Back to resultsEfficacy and Safety of Adalimumab 80 mg Every Other Week With Methotrexate
Primary Purpose
Rheumatoid Arthritis
Status
Unknown status
Phase
Phase 4
Locations
Japan
Study Type
Interventional
Intervention
Adalimumab
Sponsored by
About this trial
This is an interventional treatment trial for Rheumatoid Arthritis
Eligibility Criteria
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
Sites / Locations
- Saitama Medical Center
- Keio University HospitalRecruiting
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
ADA 80 mg eow + MTX
Arm Description
Outcomes
Primary Outcome Measures
The rate of achieving remission at week 30
Secondary Outcome Measures
Full Information
NCT ID
NCT01270035
First Posted
January 4, 2011
Last Updated
June 23, 2011
Sponsor
Keio University
Collaborators
Saitama Medical University
1. Study Identification
Unique Protocol Identification Number
NCT01270035
Brief Title
Efficacy and Safety of Adalimumab 80 mg Every Other Week With Methotrexate
Study Type
Interventional
2. Study Status
Record Verification Date
December 2010
Overall Recruitment Status
Unknown status
Study Start Date
January 2011 (undefined)
Primary Completion Date
January 2014 (Anticipated)
Study Completion Date
undefined (undefined)
3. Sponsor/Collaborators
Name of the Sponsor
Keio University
Collaborators
Saitama Medical University
4. Oversight
5. Study Description
Brief Summary
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Rheumatoid Arthritis
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
40 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
ADA 80 mg eow + MTX
Arm Type
Experimental
Intervention Type
Drug
Intervention Name(s)
Adalimumab
Intervention Description
To increase the ADA dose from 40 mg eow to 80 mg eow
Primary Outcome Measure Information:
Title
The rate of achieving remission at week 30
Time Frame
30 weeks
10. Eligibility
Sex
All
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Hideto Kameda, MD. PhD
Phone
+81-3-5843-6179
Email
kamehide@z6.keio.jp
Facility Information:
Facility Name
Saitama Medical Center
City
Kawagoe
State/Province
Saitama
ZIP/Postal Code
350-8550
Country
Japan
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Koichi Amano
Email
amanokoi@saitama-med.ac.jp
Facility Name
Keio University Hospital
City
Shinanomachi
State/Province
Tokyo
ZIP/Postal Code
160-8582
Country
Japan
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Hideto Kameda
Email
kamehide@z6.keio.jp
12. IPD Sharing Statement
Learn more about this trial
Efficacy and Safety of Adalimumab 80 mg Every Other Week With Methotrexate
We'll reach out to this number within 24 hrs