NCT01414257

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. 1.Condition of occurrence of ADRs
  2. 2.Factors considered to affect safety
  3. 3.Verification of efficacy

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
2,860

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started May 2011

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 1, 2011

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

August 9, 2011

Completed
2 days until next milestone

First Posted

Study publicly available on registry

August 11, 2011

Completed
2.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2014

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2014

Completed
4.4 years until next milestone

Results Posted

Study results publicly available

August 6, 2018

Completed
Last Updated

August 6, 2018

Status Verified

November 1, 2017

Enrollment Period

2.8 years

First QC Date

August 9, 2011

Results QC Date

January 9, 2017

Last Update Submit

November 8, 2017

Conditions

ArthritisRheumatoidHigh Dose

Keywords

RheumatrexHigh Dose

Outcome Measures

Primary Outcomes (5)

  • 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.

    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.

    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.

    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.

    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.

    Baseline and 24 Weeks

Secondary Outcomes (3)

  • Number of Participants With Treatment-Related Serious Adverse Events

    24 Weeks

  • Number of Participants With Treatment Related Pre-specified Important Serious Adverse Events

    24 Weeks

  • Clinical Efficacy Rate

    24 Weeks

Study Arms (1)

Methotrexate (MTX)

Patients who receive the MTX Preparation at the dose higher than 8 mg/week for the treatment of Rheumatoid Arthritis.

Drug: Methotrexate (MTX)

Interventions

Methotrexate (MTX)DRUG

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
Methotrexate (MTX)

Eligibility Criteria

Age17 Years - 99 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

Patients who receive the MTX Preparation at the dose higher than 8 mg/week for the treatment of Rheumatoid Arthritis.

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Occupational and Environmental Health Hospital

Kitakyushu-shi, Fukuoka, Japan

Location

Related Links

MeSH Terms

Conditions

Arthritis

Interventions

Methotrexate

Condition Hierarchy (Ancestors)

Joint DiseasesMusculoskeletal Diseases

Intervention Hierarchy (Ancestors)

AminopterinPterinsPteridinesHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-RingHeterocyclic Compounds

Results Point of Contact

Title
Pfizer ClinicalTrials.gov Call Center
Organization
Pfizer, Inc.
ClinicalTrials.gov_Inquiries@pfizer.com
1-800-718-1021

Study Officials

  • Pfizer CT.gov Call Center

    Pfizer

    STUDY DIRECTOR

Publication Agreements

PI is Sponsor Employee
No
Restriction Type
OTHER
Restrictive Agreement
Yes

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
PROSPECTIVE
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 9, 2011

First Posted

August 11, 2011

Study Start

May 1, 2011

Primary Completion

March 1, 2014

Study Completion

March 1, 2014

Last Updated

August 6, 2018

Results First Posted

August 6, 2018

Record last verified: 2017-11

Locations

JP(1)