Efficacy and Safety of Adalimumab 80 mg Every Other Week With Methotrexate
Sponsor
Keio University (Other)
Overall Status
Unknown status
CT.gov ID
NCT01270035
Collaborator
Saitama Medical University (Other)
40
2
1
20
Study Details
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
| Phase 4 |
Study Design
Study Type:
Interventional
Anticipated Enrollment
:
40 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Study Start Date
:
Jan 1, 2011
Anticipated Primary Completion Date
:
Jan 1, 2014
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: ADA 80 mg eow + MTX
|
Drug: Adalimumab
To increase the ADA dose from 40 mg eow to 80 mg eow
|
Outcome Measures
Primary Outcome Measures
- The rate of achieving remission at week 30 [30 weeks]
Eligibility Criteria
Criteria
Ages Eligible for Study:
N/A
and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Saitama Medical Center | Kawagoe | Saitama | Japan | 350-8550 |
| 2 | Keio University Hospital | Shinanomachi | Tokyo | Japan | 160-8582 |
Sponsors and Collaborators
- Keio University
- Saitama Medical University
Investigators
None specified.Study Documents (Full-Text)
None provided.More Information
Publications
None provided.Responsible Party:
,
,
ClinicalTrials.gov Identifier:
NCT01270035
Other Study ID Numbers:
- ADA80MTX
First Posted:
Jan 5, 2011
Last Update Posted:
Jun 27, 2011
Last Verified:
Dec 1, 2010