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| ID | Type | Description | Link |
|---|---|---|---|
| 2008-000327-25 | EudraCT Number |
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CE-224,535 is known to block a chemical that acts as a gateway to some of your immune cells. Blocking this gateway prevents the cells from pushing out 2 chemicals called IL-1 and IL-18 that are known to cause some of the inflammation seen in rheumatoid arthritis. It is hoped that taking this drug will reduce the symptoms of rheumatoid arthritis
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Active | Experimental |
| |
| Placebo | Placebo Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| CE-224,535 | Drug | 500 mg po BID |
| |
| Placebo |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Participants With American College of Rheumatology 20% (ACR20) Response at Week 12 | ACR20 response: compared to baseline, greater than or equal to (>=) 20 percent (%) improvement in tender joint count; >= 20% improvement in swollen joint count; and >= 20% improvement in at least 3 of 5 remaining ACR core measures: participant assessment of pain; participant global assessment of disease activity; physician global assessment of disease activity; self-assessed disability (disability index of the Health Assessment Questionnaire [HAQ]); and C-Reactive Protein (CRP). | Week 12 |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Participants With American College of Rheumatology 20% (ACR20) Response at Week 2, 4 and 8 | ACR20 response: compared to baseline, >=20% improvement in tender joint count; >= 20% improvement in swollen joint count; and >= 20% improvement in at least 3 of 5 remaining ACR core measures: participant assessment of pain; participant global assessment of disease activity; physician global assessment of disease activity; self-assessed disability (disability index of the Health Assessment Questionnaire [HAQ]); and C-Reactive Protein (CRP). |
| Measure | Description | Time Frame |
|---|---|---|
| CE-224,535 Plasma Concentrations | Nominal times were used for summarizing the pharmacokinetic results (0 hours at randomization [Day 1] and Week 4 [pre-dose]; 1 hour at Week 2 [post-dose]; 2 hours at randomization [post-dose on Day 1]; and 3 hours at Week 2 [post-dose] and Week 4 [post-dose]). | 0 hour (pre-dose), 2 hours post-dose at Day 1; 1, 3 hours post-dose at Week 2; 0 hour (pre-dose), 3 hours post-dose at Week 4 |
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 |
|---|---|---|---|---|---|---|
| Arizona Arthritis & Rheumatology Associates, P.C. | Mesa | Arizona | 85202 | United States | ||
| Omega Research Consultants LLC |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 22382341 | Derived | Stock TC, Bloom BJ, Wei N, Ishaq S, Park W, Wang X, Gupta P, Mebus CA. Efficacy and safety of CE-224,535, an antagonist of P2X7 receptor, in treatment of patients with rheumatoid arthritis inadequately controlled by methotrexate. J Rheumatol. 2012 Apr;39(4):720-7. doi: 10.3899/jrheum.110874. Epub 2012 Mar 1. |
| 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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| ID | Title | Description |
|---|---|---|
| FG000 | CE-224,535 | CE-224,535 500 milligram (mg) tablet orally twice daily for 12 weeks. |
| FG001 | Placebo | Placebo tablet matched to CE-224,535 500 mg tablet orally twice daily for 12 weeks. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
Not provided
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| Drug |
no active ingredient |
|
| Week 2, 4, 8 |
| Percentage of Participants With American College of Rheumatology 50% (ACR50) Response | ACR50 response: compared to baseline, >=50% improvement in tender joint count; >= 50% improvement in swollen joint count; and >= 50% improvement in at least 3 of 5 remaining ACR core measures: participant assessment of pain; participant global assessment of disease activity; physician global assessment of disease activity; self-assessed disability (disability index of the Health Assessment Questionnaire [HAQ]); and C-Reactive Protein (CRP). | Week 2, 4, 8, 12 |
