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

Status

UNKNOWN

Phases

Phase 4

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01270035

Enrollment

Registered

2011-01-05

Start date

2011-01-31

Completion date

Unknown

Last updated

2011-06-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Rheumatoid Arthritis

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.

Interventions

DRUGAdalimumab

To increase the ADA dose from 40 mg eow to 80 mg eow

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame
The rate of achieving remission at week 30	30 weeks

Countries

Japan

Contacts

Primary ContactHideto Kameda, MD. PhD

kamehide@z6.keio.jp+81-3-5843-6179

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026