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Effect of diease-modifying and biological drugs on intestinal immunity in patients with rheumatoid arthritis.

Effect of diease-modifying and biological drugs on intestinal immunity in patients with rheumatoid arthritis. - Anti-rheumatic drugs, biologicals and intestinal immunity.

Status
Recruiting
Phases
Phase 4
Study type
Observational
Source
JPRN
Registry ID
JPRN-UMIN000012200
Enrollment
80
Registered
2013-11-01
Start date
2013-11-01
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

Sponsors

Katayama Orthopadic Rheumatology Clinic
Lead Sponsor
Chondrex Inc. Asama-chemical Co. Ltd. Seien Drugs Compounding Co. Ltd
Collaborator

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: Three groups of RA patients of each consisting of 20 and more persons will be studied for at least 6 months. A group ofhealthy persons will be addopted as a control. 1) Untreated RA patients, before and after treatment with DMARDs. 2) RA patients during treatment with DMARs. 3) DMARDs resistant RA patient, before and after treatement with biologicals. 4) Normal adults

Exclusion criteria

Exclusion criteria: RA patients having complication other than rheumatoid arthritis

Design outcomes

Primary

MeasureTime frame
a) Therapeutic effects of DMARDs and biologicals will be evaluated by EULAR and ACR criteria. b) Antibody response to E. coli and LPS will be assayed to determine intestinal immune function of individual pateints, whereas serum LPS levels will be determined to measure intestinal barrier function. In addition, serum TNF, IL-6 and anti-CCP antibody levels will be assayed to study the potential linkage between intestinal immune function and inflamation. c) Effect of RMARDs and biologicals on intestinal immune function will be evaluated in individual patients for a 6-month period as well as for their their therapeutic effect.

Secondary

MeasureTime frame
This study will provide basic data to study a new concept that lowered immune function may be the fundamental common disorder in autoimmune diseases.

Countries

Japan

Contacts

Public ContactKou Katayama

Katayama Orthopedic Rheumatology Clinic Department of orthopedic surgery

kou@kata-rheum.or.jp0166-39-1155

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026