| Percentage of Participants With American College of Rheumatology 70% (ACR70) Response | ACR70 response: compared to baseline, >=70% improvement in tender joint count; >= 70% improvement in swollen joint count; and >= 70% improvement in at least 3 of 5 remaining ACR core measures: participant assessment of pain; participant global assessment of disease activity; physician global assessment of disease activity; self-assessed disability (disability index of the Health Assessment Questionnaire [HAQ]); and C-Reactive Protein (CRP). | Week 2, 4, 8, 12 |
| Number of Tender/Painful and Swollen Joints | Number of tender/painful joints was determined by examining 28 joints and identified the joints that were painful under pressure or to passive motion. The number of tender joints was recorded on the joint assessment form at each visit, no tenderness = 0, tenderness = 1. Number of swollen joints was determined by examination of 28 joints and identifying when swelling was present. The number of swollen joints was recorded on the joint assessment form at each visit, no swelling = 0, swelling =1. | Baseline, Week 2, 4, 8, 12 |
| Physician Global Assessment (PGA) of Arthritis | Physician global assessment of arthritis was measured on a 0 to 100 millimeter (mm) Visual Analog Scale (VAS), with 0 mm= very good and 100 mm= very poor. This was an evaluation based on the participant's disease signs, functional capacity and physical examination. | Baseline, Week 2, 4, 8, 12 |
| Patient's Global Assessment of Arthritis | Participants answered: "Considering all the ways your arthritis affects you, how are you feeling today?" Participants responded by using a 0 to 100 mm VAS, with 0 mm= very well and 100 mm= very poorly. | Baseline, Week 2, 4, 8, 12 |
| Patient's Global Assessment of Arthritic Pain | Participants measured their pain at the time of assessment on a 0 to 100 mm VAS, with 0 mm= no pain and 100 mm= most severe pain. | Baseline, Week 2, 4, 8, 12 |
| Health Assessment Questionnaire-Disability Index (HAQ-DI) Score | Health Assessment Questionnaire-Disability Index (HAQ-DI): participant-reported assessment of ability to perform tasks in 8 categories of daily living activities: dress/groom; arise; eat; walk; reach; grip; hygiene; and common activities over past week. Each item scored on 4-point scale from 0 to 3: 0= no difficulty; 1= some difficulty; 2= much difficulty; 3= unable to do. Overall score was computed as the sum of domain scores and divided by the number of domains answered. Total possible score range 0-3 where 0= least difficulty and 3= extreme difficulty. | Baseline, Week 2, 4, 8, 12 |
| Disease Activity Score Based on 28-Joints Count and C-Reactive Protein (3 Variables) (DAS28-3 [CRP]) | DAS28-3 (CRP) was calculated from the swollen joint count and tender joint count using the 28 joints count and CRP (milligram per liter [mg/L]). Total score range: 0 to 9.4, higher score indicated more disease activity. DAS28-3 (CRP) less than or equal to (<=) 3.2 implied low disease activity and >3.2 to 5.1 implied moderate to high disease activity, and DAS28-3 (CRP) <2.6 = remission. | Baseline, Week 2, 4, 8, 12 |
| C-Reactive Protein (CRP) | The test for CRP is a laboratory measurement for evaluation of an acute phase reactant of inflammation through the use of an ultrasensitive assay. A decrease in the level of CRP indicates reduction in inflammation and therefore improvement. | Baseline, Week 2, 4, 8, 12 |
| Incidence of Withdrawal Due to Lack of Efficacy | Number of participants who withrew due to lack of efficacy were reported. | Week 2, 4, 8, 12, 14 |
| Time to Withdrawal Due to Lack of Efficacy | Baseline up to Week 14 |
| DeBary |
| Florida |
| 32713 |
| United States |
| Florida Arthritis Center | Lake Mary | Florida | 32746 | United States |
| Tampa Medical Group, PA | Tampa | Florida | 33614 | United States |
| American Health Network | Avon | Indiana | 46123 | United States |
| Best Clinical Trials, LLC (Administrative Only) | New Orleans | Louisiana | 70115 | United States |
| George Stanley Walker, MD | New Orleans | Louisiana | 70115 | United States |
