Efficacy and Safety of Adalimumab 80 mg Every Other Week With Methotrexate
This study is currently recruiting participants.
Verified December 2010 by Keio University
Sponsor:
Keio University
Collaborator:
Saitama Medical University
Information provided by:
Keio University
ClinicalTrials.gov Identifier:
NCT01270035
First received: January 4, 2011
Last updated: June 23, 2011
Last verified: December 2010
- Full Text View
- Tabular View
- No Study Results Posted
- Disclaimer
- How to Read a Study Record
Purpose
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 | Intervention | Phase |
|---|---|---|
|
Rheumatoid Arthritis |
Drug: Adalimumab |
Phase 4 |
| Study Type: | Interventional |
| Study Design: | Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment |
Resource links provided by NLM:
MedlinePlus related topics:
Rheumatoid Arthritis
Drug Information available for:
Adalimumab
U.S. FDA Resources
Further study details as provided by Keio University:
Primary Outcome Measures:
- The rate of achieving remission at week 30 [ Time Frame: 30 weeks ] [ Designated as safety issue: No ]
| Estimated Enrollment: | 40 |
| Study Start Date: | January 2011 |
| Estimated Primary Completion Date: | January 2014 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
| Experimental: ADA 80 mg eow + MTX |
Drug: Adalimumab
To increase the ADA dose from 40 mg eow to 80 mg eow
|
Eligibility| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
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
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01270035
Contacts
| Contact: Hideto Kameda, MD. PhD | +81-3-5843-6179 | kamehide@z6.keio.jp |
Locations
| Japan | |
| Saitama Medical Center | Not yet recruiting |
| Kawagoe, Saitama, Japan, 350-8550 | |
| Contact: Koichi Amano amanokoi@saitama-med.ac.jp | |
| Keio University Hospital | Recruiting |
| Shinanomachi, Tokyo, Japan, 160-8582 | |
| Contact: Hideto Kameda kamehide@z6.keio.jp | |
Sponsors and Collaborators
Keio University
Saitama Medical University
More Information
No publications provided
| Responsible Party: | Hideto Kameda, Keio University |
| ClinicalTrials.gov Identifier: | NCT01270035 History of Changes |
| Other Study ID Numbers: | ADA80MTX |
| Study First Received: | January 4, 2011 |
| Last Updated: | June 23, 2011 |
| Health Authority: | Japan: Institutional Review Board |
Additional relevant MeSH terms:
|
Arthritis Arthritis, Rheumatoid Joint Diseases Musculoskeletal Diseases Rheumatic Diseases Connective Tissue Diseases Autoimmune Diseases |
Immune System Diseases Adalimumab Antirheumatic Agents Therapeutic Uses Pharmacologic Actions Anti-Inflammatory Agents |
ClinicalTrials.gov processed this record on May 22, 2013