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| Sponsor: | Charite University, Berlin, Germany |
|---|---|
| Collaborator: |
dfg |
| Information provided by: | Charite University, Berlin, Germany |
| ClinicalTrials.gov Identifier: | NCT00244179 |
Purpose
| Condition | Intervention | Phase |
|---|---|---|
|
Reactive Arthritis |
Drug: interferon-gamma Drug: infliximab Drug: dmard |
Phase II |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Educational/Counseling/Training |
| Official Title: | New Immunomodulatory Therapy Strategies in Chronic Reactive Arthritis: Immunostimulation Plus Antibiotic Versus Immunosuppression Plus Antibiotic Versus Conventional Standardtherapy |
| Estimated Enrollment: | 40 |
| Study Start Date: | January 2003 |
Show Detailed Description
Eligibility| Ages Eligible for Study: | 18 Years to 70 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
definite classification of the arthritis as ReA enteric ReA is defined as an arthritis, which occurs within 4 weeks after a preceding symptomatic infection of the gut with enteric bacteria such as yersinia, salmonella, campylobacter jejuni, shigella. If no symptomatic preceding infection can be remembered the triggering enterobacterium has to be clearly identified by serology or stool culture. Other causes for a diarrhea like for example inflammatory bowel disease have to be eliminated.
urogenital (chlamydia-triggered) ReA is defined as an arthritis, which occurs within 4 weeks after a symptomatic urogenital infection or an infection of the upper airways or if chlamydia can be clearly identified be serology or direct proof.
Exclusion Criteria:
Contacts and Locations| Contact: joachim sieper, prof. | 0049 30 8445 ext 4414 | joachim.sieper@charite.de |
| Contact: henning c brandt, md | 0049 30 8445 ext 4414 | henning.brandt@charite.de |
| Germany | |
| Charite Campus Benjamin Franklin, Rheumatology | Recruiting |
| Berlin, Germany, 12200 | |
| Contact: joachim sieper, prof. 0049 30 8445 ext 4414 joachim.sieper@charite.de | |
| Contact: henning c brandt, md 0049 30 8445 ext 4414 henning.brandt@charite.de | |
| Principal Investigator: joachim sieper, prof | |
| Sub-Investigator: henning c brandt, md | |
| Sub-Investigator: hildrun haibel, md | |
| Sub-Investigator: in-ho song, md | |
| Sub-Investigator: Martin Rudwaleit, MD | |
| Principal Investigator: | joachim sieper, prof. | charite, campus benjamin franklin, rheumatology, berlin |
More Information
| ClinicalTrials.gov Identifier: | NCT00244179 History of Changes |
| Other Study ID Numbers: | ReA01 |
| Study First Received: | October 24, 2005 |
| Last Updated: | September 7, 2006 |
| Health Authority: | Germany: Federal Institute for Drugs and Medical Devices; Germany: Paul-Ehrlich-Institut |
|
reactive arthritis trial interferon-gamma |
infliximab chronic tnf-blocker |
|
Arthritis Arthritis, Reactive Joint Diseases Musculoskeletal Diseases Arthritis, Infectious Infection Spondylarthropathies Spondylarthritis Spondylitis Spinal Diseases Bone Diseases Interferon-gamma |
Interferon-gamma, Recombinant Interferons Infliximab Antirheumatic Agents Antiviral Agents Anti-Infective Agents Therapeutic Uses Pharmacologic Actions Antineoplastic Agents Dermatologic Agents Gastrointestinal Agents Anti-Inflammatory Agents |