and infestations | MedDRA v26.0 | Non-systematic Assessment |
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| COVID-19 pneumonia | Infections and infestations | MedDRA v26.0 | Non-systematic Assessment |
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| Gastroenteritis | Infections and infestations | MedDRA v26.0 | Non-systematic Assessment |
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| Periorbital cellulitis | Infections and infestations | MedDRA v26.0 | Non-systematic Assessment |
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| Pneumonia | Infections and infestations | MedDRA v26.0 | Non-systematic Assessment |
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| Upper respiratory tract infection | Infections and infestations | MedDRA v26.0 | Non-systematic Assessment |
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| Transaminases increased | Investigations | MedDRA v26.0 | Non-systematic Assessment |
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| Osteonecrosis | Musculoskeletal and connective tissue disorders | MedDRA v26.0 | Non-systematic Assessment |
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| Systemic lupus erythematosus | Musculoskeletal and connective tissue disorders | MedDRA v26.0 | Non-systematic Assessment |
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| Cutaneous T-cell lymphoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA v26.0 | Non-systematic Assessment |
| |
| Invasive breast carcinoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA v26.0 | Non-systematic Assessment |
| |
| Lupus encephalitis | Nervous system disorders | MedDRA v26.0 | Non-systematic Assessment |
| |
| Thalamic stroke | Nervous system disorders | MedDRA v26.0 | Non-systematic Assessment |
| |
| Lupus nephritis | Renal and urinary disorders | MedDRA v26.0 | Non-systematic Assessment |
| |
| Renal colic | Renal and urinary disorders | MedDRA v26.0 | Non-systematic Assessment |
| |
| Ureterolithiasis | Renal and urinary disorders | MedDRA v26.0 | Non-systematic Assessment |
| |
| Lupus pleurisy | Respiratory, thoracic and mediastinal disorders | MedDRA v26.0 | Non-systematic Assessment |
| |
| Circulatory collapse | Vascular disorders | MedDRA v26.0 | Non-systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Diarrhoea | Gastrointestinal disorders | MedDRA v26.0 | Non-systematic Assessment |
| |
| Nausea | Gastrointestinal disorders | MedDRA v26.0 | Non-systematic Assessment |
| |
| Vomiting | Gastrointestinal disorders | MedDRA v26.0 | Non-systematic Assessment |
| |
| Fatigue | General disorders | MedDRA v26.0 | Non-systematic Assessment |
| |
| COVID-19 | Infections and infestations | MedDRA v26.0 | Non-systematic Assessment |
| |
| Cystitis | Infections and infestations | MedDRA v26.0 | Non-systematic Assessment |
| |
| Nasopharyngitis | Infections and infestations | MedDRA v26.0 | Non-systematic Assessment |
| |
| Oral candidiasis | Infections and infestations | MedDRA v26.0 | Non-systematic Assessment |
| |
| Upper respiratory tract infection | Infections and infestations | MedDRA v26.0 | Non-systematic Assessment |
| |
| Urinary tract infection | Infections and infestations | MedDRA v26.0 | Non-systematic Assessment |
| |
| Blood creatine phosphokinase increased | Investigations | MedDRA v26.0 | Non-systematic Assessment |
| |
| Headache | Nervous system disorders | MedDRA v26.0 | Non-systematic Assessment |
|
For the PF-06700841 30 mg, there was a total of 1 death which was reported in both on-treatment and follow-up phases in participant flow section.