| Majid Abdul Jawad, MD | New Orleans | Louisiana | 70115 | United States |
| The Arthritis and Osteoporosis Center of Maryland | Frederick | Maryland | 21702 | United States |
| University Physicians | Columbia | Missouri | 65203 | United States |
| University of Missouri-Columbia | Columbia | Missouri | 65212 | United States |
| Arthritis Center of Reno | Reno | Nevada | 89502 | United States |
| New Horizons Clinical Research | Cincinnati | Ohio | 45242 | United States |
| Arthritis Northwest | Spokane | Washington | 99204-2336 | United States |
| Clínica Santa María, Sección Reumatología | Providencia | Santiago, RM | 7530206 | Chile |
| Revmatologicka ambulance | Česká Lípa | 470 01 | Czechia |
| Revmatologicky ustav | Prague | 128 50 | Czechia |
| Revmatologicka ambulance | Prague | 140 00 | Czechia |
| Investigadores Clinicos Asociados | México | D.F. | 03300 | Mexico |
| Krakowskie Centrum Medyczne NZOZ | Krakow | 31-501 | Poland |
| Zaklad Reumatologii i Immunologii Klinicznej | Poznan | 60-356 | Poland |
| Oddzial Reumatologiczno-Rehabilitacyjny IIR Ortopedyczno-Rehabilitacyjny | Poznan | 61-545 | Poland |
| Inha University Hospital, Medicine/Rheumatology | Incheon | 400-711 | South Korea |
| Pusan National University Hospital, Rheumatology, Internal Medicine | Pusan | 602-739 | South Korea |
| Hospital Nuestra Señora de La Esperanza | Santiago de Compostela | A Coruña | 15705 | Spain |
| Complexo Hospitalario Universitario A Coruña | A Coruña | 15006 | Spain |
| Hospital General Universitario Gregorio Marañon | Madrid | 28007 | Spain |
| COMPLETED |
|
| NOT COMPLETED |
|
|
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | CE-224,535 | CE-224,535 500 milligram (mg) tablet orally twice daily for 12 weeks. |
| BG001 | Placebo | Placebo tablet matched to CE-224,535 500 milligram (mg) tablet orally twice daily for 12 weeks. |
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | years |
| |||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
|
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Percentage of Participants With American College of Rheumatology 20% (ACR20) Response at Week 12 | ACR20 response: compared to baseline, greater than or equal to (>=) 20 percent (%) improvement in tender joint count; >= 20% improvement in swollen joint count; and >= 20% improvement in at least 3 of 5 remaining ACR core measures: participant assessment of pain; participant global assessment of disease activity; physician global assessment of disease activity; self-assessed disability (disability index of the Health Assessment Questionnaire [HAQ]); and C-Reactive Protein (CRP). | Full Analysis Set (FAS) included all randomized participants who received at least 1 dose of the randomized study medication. Last observation carried forward (LOCF) was used to impute missing ACR components before computing ACR20 response. | Posted | Number | Percentage of participants | Week 12 |
|
|
|
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Percentage of Participants With American College of Rheumatology 20% (ACR20) Response at Week 2, 4 and 8 | ACR20 response: compared to baseline, >=20% improvement in tender joint count; >= 20% improvement in swollen joint count; and >= 20% improvement in at least 3 of 5 remaining ACR core measures: participant assessment of pain; participant global assessment of disease activity; physician global assessment of disease activity; self-assessed disability (disability index of the Health Assessment Questionnaire [HAQ]); and C-Reactive Protein (CRP). | FAS included all randomized participants who received at least 1 dose of the randomized study medication. LOCF was used to impute missing ACR components before computing ACR20 response. | Posted | Number | Percentage of participants | Week 2, 4, 8 |
|
