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

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. Identifier: NCT01270035
Recruitment Status : Unknown
Verified December 2010 by Keio University.
Recruitment status was:  Recruiting
First Posted : January 5, 2011
Last Update Posted : June 27, 2011
Saitama Medical University
Information provided by:
Keio University

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
Rheumatoid Arthritis Drug: Adalimumab Phase 4

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 40 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Study Start Date : January 2011
Estimated Primary Completion Date : January 2014

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Arthritis
Drug Information available for: Adalimumab

Arm Intervention/treatment
Experimental: ADA 80 mg eow + MTX Drug: Adalimumab
To increase the ADA dose from 40 mg eow to 80 mg eow

Primary Outcome Measures :
  1. The rate of achieving remission at week 30 [ Time Frame: 30 weeks ]

Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Older Adult
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

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 identifier (NCT number): NCT01270035

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

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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

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Responsible Party: Hideto Kameda, Keio University Identifier: NCT01270035    
Other Study ID Numbers: ADA80MTX
First Posted: January 5, 2011    Key Record Dates
Last Update Posted: June 27, 2011
Last Verified: December 2010
Additional relevant MeSH terms:
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Arthritis, Rheumatoid
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases
Connective Tissue Diseases
Autoimmune Diseases
Immune System Diseases
Anti-Inflammatory Agents
Antirheumatic Agents