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

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified December 2010 by Keio University.
Recruitment status was:  Recruiting
ClinicalTrials.gov Identifier:
First Posted: January 5, 2011
Last Update Posted: June 27, 2011
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Saitama Medical University
Information provided by:
Keio University
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: None (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 ]

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


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Ages Eligible for Study:   Child, Adult, Senior
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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01270035

Contact: Hideto Kameda, MD. PhD +81-3-5843-6179 kamehide@z6.keio.jp

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

Responsible Party: Hideto Kameda, Keio University
ClinicalTrials.gov Identifier: NCT01270035     History of Changes
Other Study ID Numbers: ADA80MTX
First Submitted: January 4, 2011
First Posted: January 5, 2011
Last Update Posted: June 27, 2011
Last Verified: December 2010

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