New Immunomodulatory Therapy Strategies in Chronic Reactive Arthritis

The recruitment status of this study is unknown because the information has not been verified recently.
Verified September 2006 by Charite University, Berlin, Germany.
Recruitment status was  Recruiting
Sponsor:
Collaborator:
dfg
Information provided by:
Charite University, Berlin, Germany
ClinicalTrials.gov Identifier:
NCT00244179
First received: October 24, 2005
Last updated: September 7, 2006
Last verified: September 2006
  Purpose
  1. to investigate, whether one of the two alternative therapy strategies (antibiotic plus immunostimulation versus antibiotic plus immunosuppression) in chronic reactive arthritis is therapeutical superior to conventionel standardtherapy (DMARD).
  2. to investigate, whether one or more of the different therapy strategies cause an altered detection of bacterial DNA in the joint or colon.
  3. to measure the antigen-specific and -unspecific immune response (predominantly t-cell response) during therapy and correlate it with the clinical course.
  4. to gain knowledge from these analyses and the clinical course concerning the pathogenesis and the point of attack for possible therapies in chronic reactive arthritis.
  5. to compare cytokine-profiles of CD4- and CD8-positive T-cells from patients treated with infliximab to those treated with etanercept.

Condition Intervention Phase
Reactive Arthritis
Drug: interferon-gamma
Drug: infliximab
Drug: dmard
Phase 2

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

Resource links provided by NLM:


Further study details as provided by Charite University, Berlin, Germany:

Primary Outcome Measures:
  • change in intensity of pain (VAS pain, scale 0-10)
  • change in funcion (WOMAC)

Secondary Outcome Measures:
  • decrease of CRP/ESR
  • change of cytokine response
  • change of DNA detection
  • number of swollen and tender joints
  • number of entheseal localisations
  • improvement of quality of life, „Short form 36“ (SF-36)
  • BASDAI (disease activity index)
  • Reduction of NSAIDs
  • Patient`s global (scale 0-10).
  • Physician`s global (scale 0-10).

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
Criteria

Inclusion Criteria:

  1. 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.

  2. disease duration > 12 months
  3. age 18 to 70 years
  4. active arthritis in at least one joint
  5. constant demand of NSAIDs
  6. intensity of pain > 4 on a visual analogue scale (VAS; 0 to 10)
  7. patients are allowed to have been treated with so-called conventional therapy (Sulphasalazine, Methotrexate etc.) or steroids i.a. before, but they have to be stopped 4 weeks before enrolled into the trial
  8. able to self-administer s.c. injections or have a caregiver who will do so
  9. women of child bearing potential must have a negative pregnancy test at study baseline and use an adequate, effective method of contraception (such as implants, injectables, combined oral contraceptives, some IUDs, sexual abstinence, vasectomised partner) for a duration of 6 months after stop of therapy. Sexual active men must use an accepted method of contraception for a duration of 6 months after stop of therapy.
  10. reading a normal chest/ lung x-ray, negative Mendel-Mantoux-skin test (10,0 TE) (both not older than 4 weeks). If Mendel-Mantoux-skin test is positive and / or there are hints for a healed up tuberculosis in the chest x-ray (latent tuberculosis) and the patient shall receive infliximab or etanercept an additional therapy with isoniazid 300 mg daily starting 4 weeks before first administration of infliximab or etanercept has to be given.
  11. signed informed consent

Exclusion Criteria:

  1. female subjects who are pregnant or breast-feeding
  2. previous treatment with cytokines or anti-cytokines (biological agents)
  3. severe infections within the last 3 months
  4. history of opportunistic infections within the last 2 months (herpes zoster, cytomegaly virus-, pneumocystis carinii-infection)
  5. HIV-infection
  6. history of malignancy
  7. receipt of any live (attenuated) vaccines within last 30 days before screening visit
  8. previous diagnosis or signs of demyelinating diseases
  9. history of uncontrolled diabetes, unstable ischemic heart disease, active inflammatory bowel disease, active peptic ulcer disease, recent stroke, ongoing congestive heart failure, and any other condition which, in the opinion of the investigator, would put the subject at risk by participation in the protocol.
  10. history of cytopenia
  11. laboratory exclusions are: hemoglobin level < 8,5 g/dl, white blood cell count < 3.5 x109/l, platelet count < 125 x 109 /l, creatinine level > 175 µmol/ liver enzymes > 1,5, alkaline phosphatase >2 times the upper limit of normal, Quick > 50.
  12. clinical examination showing significant abnormalities of clinical relevance
  13. participation in trials of other investigational medications within 30 days of entering the study
  14. history or current evidence of abuse of ”hard” drugs (e.g. cocaine/heroine)
  15. current medication with 7,5 mg or more Prednisolon daily
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00244179

Contacts
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

Locations
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         
Sponsors and Collaborators
Charite University, Berlin, Germany
dfg
Investigators
Principal Investigator: joachim sieper, prof. charite, campus benjamin franklin, rheumatology, berlin
  More Information

No publications provided

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

Keywords provided by Charite University, Berlin, Germany:
reactive arthritis
trial
interferon-gamma
infliximab
chronic
tnf-blocker

Additional relevant MeSH terms:
Arthritis, Infectious
Arthritis
Arthritis, Reactive
Joint Diseases
Musculoskeletal Diseases
Infection
Spondylarthropathies
Spondylarthritis
Spondylitis
Spinal Diseases
Bone Diseases
Interferons
Interferon-gamma
Infliximab
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions
Antiviral Agents
Anti-Infective Agents
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-Inflammatory Agents
Antirheumatic Agents
Dermatologic Agents
Gastrointestinal Agents
Central Nervous System Agents

ClinicalTrials.gov processed this record on September 22, 2014