New Immunomodulatory Therapy Strategies in Chronic Reactive Arthritis

NCT00244179 | Unknown Phase 2

• 1 other identifier: ReA01
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief Summary

1. 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. 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. 3.to measure the antigen-specific and -unspecific immune response (predominantly t-cell response) during therapy and correlate it with the clinical course.
4. 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. 5.to compare cytokine-profiles of CD4- and CD8-positive T-cells from patients treated with infliximab to those treated with etanercept.

Conditions

Reactive Arthritis

Keywords

reactive arthritis; trial; interferon-gamma; infliximab; chronic; tnf-blocker

Outcome Measures

Primary Outcomes (2)

• change in intensity of pain (VAS pain, scale 0-10)

• change in funcion (WOMAC)

Secondary Outcomes (10)

• decrease of CRP/ESR

• change of cytokine response

• change of DNA detection

• number of swollen and tender joints

• number of entheseal localisations

Interventions

interferon-gamma DRUG

infliximab DRUG

dmard DRUG

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.
• disease duration \> 12 months
• age 18 to 70 years
• active arthritis in at least one joint
• constant demand of NSAIDs
• intensity of pain \> 4 on a visual analogue scale (VAS; 0 to 10)
• 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
• able to self-administer s.c. injections or have a caregiver who will do so
• 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.
• 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.
• signed informed consent

You may not qualify if:

• female subjects who are pregnant or breast-feeding
• previous treatment with cytokines or anti-cytokines (biological agents)
• severe infections within the last 3 months
• history of opportunistic infections within the last 2 months (herpes zoster, cytomegaly virus-, pneumocystis carinii-infection)
• HIV-infection
• history of malignancy
• receipt of any live (attenuated) vaccines within last 30 days before screening visit
• previous diagnosis or signs of demyelinating diseases
• 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.
• history of cytopenia
• clinical examination showing significant abnormalities of clinical relevance
• participation in trials of other investigational medications within 30 days of entering the study
• history or current evidence of abuse of "hard" drugs (e.g. cocaine/heroine)
• current medication with 7,5 mg or more Prednisolon daily

Sponsors & Collaborators

• Charite University, Berlin, Germany: lead
• dfg: collaborator

Study Sites (1)

Charite Campus Benjamin Franklin, Rheumatology

Berlin, 12200, Germany

RECRUITING

MeSH Terms

Conditions

Arthritis, Reactive; Bronchiolitis Obliterans Syndrome

Interventions

Interferon-gamma; Infliximab; Antirheumatic Agents

Condition Hierarchy (Ancestors)

Arthritis, Infectious; Infections; Spondylarthropathies; Spondylarthritis; Spondylitis; Spinal Diseases; Bone Diseases; Musculoskeletal Diseases; Arthritis; Joint Diseases; Post-Infectious Disorders; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Organizing Pneumonia; Bronchiolitis Obliterans; Bronchiolitis; Bronchitis; Bronchial Diseases; Respiratory Tract Diseases; Lung Diseases, Obstructive; Lung Diseases; Graft vs Host Disease; Immune System Diseases

Intervention Hierarchy (Ancestors)

Interferons; Cytokines; Intercellular Signaling Peptides and Proteins; Peptides; Amino Acids, Peptides, and Proteins; Macrophage-Activating Factors; Lymphokines; Proteins; Biological Factors; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Serum Globulins; Globulins; Therapeutic Uses; Pharmacologic Actions; Chemical Actions and Uses

Study Officials

• joachim sieper, prof.

  charite, campus benjamin franklin, rheumatology, berlin

  PRINCIPAL INVESTIGATOR

Central Study Contacts

joachim sieper, prof.

CONTACT

0049 30 8445; joachim.sieper@charite.de

henning c brandt, md

CONTACT

0049 30 8445; henning.brandt@charite.de

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: ECT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: October 24, 2005
• First Posted: October 26, 2005
• Study Start: January 1, 2003
• Last Updated: September 8, 2006

Record last verified: 2006-09

Locations

DE (1)