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 |
| Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Oct 25, 2023 | Jun 28, 2024 | SAP_001.pdf |
Not provided
| ID | Term |
|---|---|
| D008180 | Lupus Erythematosus, Systemic |
| ID | Term |
|---|---|
| D003240 | Connective Tissue Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D001327 | Autoimmune Diseases |
| D007154 | Immune System Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| C000630838 | PF-06700841 |
Not provided
Not provided
Not provided
| Death |
|
| Lost to Follow-up |
|
| Physician's decision |
|
| Study terminated by sponsor |
|
| Other |
|
| Pregnancy |
|
| Protocol Violation |
|
| Withdrawal by Subject |
|
| Male |
|
| Not Hispanic or Latino |
|
| Unknown or Not Reported |
|
| Asian |
|
| Native Hawaiian or Other Pacific Islander |
|
| Black or African American |
|
| White |
|
| More than one race |
|
| Unknown or Not Reported |
|
| 0.2189 |
One sided p-value. |
| Risk Difference (RD) |
| 5.2 |
| 2-Sided |
| 95 |
| -7.9 |
| 18.3 |
| Superiority |
| Cochran-Mantel-Haenszel | 0.4010 | One sided p-value. | Risk Difference (RD) | 1.7 | 2-Sided | 95 | -11.8 | 15.3 | Superiority |
Participants were randomized to receive PF-06700841 15 mg tablets orally QD for 52 weeks. Participants were followed up for 4 weeks after last dose.
| OG002 | PF-06700841 30 mg | Participants were randomized to receive PF-06700841 30 mg tablets orally QD for 52 weeks. Participants were followed up for 4 weeks after last dose. |
| OG003 | PF-06700841 45 mg | Participants were randomized to receive PF-06700841 45 mg tablets orally QD for 52 weeks. Participants were followed up for 4 weeks after last dose. |
|
|
|
| OG002 |
| PF-06700841 30 mg |
Participants were randomized to receive PF-06700841 30 mg tablets orally QD for 52 weeks. Participants were followed up for 4 weeks after last dose. |
| OG003 | PF-06700841 45 mg | Participants were randomized to receive PF-06700841 45 mg tablets orally QD for 52 weeks. Participants were followed up for 4 weeks after last dose. |
|
|
| PF-06700841 30 mg |
Participants were randomized to receive PF-06700841 30 mg tablets orally QD for 52 weeks. Participants were followed up for 4 weeks after last dose. |
| OG003 | PF-06700841 45 mg | Participants were randomized to receive PF-06700841 45 mg tablets orally QD for 52 weeks. Participants were followed up for 4 weeks after last dose. |
|
|
Participants were randomized to receive PF-06700841 30 mg tablets orally QD for 52 weeks. Participants were followed up for 4 weeks after last dose.
| OG003 | PF-06700841 45 mg | Participants were randomized to receive PF-06700841 45 mg tablets orally QD for 52 weeks. Participants were followed up for 4 weeks after last dose. |
|
|
| OG002 | PF-06700841 30 mg | Participants were randomized to receive PF-06700841 30 mg tablets orally QD for 52 weeks. Participants were followed up for 4 weeks after last dose. |
| OG003 | PF-06700841 45 mg | Participants were randomized to receive PF-06700841 45 mg tablets orally QD for 52 weeks. Participants were followed up for 4 weeks after last dose. |
|
|
Participants were randomized to receive PF-06700841 30 mg tablets orally QD for 52 weeks. Participants were followed up for 4 weeks after last dose. |
| OG003 | PF-06700841 45 mg | Participants were randomized to receive PF-06700841 45 mg tablets orally QD for 52 weeks. Participants were followed up for 4 weeks after last dose. |
|
|
| OG002 | PF-06700841 30 mg | Participants were randomized to receive PF-06700841 30 mg tablets orally QD for 52 weeks. Participants were followed up for 4 weeks after last dose. |
| OG003 | PF-06700841 45 mg | Participants were randomized to receive PF-06700841 45 mg tablets orally QD for 52 weeks. Participants were followed up for 4 weeks after last dose. |
|
|
| OG002 | PF-06700841 30 mg | Participants were randomized to receive PF-06700841 30 mg tablets orally QD for 52 weeks. Participants were followed up for 4 weeks after last dose. |
