Registry of Japanese Rheumatoid Arthritis Patients on Biologics for Long-term Safety (REAL)

Registry of Japanese Rheumatoid Arthritis Patients on Biologics for Long-term Safety (REAL) - Registry of Japanese Rheumatoid Arthritis patients for Long-term Safety

Status

Active, not recruiting

Phases

Unknown

Study type

Observational

Source

JPRN

Registry ID

JPRN-UMIN000001222

Enrollment

2000

Registered

2008-08-01

Start date

2005-05-01

Completion date

Unknown

Last updated

2026-06-29

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

Conditions

rheumatoid arthritis

Interventions

None listed

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: Patients must meet the following criteria to be eligible for study entry: 1. Fulfill the 1987 American College of Rheumatology criteria. 2. Patients (age > 20) should have ability and willingness to provide written informed consent and to comply with the requirement of the protocol. 3. Parents of patients (age < 20) should have ability and willingness to provide written informed consent and to comply with the requirement of the protocol. 4. Have started treatment with biologics or non-biological disease modifying anti-rheumatic drug within last six months and are still receiving these treatments at study entry. # Until December 2006, patients who had been continuing treatment with non-biological disease modifying anti-rheumatic drugs more than 6 months at study entry were also enrolled. # Biologics in this study include infliximab, etanercept, tocilizumab and adalimumab as of June 2008, but other drugs will also be included after their approval in Japan.

Exclusion criteria

Exclusion criteria: A patient who has any of the following will be excluded from the study. 1. When a patient is participating in a clinical trial for approval of drugs (i.e., chiken) at the enrollment. 2. When a patient is regarded as inappropriate to join the study based on medical reasons or other rational reasons. 3. When a patient refuses to join the study or withdraw his or her consent. 4. When it is revealed that a patient did not satisfy the inclusion criteria at the enrollment or satisfies one of the exclusion criteria at the enrollment.

Design outcomes

Primary

Measure	Time frame
Incidence rate of serious adverse events.	—

Secondary

Measure	Time frame
Type of serious adverse events, long term prognosis, death rates.	—

Countries

Japan

Contacts

Public ContactMasayoshi Harigai

REAL study headquarters Tokyo Medical and Dental University, Department of Pharmacovigilance

mharigai.mpha@tmd.ac.jp03-5803-4677

Outcome results