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Special Investigation on Long-term Treatment in Patients With Rheumatoid Arthritis


N/A
16 Years
N/A
Open (Enrolling)
Both
Rheumatoid Arthritis

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Trial Information

Special Investigation on Long-term Treatment in Patients With Rheumatoid Arthritis


Inclusion Criteria:



- Those who are receiving Humira in accordance with its indications for treatment and
dosage regimens

- Those who are using Humira continuously

- Those with no current and no past history of malignant tumor

- Those evaluable for Disease Activity Score28-4erythrocyte sedimentation rate

- Patients who have been evaluated by Health Assessment Questionnaire or Modified
Health Assessment Questionnaire prior to initiation of Humira treatment (prior to
initial administration of Humira in the all-case survey)

Exclusion Criteria:

- Contraindications according to the Package Insert

- Patients who have serious infections

- Patients who have tuberculosis

- Patients with a history of hypersensitivity to any ingredient of Humira

- Patients who have demyelinating disease or with a history of demyelinating disease

- Patients who have cardiac failure congestive

Type of Study:

Observational

Study Design:

Observational Model: Cohort, Time Perspective: Prospective

Outcome Measure:

Evaluation of adverse event

Outcome Description:

Occurrence of adverse event (yes or no), nature of adverse events, date of onset, seriousness,clinical course of adverse events, outcome, measures, causal relationship between the event and Humira

Outcome Time Frame:

at 1 year

Safety Issue:

Yes

Principal Investigator

Toshiro Maeda

Investigator Role:

Study Director

Investigator Affiliation:

AbbVie GK

Authority:

Japan: Ministry of Health, Labor and Welfare

Study ID:

P12-070

NCT ID:

NCT01163318

Start Date:

December 2009

Completion Date:

December 2013

Related Keywords:

  • Rheumatoid Arthritis
  • Rheumatoid Arthritis
  • Arthritis
  • Arthritis, Rheumatoid

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