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Percentage of Participants With American College of Rheumatology 50% (ACR50) Response | ACR50 response: compared to baseline, >=50% improvement in tender joint count; >= 50% improvement in swollen joint count; and >= 50% improvement in at least 3 of 5 remaining ACR core measures: participant assessment of pain; participant global assessment of disease activity; physician global assessment of disease activity; self-assessed disability (disability index of the Health Assessment Questionnaire [HAQ]); and C-Reactive Protein (CRP). | FAS included all randomized participants who received at least 1 dose of the randomized study medication. LOCF was used to impute missing ACR components before computing ACR50 response. | Posted | Number | Percentage of participants | Week 2, 4, 8, 12 |
|
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Percentage of Participants With American College of Rheumatology 70% (ACR70) Response | ACR70 response: compared to baseline, >=70% improvement in tender joint count; >= 70% improvement in swollen joint count; and >= 70% improvement in at least 3 of 5 remaining ACR core measures: participant assessment of pain; participant global assessment of disease activity; physician global assessment of disease activity; self-assessed disability (disability index of the Health Assessment Questionnaire [HAQ]); and C-Reactive Protein (CRP). | FAS included all randomized participants who received at least 1 dose of the randomized study medication. LOCF was used to impute missing ACR components before computing ACR70 response. | Posted | Number | Percentage of participants | Week 2, 4, 8, 12 |
|
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Number of Tender/Painful and Swollen Joints | Number of tender/painful joints was determined by examining 28 joints and identified the joints that were painful under pressure or to passive motion. The number of tender joints was recorded on the joint assessment form at each visit, no tenderness = 0, tenderness = 1. Number of swollen joints was determined by examination of 28 joints and identifying when swelling was present. The number of swollen joints was recorded on the joint assessment form at each visit, no swelling = 0, swelling =1. | FAS included all randomized participants who received at least 1 dose of the randomized study medication. Here, 'number analyzed' signifies those participants who were evaluable for this measure at given time points for each group, respectively. | Posted | Mean | Standard Deviation | Joints | Baseline, Week 2, 4, 8, 12 |
|
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Physician Global Assessment (PGA) of Arthritis | Physician global assessment of arthritis was measured on a 0 to 100 millimeter (mm) Visual Analog Scale (VAS), with 0 mm= very good and 100 mm= very poor. This was an evaluation based on the participant's disease signs, functional capacity and physical examination. | FAS included all randomized participants who received at least 1 dose of the randomized study medication. Here, 'number analyzed' signifies those participants who were evaluable for this measure at given time points for each group, respectively. | Posted | Mean | Standard Deviation | mm | Baseline, Week 2, 4, 8, 12 |
|
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Patient's Global Assessment of Arthritis | Participants answered: "Considering all the ways your arthritis affects you, how are you feeling today?" Participants responded by using a 0 to 100 mm VAS, with 0 mm= very well and 100 mm= very poorly. | FAS included all randomized participants who received at least 1 dose of the randomized study medication. Here, 'number analyzed' signifies those participants who were evaluable for this measure at given time points for each group, respectively. | Posted | Mean | Standard Deviation | mm | Baseline, Week 2, 4, 8, 12 |
|
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Patient's Global Assessment of Arthritic Pain | Participants measured their pain at the time of assessment on a 0 to 100 mm VAS, with 0 mm= no pain and 100 mm= most severe pain. | FAS included all randomized participants who received at least 1 dose of the randomized study medication. Here, 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure and 'number analyzed' signifies those participants who were evaluable for this measure at given time points for each group, respectively. | Posted | Mean | Standard Deviation | mm | Baseline, Week 2, 4, 8, 12 |
