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Trial record 1 of 1 for:    NCT01414257
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Methotrexate (Rheumatrex) High Dose Special Investigation (Regulatory Post Marketing Commitment Plan)

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ClinicalTrials.gov Identifier: NCT01414257
Recruitment Status : Completed
First Posted : August 11, 2011
Results First Posted : August 6, 2018
Last Update Posted : August 6, 2018
Sponsor:
Information provided by (Responsible Party):
Pfizer

Tracking Information
First Submitted Date August 9, 2011
First Posted Date August 11, 2011
Results First Submitted Date January 9, 2017
Results First Posted Date August 6, 2018
Last Update Posted Date August 6, 2018
Actual Study Start Date May 2011
Actual Primary Completion Date March 2014   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: November 8, 2017)
  • Number of Participants With Treatment-Related Adverse Events [ Time Frame: 24 Weeks ]
    A treatment-related adverse event was any untoward medical occurrence attributed to methotrexate in a participant who received methotrexate.
  • Disease Activity Score (DAS28)-4ESR [ Time Frame: Baseline and 24 Weeks ]
    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.
  • Disease Activity Score (DAS28)-4CRP [ Time Frame: Baseline and 24 Weeks ]
    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.
  • Change From Baseline in Disease Activity Score (DAS28)-4ESR [ Time Frame: Baseline and 24 Weeks ]
    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.
  • Change From Baseline in Disease Activity Score (DAS28)-4CRP [ Time Frame: Baseline and 24 Weeks ]
    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.
Original Primary Outcome Measures
 (submitted: August 9, 2011)
Disease Activity Score (DAS28)-4ESR/4CRP [ Time Frame: 24 Weeks ]
Change History Complete list of historical versions of study NCT01414257 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures
 (submitted: November 8, 2017)
  • Number of Participants With Treatment-Related Serious Adverse Events [ Time Frame: 24 Weeks ]
    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.
  • Number of Participants With Treatment Related Pre-specified Important Serious Adverse Events [ Time Frame: 24 Weeks ]
    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.
  • Clinical Efficacy Rate [ Time Frame: 24 Weeks ]
    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.
Original Secondary Outcome Measures
 (submitted: August 9, 2011)
Assess clinical efficacy to 2 levels; "effective" or "ineffective" based on the degree of alleviation of RA and laboratory data [ Time Frame: 24 Weeks ]
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Methotrexate (Rheumatrex) High Dose Special Investigation (Regulatory Post Marketing Commitment Plan)
Official Title Rheumatrex High Dose Special Investigation (Regulatory Post Marketing Commitment Plan)
Brief Summary

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.

  1. Condition of occurrence of ADRs
  2. Factors considered to affect safety
  3. Verification of efficacy
Detailed Description Implemented as a Special Investigation by Central Registration System
Study Type Observational
Study Design Observational Model: Case-Only
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
Sampling Method Probability Sample
Study Population Patients who receive the MTX Preparation at the dose higher than 8 mg/week for the treatment of Rheumatoid Arthritis.
Condition
  • Arthritis
  • Rheumatoid
  • High Dose
Intervention 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.
Other Name: Rheumatrex
Study Groups/Cohorts Methotrexate (MTX)
Patients who receive the MTX Preparation at the dose higher than 8 mg/week for the treatment of Rheumatoid Arthritis.
Intervention: Drug: Methotrexate (MTX)
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Completed
Actual Enrollment
 (submitted: November 8, 2017)
2860
Original Estimated Enrollment
 (submitted: August 9, 2011)
3000
Actual Study Completion Date March 2014
Actual Primary Completion Date March 2014   (Final data collection date for primary outcome measure)
Eligibility Criteria

Inclusion Criteria:

  • Patients need to be administered Rheumatrex in order to be enrolled in the survey
  • Patients who receive the Rheumatrex at the dose higher than 8 mg/week for the treatment of Rheumatoid Arthritis

Exclusion Criteria:

  • Patients who have been treated with Rheumatrex at the dose higher than 8 mg/week since the days when the high dose therapy for RA was not approved
  • Patients who have been treated MTX other than Rheumatrex administered Rheumatrex
Sex/Gender
Sexes Eligible for Study: All
Ages 17 Years to 99 Years   (Child, Adult, Older Adult)
Accepts Healthy Volunteers No
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries Japan
Removed Location Countries  
 
Administrative Information
NCT Number NCT01414257
Other Study ID Numbers B3211003
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement Not Provided
Responsible Party Pfizer
Study Sponsor Pfizer
Collaborators Not Provided
Investigators
Study Director: Pfizer CT.gov Call Center Pfizer
PRS Account Pfizer
Verification Date November 2017