Trial document





This trial has been registered retrospectively.
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  DRKS00006057

Trial Description

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Title

Evidence and functions of surfactant-associated proteins and trefoil factor family (TFF) peptides in the synovial fluid, synovial membrane and cartilage tissue in children and adolescents with inflammatory joint diseases

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Trial Acronym

TFF-Surfactant-JIA-2013

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URL of the Trial

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Brief Summary in Lay Language

At the current time, nothing is known about the role of TFF proteins and surfactant proteins, as part of inherent, evolutionary biological older immunity, in the joints of children and adolescents, or in chronic inflammatory joint diseases. Likewise, it is not known whether these proteins play a role in the pathogenesis of JIA, in particular in cases involving rapid joint deterioration.
A complete picture of the existence and possible function of the recently identified SP-G and -H in joints is not available. Some data exists concerning the related but not identical disease rheumatoid arthritis (RA) with respect to SP-A and -D.
The problem outlined shall be the object of our fundamental scientific investigation and shall help to close a knowledge gap.

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Brief Summary in Scientific Language

At the current time, nothing is known about the role of TFF proteins and surfactant proteins, as part of inherent, evolutionary biological older immunity, in the joints of children and adolescents, or in chronic inflammatory joint diseases. Likewise, it is not known whether these proteins play a role in the pathogenesis of JIA, in particular in cases involving rapid joint deterioration.
A complete picture of the existence and possible function of the recently identified SP-G and -H in joints is not available. Some data exists concerning the related but not identical disease rheumatoid arthritis (RA) with respect to SP-A and -D.
The problem outlined shall be the object of our fundamental scientific investigation and shall help to close a knowledge gap.

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Organizational Data

  •   DRKS00006057
  •   2014/07/04
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  •   yes
  •   Approved
  •   2013-30, Ethikkommission der Medizinischen Fakultät der Martin-Luther-Universität Halle Wittenberg
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Secondary IDs

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Health Condition or Problem studied

  •   -Patients with any subtype of a JIA
    -Patients with infectious arthritis (Lyme arthritis)
    -Patients with septic arthritis
    -Patients with surgical synovectomy (JIA)
    -Non-infectious, deceased premature babies and newborns or deceased children and adolescents (autopsy material)
  •   M08 -  Juvenile arthritis
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Interventions/Observational Groups

  •   1. Suitable patients will be included once the detailed explanation has been given and the relevant informed consents have been signed.
    2. The clinical record and documentation of the characteristics of the disease and the required patient data are pseudonymised in standardised CRF forms.
    3. Record the activity parameters in the JIA group, amongst others.
    4. In the event that samples of any kind are taken (from the living body or the corpse) due to a medical indication, or as a result of the clinical or court-ordered post mortem examination, a section will be stored, partly frozen, in a defined medium at the Erlangen – Nuremberg Anatomy Department in accordance with the regulations of the study protocol, after notification has been sent (blood, synovial membrane, synovial fluid, cartilage).
    5. At this location, the sample preparations will be produced and prepared using: H&E stains, connective tissue stains, immunohistochemistry in paraffin sections, Western blot analysis, ELISA and immunogold transmission electron microscopy (iTEM).
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Characteristics

  •   Non-interventional
  •   Observational study
  •   Other
  •   Open (masking not used)
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  •   Other
  •   Basic research/physiological study
  •   Other
  •   N/A
  •   N/A
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Primary Outcome

1. Qualitative and quantitative determination of surface-active substances in the case of JIA in comparison to “healthy” joints and other joint diseases (SP-A to -H)
2. Qualitative and quantitative determination of trefoil factor family peptides TFF 1-3 in various joint diseases
3. Correlation of the evidence of the above-named substances with the age, tissue type or compartment (cartilage, synovial membrane, synovial fluid, blood) as well as the type of joint disease and disease activity

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Secondary Outcome

1. Deeper understanding and generation of new knowledge with respect to the pathomechanism of joint diseases in children, in particular also the role inherent immunity plays in this
2. Identify possible new targets for anti-rheumatic treatment

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Countries of Recruitment

  •   Germany
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Locations of Recruitment

  • Medical Center 
  • Medical Center 
  • other 
  • Medical Center 
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Recruitment

  •   Actual
  •   2014/03/01
  •   135
  •   Multicenter trial
  •   National
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Inclusion Criteria

  •   Both, male and female
  •   1   Days
  •   16   Years
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Additional Inclusion Criteria

Gender: Both, male and female
Minimum age: 1 day
Maximum age: 16 years

Additional Inclusion Criteria
1. Confirmed JIA (according to ILAR 1997)
2. Age ≥ 1 day up to ≤ 16 years for patients with JIA and joint infections
3. Age for autopsy cases (non-JIA): premature babies up to 16 years of age
4. In the case of JIA and “non-synovectomy cases”: New manifestation of JIA and/or prior to use of immunomodulation (corticoids, MTX, other basic medications, biologicals)
5. Collection of a blood sample, puncture of the joint, arthroscopic synovectomies, open synovectomies or chondrectomies for a medical indication (e.g. JIA or joint infection)
6. Infections of joints before antibiotic treatment
7. Authorised autopsies for deceased children and adolescents

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Exclusion Criteria

1. Patients with JIA that belong to none or 2 subtypes of JIA
2. Any infection in the autopsy group
3. Any infection in the JIA group
4. Any infection in the synovectomy group
5. Lack of medical indication to collect blood samples, arthrocenteses, synovectomies, chondrectomies or procedures on the joint in general
6. Patients who have already commenced immunosuppression or immunomodulation in the JIA group (non-synovectomies)
7. Procedures on the jaw joint
8. Suspected shaken baby syndrome in the autopsy groups
9. Lack of written consent forms of the parents and/or patients to any medically indicated joint procedures or to collect blood samples
10. Lack of written informed consent forms of the parents/guardians in the cases of clinical post mortem examinations (autopsy cases)
11. Lack of written consent of the public prosecution office in exceptional cases involving court-ordered post mortem examinations

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Addresses

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    • Dekanat der MLU Halle-Wittenberg
    • Mr.  Dekan der Medizinischen Fakultät Prof. Dr.  Michael  Gekle 
    • Magdeburger Straße 8
    • 06112  Halle
    • Germany
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    • Insitut für Anatomie (Lehrstuhl II)Friedrich-Alexander-Universität Erlangen-Nürnberg
    • Mr.  Prof. Dr.  Friedrich  Paulsen 
    • Universitätsstraße 19
    • 91054  Erlangen
    • Germany
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    • Universitätsklinik und Poliklinik für Kinder- und Jugendmedizin Halle
    • Mr.  Dr. med.  Thomas  Müller 
    • Ernst-Grube-Straße 40
    • 06120  Halle (Saale)
    • Germany
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    • Universitätsklinik und Poliklinik für Kinder- und Jugendmedizin Halle
    • Mr.  Dr. med.  Thomas  Müller 
    • Ernst-Grube-Straße 40
    • 06120  Halle (Saale)
    • Germany
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Sources of Monetary or Material Support

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    • Martin-Luther-Universität Halle
    • 06097  Halle
    • Germany
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Status

  •   Recruiting ongoing
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Trial Publications, Results and other Documents

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