|
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Health Assessment Questionnaire-Disability Index (HAQ-DI) Score | Health Assessment Questionnaire-Disability Index (HAQ-DI): participant-reported assessment of ability to perform tasks in 8 categories of daily living activities: dress/groom; arise; eat; walk; reach; grip; hygiene; and common activities over past week. Each item scored on 4-point scale from 0 to 3: 0= no difficulty; 1= some difficulty; 2= much difficulty; 3= unable to do. Overall score was computed as the sum of domain scores and divided by the number of domains answered. Total possible score range 0-3 where 0= least difficulty and 3= extreme difficulty. | FAS included all randomized participants who received at least 1 dose of the randomized study medication. Here, 'n' signifies those participants who were evaluable for this measure at given time points for each group, respectively. | Posted | Mean | Standard Deviation | units on a scale | Baseline, Week 2, 4, 8, 12 |
|
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Disease Activity Score Based on 28-Joints Count and C-Reactive Protein (3 Variables) (DAS28-3 [CRP]) | DAS28-3 (CRP) was calculated from the swollen joint count and tender joint count using the 28 joints count and CRP (milligram per liter [mg/L]). Total score range: 0 to 9.4, higher score indicated more disease activity. DAS28-3 (CRP) less than or equal to (<=) 3.2 implied low disease activity and >3.2 to 5.1 implied moderate to high disease activity, and DAS28-3 (CRP) <2.6 = remission. | FAS included all randomized participants who received at least 1 dose of the randomized study medication. Here, 'n' signifies those participants who were evaluable for this measure at given time points for each group, respectively. | Posted | Mean | Standard Deviation | units on a scale | Baseline, Week 2, 4, 8, 12 |
|
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | C-Reactive Protein (CRP) | The test for CRP is a laboratory measurement for evaluation of an acute phase reactant of inflammation through the use of an ultrasensitive assay. A decrease in the level of CRP indicates reduction in inflammation and therefore improvement. | FAS included all randomized participants who received at least 1 dose of the randomized study medication. Here, 'n' signifies those participants who were evaluable for this measure at given time points for each group, respectively. | Posted | Mean | Standard Deviation | milligram per liter (mg/L) | Baseline, Week 2, 4, 8, 12 |
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| Secondary | Incidence of Withdrawal Due to Lack of Efficacy | Number of participants who withrew due to lack of efficacy were reported. | FAS included all randomized participants who received at least 1 dose of the randomized study medication. | Posted | Number | participants | Week 2, 4, 8, 12, 14 |
|
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| Secondary | Time to Withdrawal Due to Lack of Efficacy | Results are not reported because median time could not be estimated as very few participants discontinued study due to lack of efficacy. | Posted | Baseline up to Week 14 |
|
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| Other Pre-specified | CE-224,535 Plasma Concentrations | Nominal times were used for summarizing the pharmacokinetic results (0 hours at randomization [Day 1] and Week 4 [pre-dose]; 1 hour at Week 2 [post-dose]; 2 hours at randomization [post-dose on Day 1]; and 3 hours at Week 2 [post-dose] and Week 4 [post-dose]). | FAS included all randomized participants who received at least 1 dose of the randomized study medication. | Posted | Median | Full Range | nanogram per milliliter (ng/mL) | 0 hour (pre-dose), 2 hours post-dose at Day 1; 1, 3 hours post-dose at Week 2; 0 hour (pre-dose), 3 hours post-dose at Week 4 |
|
|
Not provided
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 subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious 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 | CE-224,535 | CE-224,535 500 milligram (mg) tablet orally twice daily for 12 weeks. | 2 | 53 | 32 | 53 | ||
