Now Available: Final Rule for FDAAA 801 and NIH Policy on Clinical Trial Reporting

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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified December 2010 by Keio University.
Recruitment status was  Recruiting
Saitama Medical University
Information provided by:
Keio University Identifier:
First received: January 4, 2011
Last updated: June 23, 2011
Last verified: December 2010
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:

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


Ages Eligible for Study:   Child, Adult, Senior
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT01270035

Contact: Hideto Kameda, MD. PhD +81-3-5843-6179

Saitama Medical Center Not yet recruiting
Kawagoe, Saitama, Japan, 350-8550
Contact: Koichi Amano   
Keio University Hospital Recruiting
Shinanomachi, Tokyo, Japan, 160-8582
Contact: Hideto Kameda   
Sponsors and Collaborators
Keio University
Saitama Medical University
  More Information

Responsible Party: Hideto Kameda, Keio University 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, Rheumatoid
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases
Connective Tissue Diseases
Autoimmune Diseases
Immune System Diseases
Anti-Inflammatory Agents
Antirheumatic Agents processed this record on October 25, 2016