Efficacy and Safety of Adalimumab 80 mg Every Other Week With Methotrexate

NCT ID: NCT01270035

Last Updated: 2011-06-27

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE4

Total Enrollment

40 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-01-31

Brief Summary

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In Japan, as well as in other countries, the dose of adalimumab (ADA) is limited to 40 mg every other week when used in combination with methotrexate (MTX) for patients with rheumatoid arthritis (RA). However, ADA 80 mg with MTX may be required for some RA patients, especially for those with high disease activity. Therefore, we tried to increase the ADA dose to 80 mg every other week with concomitant MTX, only if the disease activity did not decrease below moderate activity defined by DAS28 \< 3.2. The primary endpoint was the rate of patients who achieved disease remission (DAS28 \< 2.6) at 30 weeks with this predifined treatment strategy.

Detailed Description

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Conditions

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Rheumatoid Arthritis

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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ADA 80 mg eow + MTX

Group Type EXPERIMENTAL

Adalimumab

Intervention Type DRUG

To increase the ADA dose from 40 mg eow to 80 mg eow

Interventions

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Adalimumab

To increase the ADA dose from 40 mg eow to 80 mg eow

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* patients with rheumatoid arthritis receiving MTX ≧ 6 mg/week for at least 3 months disease activity : DAS28 \> 5.1

Exclusion Criteria

* allergy to ADA present active infection including TB history of demyelinating disease, HBV infection and malignancy
Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Saitama Medical University

OTHER

Sponsor Role collaborator

Keio University

OTHER

Sponsor Role lead

Responsible Party

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Keio University

Locations

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Saitama Medical Center

Kawagoe, Saitama, Japan

Site Status NOT_YET_RECRUITING

Keio University Hospital

Shinanomachi, Tokyo, Japan

Site Status RECRUITING

Countries

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Japan

Central Contacts

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Hideto Kameda, MD. PhD

Role: CONTACT

+81-3-5843-6179

Facility Contacts

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Koichi Amano

Role: primary

Hideto Kameda

Role: primary

Other Identifiers

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ADA80MTX

Identifier Type: -

Identifier Source: org_study_id

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