An observational study in Arthritis, Rheumatoid and High Dose, sponsored by Pfizer. Completed at 1 site in Japan. Open to participants aged 17 Years to 99 Years. Per ClinicalTrials.gov, last updated 2018-08-06.
Sponsored by Pfizer · Observational
This Investigation is to be performed for the purpose of assessing the following information in the long-term post-marketing daily medical practice in the patients who receive REUMATOLEX 2 mg Capsule for the treatment of Rheumatoid Arthritis (RA) at the dose higher than 8 mg/week.
Implemented as a Special Investigation by Central Registration System
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Patients who receive the MTX Preparation at the dose higher than 8 mg/week for the treatment of Rheumatoid Arthritis.
Exclusion Criteria:
Patients who receive the MTX Preparation at the dose higher than 8 mg/week for the treatment of Rheumatoid Arthritis.
Drug: Methotrexate (MTX)
Methotrexate should be administered at the weekly dose of 6 mg orally once a week or twice or three times a week by subdividing the weekly dose into the relevant number of portions. When administering the subdivided doses, MTX should be administered at the interval of 12 hours on Day 1 to Day 2. When the weekly dose is subdivided into two portions, suspend the administration for the remaining 6 days. When the weekly dose is subdivided into three portions, suspend the administration on the remaining 5 days. Repeat this weekly cycle. The dose should be adjusted as appropriate depending on the age, symptom, tolerability, and response to the MTX Preparation in individual patients. The weekly dose should not be higher than 16 mg.
Also known as: Rheumatrex
Number of Participants With Treatment-Related Adverse Events
A treatment-related adverse event was any untoward medical occurrence attributed to methotrexate in a participant who received methotrexate.
Time frame: 24 Weeks
Disease Activity Score (DAS28)-4ESR
Disease activity score based on 28-joint count and erythrocyte sedimentation rate (4 variables) (DAS28-4 \[ESR\]) was calculated from swollen joint count (SJC) and tender joint count (TJC) using 28 joints count, ESR (mm/hour) and visual analogue scale (VAS) of general health assessed by participant or investigator. Higher score indicated more disease activity. The total scale range of DAS28-4 (ESR) , minimum is 0.0 and maximum can not be specified. DAS28-4 (ESR) \>5.1 indicated high disease activity, ?3.2 to ?5.1 indicated moderate disease activity, \<3.2 indicated low disease activity, and \<2.6 indicated remission.
Time frame: Baseline and 24 Weeks
Disease Activity Score (DAS28)-4CRP
Disease activity score based on 28-joint count and C-reactive protein (4 variables) (DAS28-4 \[CRP\]) was calculated from swollen joint count (SJC) and tender joint count (TJC) using 28 joints count, C-reactive protein (CRP, mg/dL) and VAS of general health. The total scale range of DAS28-4 (ESR) , minimum is 0.0 and maximum can not be specified. DAS28-4 (CRP) \>4.1 indicated high disease activity, ≥2.7 to 4.1 indicated moderate disease activity, \<2.7 indicated low disease activity, and \<2.3 indicated remission.
Time frame: Baseline and 24 Weeks
Change From Baseline in Disease Activity Score (DAS28)-4ESR
Disease activity score based on 28-joint count and erythrocyte sedimentation rate (4 variables) (DAS28-4 \[ESR\]) was calculated from swollen joint count (SJC) and tender joint count (TJC) using 28 joints count, ESR (mm/hour) and visual analogue scale (VAS) of general health assessed by participant or investigator. Mean change from baseline in the DAS28-4 (ESR) at Week 24 is calculated. The total scale range can not be specified.
Time frame: Baseline and 24 Weeks
Change From Baseline in Disease Activity Score (DAS28)-4CRP
Disease activity score based on 28-joint count and C-reactive protein (4 variables) (DAS28-4 \[CRP\]) was calculated from swollen joint count (SJC) and tender joint count (TJC) using 28 joints count, C-reactive protein (CRP, mg/dL) and VAS of general health. Mean change from baseline in the DAS28-4 (CRP) at Week 24 is calculated. The total scale range can not be specified.
Time frame: Baseline and 24 Weeks
Number of Participants With Treatment-Related Serious Adverse Events
A treatment-related adverse event was any untoward medical occurrence attributed to methotrexate in a participant who received methotrexate. A treatment-related serious adverse event was a treatment-related adverse event resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; lifethreatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. Relatedness to methotrexate was assessed by the investigator.