| EG001 | Placebo | Placebo tablet matched to CE-224,535 500 milligram (mg) tablet orally twice daily for 12 weeks. | 1 | 47 | 26 | 47 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Back injury | Injury, poisoning and procedural complications | MedDRA 11.1 | Non-systematic Assessment |
| |
| Capsular contracture associated with breast implant | Injury, poisoning and procedural complications | MedDRA 11.1 | Non-systematic Assessment |
| |
| Contusion | Injury, poisoning and procedural complications | MedDRA 11.1 | Non-systematic Assessment |
| |
| Pelvic fracture | Injury, poisoning and procedural complications | MedDRA 11.1 | Non-systematic Assessment |
| |
| Road traffic accident | Injury, poisoning and procedural complications | MedDRA 11.1 | Non-systematic Assessment |
| |
| Depression | Psychiatric disorders | MedDRA 11.1 | Non-systematic Assessment |
| |
| Breast prosthesis implantation | Surgical and medical procedures | MedDRA 11.1 | Non-systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Leukopenia | Blood and lymphatic system disorders | MedDRA 11.1 | Non-systematic Assessment |
| |
| Lymphopenia | Blood and lymphatic system disorders | MedDRA 11.1 | Non-systematic Assessment |
| |
| Neutropenia | Blood and lymphatic system disorders | MedDRA 11.1 | Non-systematic Assessment |
| |
| Thrombocytopenia | Blood and lymphatic system disorders | MedDRA 11.1 | Non-systematic Assessment |
| |
| Tachycardia | Cardiac disorders | MedDRA 11.1 | Non-systematic Assessment |
| |
| Ear canal erythema | Ear and labyrinth disorders | MedDRA 11.1 | Non-systematic Assessment |
| |
| Ear pain | Ear and labyrinth disorders | MedDRA 11.1 | Non-systematic Assessment |
| |
| Conjunctivitis | Eye disorders | MedDRA 11.1 | Non-systematic Assessment |
| |
| Diplopia | Eye disorders | MedDRA 11.1 | Non-systematic Assessment |
| |
| Dry eye | Eye disorders | MedDRA 11.1 | Non-systematic Assessment |
| |
| Abdominal pain | Gastrointestinal disorders | MedDRA 11.1 | Non-systematic Assessment |
| |
| Abdominal pain upper | Gastrointestinal disorders | MedDRA 11.1 | Non-systematic Assessment |
| |
| Abdominal tenderness | Gastrointestinal disorders | MedDRA 11.1 | Non-systematic Assessment |
| |
| Aphthous stomatitis | Gastrointestinal disorders | MedDRA 11.1 | Non-systematic Assessment |
| |
| Diarrhoea | Gastrointestinal disorders | MedDRA 11.1 | Non-systematic Assessment |
| |
| Dry mouth | Gastrointestinal disorders | MedDRA 11.1 | Non-systematic Assessment |
| |
| Dyspepsia | Gastrointestinal disorders | MedDRA 11.1 | Non-systematic Assessment |
| |
| Epigastric discomfort | Gastrointestinal disorders | MedDRA 11.1 | Non-systematic Assessment |
| |
| Eructation | Gastrointestinal disorders | MedDRA 11.1 | Non-systematic Assessment |
| |
| Frequent bowel movements | Gastrointestinal disorders | MedDRA 11.1 | Non-systematic Assessment |
| |
| Nausea | Gastrointestinal disorders | MedDRA 11.1 | Non-systematic Assessment |
| |
| Oral disorder | Gastrointestinal disorders | MedDRA 11.1 | Non-systematic Assessment |
| |
| Vomiting | Gastrointestinal disorders | MedDRA 11.1 | Non-systematic Assessment |
| |
| Fatigue | General disorders | MedDRA 11.1 | Non-systematic Assessment |
| |
| Feeling hot | General disorders | MedDRA 11.1 | Non-systematic Assessment |
| |
| Oedema peripheral | General disorders | MedDRA 11.1 | Non-systematic Assessment |
| |
| Pyrexia | General disorders | MedDRA 11.1 | Non-systematic Assessment |
| |
| Seasonal allergy | Immune system disorders | MedDRA 11.1 | Non-systematic Assessment |
| |
| Bronchitis | Infections and infestations | MedDRA 11.1 | Non-systematic Assessment |
| |
| Folliculitis | Infections and infestations | MedDRA 11.1 | Non-systematic Assessment |
| |
| Fungal skin infection | Infections and infestations | MedDRA 11.1 | Non-systematic Assessment |
| |
| Gastroenteritis | Infections and infestations | MedDRA 11.1 | Non-systematic Assessment |
| |
| Hordeolum | Infections and infestations | MedDRA 11.1 | Non-systematic Assessment |
| |
| Influenza | Infections and infestations | MedDRA 11.1 | Non-systematic Assessment |
