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

Rheumatoid Arthritis Clinical Trial

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01270035
• Other study ID #: ADA80MTX
• Status: Recruiting
• Phase: Phase 4
• First received: January 4, 2011
• Last updated: June 23, 2011
• Start date: January 2011

Study information

• Verified date: December 2010
• Source: Keio University
• Contact: Hideto Kameda, MD. PhD
• Phone: +81-3-5843-6179
• Email: kamehide[@]z6.keio.jp
• Is FDA regulated: No
• Health authority: Japan: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 40
• Est. primary completion date: January 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A and older

Eligibility

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

Study Design

Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Arthritis, Rheumatoid
• Rheumatoid Arthritis

Intervention

Drug:
• Adalimumab
To increase the ADA dose from 40 mg eow to 80 mg eow

Locations

Country	Name	City	State
Japan	Saitama Medical Center	Kawagoe	Saitama
Japan	Keio University Hospital	Shinanomachi	Tokyo

Sponsors (2)

Lead Sponsor	Collaborator
Keio University	Saitama Medical University

Country where clinical trial is conducted

Japan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The rate of achieving remission at week 30		30 weeks	No