Time frame: 24 Weeks
Number of Participants With Treatment Related Pre-specified Important Serious Adverse Events
Pre-specified important adverse events were 1) Interstitial pneumonia, 2) Pulmonary fibrosis, 3) Hepatic impairment, 4) Renal impairment, 5) Hematopoietic disorder, 6) Infection, and 7) Lymphoma. A treatment-related adverse event was any untoward medical occurrence attributed to methotrexate in a participant who received methotrexate. A treatment-related serious adverse event was a treatment-related adverse event resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; lifethreatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. Relatedness to methotrexate was assessed by the investigator.
Time frame: 24 Weeks
Clinical Efficacy Rate
Clinical efficacy rate, which was defined as the percentage of participants who achieved clinical effectiveness over the total number of assesable effectiveness analysis population, was presented along with the corresponding 2-sided 95% CI. Clinical effectiveness of methotrexate was assessed as "effective" or "ineffective" by the investigator. The assessment was based on the baseline condition of disease control and degree of alleviation from baseline in clinical symptoms and laboratory data.
Time frame: 24 Weeks
| Milestone | Methotrexate |
|---|---|
| Started | 2860 |
| Completed | 2838 |
| Not completed | 22 |
| Withdrew: No visit after first day of treatment | 12 |
| Withdrew: Protocol violation | 10 |
A treatment-related adverse event was any untoward medical occurrence attributed to methotrexate in a participant who received methotrexate.
| Participants | Methotrexate |
|---|---|
| Number of Participants With Treatment-Related Adverse Events | 608 |
Disease activity score based on 28-joint count and erythrocyte sedimentation rate (4 variables) (DAS28-4 \[ESR\]) was calculated from swollen joint count (SJC) and tender joint count (TJC) using 28 joints count, ESR (mm/hour) and visual analogue scale (VAS) of general health assessed by participant or investigator. Higher score indicated more disease activity. The total scale range of DAS28-4 (ESR) , minimum is 0.0 and maximum can not be specified. DAS28-4 (ESR) \>5.1 indicated high disease activity, ?3.2 to ?5.1 indicated moderate disease activity, \<3.2 indicated low disease activity, and \<2.6 indicated remission.
| Score | Methotrexate |
|---|---|
| At Baseline | 4.09 ± 1.235 |
| At 24 Weeks | 3.21 ± 1.235 |
Disease activity score based on 28-joint count and C-reactive protein (4 variables) (DAS28-4 \[CRP\]) was calculated from swollen joint count (SJC) and tender joint count (TJC) using 28 joints count, C-reactive protein (CRP, mg/dL) and VAS of general health. The total scale range of DAS28-4 (ESR) , minimum is 0.0 and maximum can not be specified. DAS28-4 (CRP) \>4.1 indicated high disease activity, ≥2.7 to 4.1 indicated moderate disease activity, \<2.7 indicated low disease activity, and \<2.3 indicated remission.
| Score | Methotrexate |
|---|---|
| At Baseline | 3.55 ± 1.148 |
| At 24 Weeks | 2.66 ± 1.076 |
Disease activity score based on 28-joint count and erythrocyte sedimentation rate (4 variables) (DAS28-4 \[ESR\]) was calculated from swollen joint count (SJC) and tender joint count (TJC) using 28 joints count, ESR (mm/hour) and visual analogue scale (VAS) of general health assessed by participant or investigator. Mean change from baseline in the DAS28-4 (ESR) at Week 24 is calculated. The total scale range can not be specified.
| Score | Methotrexate |
|---|---|
| Change From Baseline in Disease Activity Score (DAS28)-4ESR | -0.88 ± 1.156 |
Disease activity score based on 28-joint count and C-reactive protein (4 variables) (DAS28-4 \[CRP\]) was calculated from swollen joint count (SJC) and tender joint count (TJC) using 28 joints count, C-reactive protein (CRP, mg/dL) and VAS of general health. Mean change from baseline in the DAS28-4 (CRP) at Week 24 is calculated. The total scale range can not be specified.
| Score | Methotrexate |
|---|---|
| Change From Baseline in Disease Activity Score (DAS28)-4CRP | -0.89 ± 1.117 |
A treatment-related adverse event was any untoward medical occurrence attributed to methotrexate in a participant who received methotrexate. A treatment-related serious adverse event was a treatment-related adverse event resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; lifethreatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. Relatedness to methotrexate was assessed by the investigator.