| OG003 | PF-06700841 45 mg | Participants were randomized to receive PF-06700841 45 mg tablets orally QD for 52 weeks. Participants were followed up for 4 weeks after last dose. |
|
|
| OG002 | PF-06700841 30 mg | Participants were randomized to receive PF-06700841 30 mg tablets orally QD for 52 weeks. Participants were followed up for 4 weeks after last dose. |
| OG003 | PF-06700841 45 mg | Participants were randomized to receive PF-06700841 45 mg tablets orally QD for 52 weeks. Participants were followed up for 4 weeks after last dose. |
|
|
| OG002 |
| PF-06700841 30 mg |
Participants were randomized to receive PF-06700841 30 mg tablets orally QD for 52 weeks. Participants were followed up for 4 weeks after last dose. |
| OG003 | PF-06700841 45 mg | Participants were randomized to receive PF-06700841 45 mg tablets orally QD for 52 weeks. Participants were followed up for 4 weeks after last dose. |
|
|
| OG002 |
| PF-06700841 30 mg |
Participants were randomized to receive PF-06700841 30 mg tablets orally QD for 52 weeks. Participants were followed up for 4 weeks after last dose. |
| OG003 | PF-06700841 45 mg | Participants were randomized to receive PF-06700841 45 mg tablets orally QD for 52 weeks. Participants were followed up for 4 weeks after last dose. |
|
|
| OG002 |
| PF-06700841 30 mg |
Participants were randomized to receive PF-06700841 30 mg tablets orally QD for 52 weeks. Participants were followed up for 4 weeks after last dose. |
| OG003 | PF-06700841 45 mg | Participants were randomized to receive PF-06700841 45 mg tablets orally QD for 52 weeks. Participants were followed up for 4 weeks after last dose. |
|
|
| OG002 | PF-06700841 30 mg | Participants were randomized to receive PF-06700841 30 mg tablets orally QD for 52 weeks. Participants were followed up for 4 weeks after last dose. |
| OG003 | PF-06700841 45 mg | Participants were randomized to receive PF-06700841 45 mg tablets orally QD for 52 weeks. Participants were followed up for 4 weeks after last dose. |
|
|
| OG002 | PF-06700841 30 mg | Participants were randomized to receive PF-06700841 30 mg tablets orally QD for 52 weeks. Participants were followed up for 4 weeks after last dose. |
| OG003 | PF-06700841 45 mg | Participants were randomized to receive PF-06700841 45 mg tablets orally QD for 52 weeks. Participants were followed up for 4 weeks after last dose. |
|
|
|
|
| OG002 | PF-06700841 30 mg | Participants were randomized to receive PF-06700841 30 mg tablets orally QD for 52 weeks. Participants were followed up for 4 weeks after last dose. |
| OG003 | PF-06700841 45 mg | Participants were randomized to receive PF-06700841 45 mg tablets orally QD for 52 weeks. Participants were followed up for 4 weeks after last dose. |
|
|
| OG003 | PF-06700841 45 mg | Participants were randomized to receive PF-06700841 45 mg tablets orally QD for 52 weeks. Participants were followed up for 4 weeks after last dose. |
|
|
| OG003 | PF-06700841 45 mg | Participants were randomized to receive PF-06700841 45 mg tablets orally QD for 52 weeks. Participants were followed up for 4 weeks after last dose. |
|
|
| OG003 |
| PF-06700841 45 mg |
Participants were randomized to receive PF-06700841 45 mg tablets orally QD for 52 weeks. Participants were followed up for 4 weeks after last dose. |
|
|
Participants were randomized to receive PF-06700841 45 mg tablets orally QD for 52 weeks. Participants were followed up for 4 weeks after last dose. |
|
|
| OG001 |
| PF-06700841 15 mg |
Participants were randomized to receive PF-06700841 15 mg tablets orally QD for 52 weeks. Participants were followed up for 4 weeks after last dose. |
| OG002 | PF-06700841 30 mg | Participants were randomized to receive PF-06700841 30 mg tablets orally QD for 52 weeks. Participants were followed up for 4 weeks after last dose. |
| OG003 | PF-06700841 45 mg | Participants were randomized to receive PF-06700841 45 mg tablets orally QD for 52 weeks. Participants were followed up for 4 weeks after last dose. |
|
|