| |
| Nasopharyngitis | Infections and infestations | MedDRA 11.1 | Non-systematic Assessment |
| |
| Oral herpes | Infections and infestations | MedDRA 11.1 | Non-systematic Assessment |
| |
| Pharyngitis | Infections and infestations | MedDRA 11.1 | Non-systematic Assessment |
| |
| Pneumonia | Infections and infestations | MedDRA 11.1 | Non-systematic Assessment |
| |
| Sinusitis | Infections and infestations | MedDRA 11.1 | Non-systematic Assessment |
| |
| Upper respiratory tract infection | Infections and infestations | MedDRA 11.1 | Non-systematic Assessment |
| |
| Urinary tract infection | Infections and infestations | MedDRA 11.1 | Non-systematic Assessment |
| |
| Viral infection | Infections and infestations | MedDRA 11.1 | Non-systematic Assessment |
| |
| Contusion | Injury, poisoning and procedural complications | MedDRA 11.1 | Non-systematic Assessment |
| |
| Hand fracture | Injury, poisoning and procedural complications | MedDRA 11.1 | Non-systematic Assessment |
| |
| Skin injury | Injury, poisoning and procedural complications | MedDRA 11.1 | Non-systematic Assessment |
| |
| Alanine aminotransferase increased | Investigations | MedDRA 11.1 | Non-systematic Assessment |
| |
| Aspartate aminotransferase increased | Investigations | MedDRA 11.1 | Non-systematic Assessment |
| |
| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA 11.1 | Non-systematic Assessment |
| |
| Arthritis | Musculoskeletal and connective tissue disorders | MedDRA 11.1 | Non-systematic Assessment |
| |
| Back pain | Musculoskeletal and connective tissue disorders | MedDRA 11.1 | Non-systematic Assessment |
| |
| Costochondritis | Musculoskeletal and connective tissue disorders | MedDRA 11.1 | Non-systematic Assessment |
| |
| Joint stiffness | Musculoskeletal and connective tissue disorders | MedDRA 11.1 | Non-systematic Assessment |
| |
| Lumbar spinal stenosis | Musculoskeletal and connective tissue disorders | MedDRA 11.1 | Non-systematic Assessment |
| |
| Muscle spasms | Musculoskeletal and connective tissue disorders | MedDRA 11.1 | Non-systematic Assessment |
| |
| Myalgia | Musculoskeletal and connective tissue disorders | MedDRA 11.1 | Non-systematic Assessment |
| |
| Neck pain | Musculoskeletal and connective tissue disorders | MedDRA 11.1 | Non-systematic Assessment |
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| Pain in extremity | Musculoskeletal and connective tissue disorders | MedDRA 11.1 | Non-systematic Assessment |
| |
| Rheumatoid arthritis | Musculoskeletal and connective tissue disorders | MedDRA 11.1 | Non-systematic Assessment |
| |
| Tendon pain | Musculoskeletal and connective tissue disorders | MedDRA 11.1 | Non-systematic Assessment |
| |
| Tendonitis | Musculoskeletal and connective tissue disorders | MedDRA 11.1 | Non-systematic Assessment |
| |
| Meningioma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 11.1 | Non-systematic Assessment |
| |
| Headache | Nervous system disorders | MedDRA 11.1 | Non-systematic Assessment |
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| Lethargy | Nervous system disorders | MedDRA 11.1 | Non-systematic Assessment |
| |
| Nerve compression | Nervous system disorders | MedDRA 11.1 | Non-systematic Assessment |
| |
| Insomnia | Psychiatric disorders | MedDRA 11.1 | Non-systematic Assessment |
| |
| Renal failure | Renal and urinary disorders | MedDRA 11.1 | Non-systematic Assessment |
| |
| Sinus congestion | Respiratory, thoracic and mediastinal disorders | MedDRA 11.1 | Non-systematic Assessment |
| |
| Dermatitis contact | Skin and subcutaneous tissue disorders | MedDRA 11.1 | Non-systematic Assessment |
| |
| Hyperhidrosis | Skin and subcutaneous tissue disorders | MedDRA 11.1 | Non-systematic Assessment |
| |
| Rash | Skin and subcutaneous tissue disorders | MedDRA 11.1 | Non-systematic Assessment |
| |
| Hypertension | Vascular disorders | MedDRA 11.1 | 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 |
Not provided
Not provided
| ID | Term |
|---|---|
| C562356 | CE 224,535 |
Not provided
Not provided
Not provided
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