| Participants | Methotrexate |
|---|---|
| Number of Participants With Treatment-Related Serious Adverse Events | 47 |
Pre-specified important adverse events were 1) Interstitial pneumonia, 2) Pulmonary fibrosis, 3) Hepatic impairment, 4) Renal impairment, 5) Hematopoietic disorder, 6) Infection, and 7) Lymphoma. A treatment-related adverse event was any untoward medical occurrence attributed to methotrexate in a participant who received methotrexate. A treatment-related serious adverse event was a treatment-related adverse event resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; lifethreatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. Relatedness to methotrexate was assessed by the investigator.
| Participants | Methotrexate |
|---|---|
| Interstitial Pneumonia | 7 |
| Pulmonary Fibrosis | 0 |
| Hepatic Impairment | 1 |
| Renal Impairment | 1 |
| Hematopoietic Disorder | 3 |
| Infection | 28 |
| Lymphoma | 4 |
Clinical efficacy rate, which was defined as the percentage of participants who achieved clinical effectiveness over the total number of assesable effectiveness analysis population, was presented along with the corresponding 2-sided 95% CI. Clinical effectiveness of methotrexate was assessed as "effective" or "ineffective" by the investigator. The assessment was based on the baseline condition of disease control and degree of alleviation from baseline in clinical symptoms and laboratory data.
| Percentage of Participants | Methotrexate |
|---|---|
| Clinical Efficacy Rate | 80.2 (78.5 to 81.9) |
Non-serious events are listed at a 1.0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Methotrexate | — | 69/2,838 (2.4%) | 340/2,838 (12%) |
| Event | Methotrexate |
|---|---|
| PneumoniaInfections and infestations | 10/2838 |
| Interstitial lung diseaseRespiratory, thoracic and mediastinal disorders | 7/2838 |
| Pneumocystis jirovecii pneumoniaInfections and infestations | 5/2838 |
| LymphomaNeoplasms benign, malignant and unspecified (incl cysts and polyps) | 4/2838 |
| Urinary tract infectionInfections and infestations | 2/2838 |
| Gastric cancerNeoplasms benign, malignant and unspecified (incl cysts and polyps) | 2/2838 |
| Lung neoplasm malignantNeoplasms benign, malignant and unspecified (incl cysts and polyps) | 2/2838 |
| Renal failure acuteRenal and urinary disorders | 2/2838 |
| PyrexiaGeneral disorders | 2/2838 |
| Platelet count decreasedInvestigations | 2/2838 |
| Event | Methotrexate |
|---|---|
| Hepatic function abnormalHepatobiliary disorders | 217/2838 |
| Liver disorderHepatobiliary disorders | 57/2838 |
| StomatitisGastrointestinal disorders | 37/2838 |
| White blood cell count decreasedInvestigations | 29/2838 |
Not in particular
| Age, Customized(Participants) | Methotrexate |
|---|---|
| ≥15 to <65 years | 2014 |
| ≥65 years | 804 |
| Unknown | 20 |
| Sex/Gender, Customized(Participants) | Methotrexate |
|---|---|
| Female | 2176 |
| Male | 659 |
| Unknown | 3 |
| Steinbrocker Stage(Participants) | Methotrexate |
|---|---|
| Stage I (Initial) | 695 |
| Stage II (Medium) | 948 |
| Stage III (Progressive) | 613 |
| Stage IV (Terminal) | 524 |
| Unknown | 58 |
| Steinbrocker Class(Participants) | Methotrexate |
|---|---|
| Class 1 | 794 |
| Class 2 | 1641 |
| Class 3 | 301 |
| Class 4 | 16 |
| Unknown | 86 |
| Morbidity Period(Participants) | Methotrexate |
|---|---|
| <1 year | 443 |
| 1 to ˂3 years | 512 |
| 3 to ˂5 years | 313 |
| ≥5 years | 1148 |
| Unknown | 422 |
| History of Methotrexate Therapy(Participants) | Methotrexate |
|---|---|
| ˂0.5 year | 737 |
| 0.5 to ˂1 year | 254 |
| 1 to ˂3 years | 547 |
| 3 to ˂5 years | 300 |
| ≥5 years | 436 |
| Unknown | 554 |
| Not used Methotrexate Previously | 10 |
This study is completed, as verified in Nov 2017. You cannot join it, but the record below documents what was studied.
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