ArthritisNCT01414257

Methotrexate (Rheumatrex) High Dose Special Investigation (Regulatory Post Marketing Commitment Plan)

An observational study of Arthritis and Rheumatoid, run by Pfizer at 1 site in Japan.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Trial 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. Read more about this study

Who is it for?: Ages 17 to 99 years
Conditions the study is for: Arthritis, Rheumatoid, High Dose
What is being tested?: Methotrexate (MTX)
Type of treatment: Pill or oral medicine
How many people: 2,860 participants
Where: 1 siteJapan
Study dates: May 2011to Mar 2014
Phase: Observational
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 17 to 99 years
All sexes
No healthy volunteers
Child, Adult, Older adult

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

Who may be able to join

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

Who cannot join

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

Trial locations and contacts

1 site in 1 country.

Japan1 site

University of Occupational and Environmental Health Hospital
Kitakyushu-shi, Fukuoka

Other trials in Japan

About this study

Official title: Rheumatrex High Dose Special Investigation (Regulatory Post Marketing Commitment Plan)

Condition of occurrence of ADRs
Factors considered to affect safety
Verification of efficacy

Read the detailed description

Implemented as a Special Investigation by Central Registration System

Conditions: Arthritis, Rheumatoid, High Dose
Being tested: Methotrexate (MTX)
Keywords: Rheumatrex, High Dose
Medical subject headings: Arthritis

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Methotrexate (MTX)Drug
Also called Rheumatrex
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.

Study groups in NCT01414257
Study group	Role	What they receive
Methotrexate (MTX)		Patients who receive the MTX Preparation at the dose higher than 8 mg/week for the treatment of Rheumatoid Arthritis. Receives: Drug: Methotrexate (MTX)

What is being measured

The primary outcome is the main question the study is designed to answer.

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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Baseline and 24 Weeks

Secondary outcomes (3)

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.
Measured: 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.
Measured: 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.
Measured: 24 Weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

May 2011Mar 2014

First posted11 Aug 2011 (estimated)
Study startMay 2011
Primary completionMar 2014
Study completionMar 2014

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for ArthritisStudies of the same condition, open and under way.
More trials run by PfizerThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Observational
Observational model: Case only
Time perspective: Prospective
Enrolment: 2,860 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01414257
Sponsor's protocol ID: B3211003
Status last verified: Nov 2017
First submitted: 9 Aug 2011
Last updated: 6 Aug 2018
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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RecruitingPhase 2
Study of PTC844 in Participants With Active Rheumatoid Arthritis
Rheumatoid Arthritis
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An Ascending Dose Study of DKB903 in Participants With Rheumatoid Arthritis (RA) and Participants With Systemic Lupus Erythematosus (SLE)
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All Arthritis trials

Study at a glance

From the registry record, last updated by the sponsor on 6 Aug 2018. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Rheumatrex High Dose Special Investigation (Regulatory Post Marketing Commitment Plan)
ClinicalTrials.gov ID: NCT01414257
Acronym / sponsor ID: B3211003
Conditions: Arthritis, Rheumatoid, High Dose
Keywords: Rheumatrex, High Dose
Study type: Observational
Recruitment status: Completed
Enrolment: 2,860 participants (actual)
Lead sponsor: PfizerIndustry (pharma, biotech, devices)
Study start: May 2011 (actual)
Primary completion: Mar 2014 (actual)
Study completion: Mar 2014 (actual)
First posted: 11 Aug 2011 (estimated)
Results: Posted 6 Aug 2018

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Condition of occurrence of ADRs
Factors considered to affect safety
Verification of efficacy

Detailed description

Implemented as a Special Investigation by Central Registration System

Study design

Observational model: Case only
Time perspective: Prospective
Number of arms: 1

Arm	Type	Receives
Methotrexate (MTX)	–	Drug: Methotrexate (MTX)Patients who receive the MTX Preparation at the dose higher than 8 mg/week for the treatment of Rheumatoid Arthritis.

Who may qualify

Ages: 17 to 99 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Child, Adult, Older adult
Study population: Patients who receive the MTX Preparation at the dose higher than 8 mg/week for the treatment of Rheumatoid Arthritis.

Key inclusion criteria (2 listed)

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

Key exclusion criteria (2 listed)

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

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Methotrexate (MTX)Also: RheumatrexMethotrexate 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.	Drug	Methotrexate (MTX)

Primary outcome

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.

3 secondary outcomes

Number of Participants With Treatment-Related Serious Adverse Events
Time frame: 24 Weeks
Number of Participants With Treatment Related Pre-specified Important Serious Adverse Events
Time frame: 24 Weeks
Clinical Efficacy Rate
Time frame: 24 Weeks

Results and safety

Results posted to the registry on 6 Aug 2018, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Methotrexate	2,860	2,838

Primary outcome: Number of Participants With Treatment-Related Adverse Events

Time frame: 24 Weeks. Number. Unit: Participants

Measure	Methotrexate n = 2838
Value	608

Population analysed: The safety analysis set comprised of participants who satisfied the inclusion criteria and had received methotrexate at least once.

Primary outcome: Disease Activity Score (DAS28)-4ESR

Time frame: Baseline and 24 Weeks. Mean (Standard Deviation). Unit: Score

Measure	Methotrexate n = 1526
At Baseline	4.09 (1.235)
At 24 Weeks	3.21 (1.235)

Population analysed: The effectiveness analysis set comprised of participants in the safety analysis set who had effectiveness evaluation (ESR) at least once. Participants with observed DAS28-4(ESR) were included in table.

Primary outcome: Disease Activity Score (DAS28)-4CRP

Time frame: Baseline and 24 Weeks. Mean (Standard Deviation). Unit: Score

Measure	Methotrexate n = 1818
At Baseline	3.55 (1.148)
At 24 Weeks	2.66 (1.076)

Population analysed: The effectiveness analysis set comprised of participants in the safety analysis set who had effectiveness evaluation (CRP) at least once. Participants with observed DAS28-4(CRP) were included in table.

Primary outcome: Change From Baseline in Disease Activity Score (DAS28)-4ESR

Time frame: Baseline and 24 Weeks. Mean (Standard Deviation). Unit: Score

Measure	Methotrexate n = 1526
Value	-0.88 (1.156)

3 secondary outcomes are reported in the full results.

Adverse events

Other adverse events reported at 1.0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Methotrexate	69 of 2,838 (2.4%)	340 of 2,838 (12%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 6 Aug 2018.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
To obtain contact information for a study center near you, click here.Link provided by the sponsor.

Related trials for Arthritis

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Study of PTC844 in Participants With Active Rheumatoid Arthritis
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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Pfizer CT.gov Call Center study director

Pfizer

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

An observational study of Arthritis and Rheumatoid, run by Pfizer at 1 site in Japan.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 2 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 6 Aug 2018. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Japan. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 6 Aug 2018). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Number of Participants With Treatment-Related Adverse Events (time frame: 24 Weeks). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01414257.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Aug 2018.