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Identification of Novel Molecular Targets for Rheumatoid Arthritis Patients

NCT04201535 · Status: UNKNOWN · Type: OBSERVATIONAL · Enrollment: 160

Last updated 2019-12-17

No results posted yet for this study

Summary

Aims of this study is to identify the mechanisms of the dissociation between the inflammatory activity and the joints destruction in patients with rheumatoid arthritis (RA) in remission but presenting a progression of the bone erosions.

160 total patients will be enrolled. Males and females RA patients in clinical remission or not, osteoarthritis patients and patients hospitalized for any other orthopedics pathology (used as controls) will be enrolled. From RA patients with bone erosion, OA patients and controls whole blood will be collected; from RA patients without bone erosion whole blood will be collected. From whole blood mononuclear cells will be isolated and plasma will be harvested. From both RA and OA patients synovial fluid will be collected along with mononuclear cells present in this fluid and from both RA and OA patients candidate for total articular replacement fragments of synovial membrane, cartilage, bone and bone marrow will be collected during surgery as waste material.

The nuclear cells isolated from whole blood, synovial fluid and bone marrow will be characterized using a panel of markers. Protein arrays on plasma samples obtained from RA, OA patients and controls will be performed to identify a panel of acute phase proteins, cytokines and chemokines present at systemic levels and to highlight analogies and differences in the systemic protein profile.

The synovial fluid will be used to identify the proteins present in the synovial fluid of RA and OA patients. The main identified target will be quantified and used as markers of erosion progression, to develop intra-articular pharmacological therapies and to suggest the therapeutic doses of drugs. The same kind of analysis will be performed even on tissues obtained from surgical patients (RA and OA patients) to establish the pathways involved and the tissue specific targets to be stimulated, i.e. with trophic factors, to promote the tissue homeostasis after switching-off the autoimmune and inflammatory processes.

Conditions

  • Arthritis, Rheumatoid
  • Bone Erosion

Interventions

DIAGNOSTIC_TEST

Protein arrays on plasma samples

Protein arrays on plasma samples obtained from RA, OA patients and controls will be performed to identify a panel of acute phase proteins, cytokines and chemokines present at systemic levels and to highlight analogies and differences in the systemic protein profile.The synovial fluid will be used to identify through high-throughput MudPIT the proteins present in the synovial fluid of RA and OA patients.

Sponsors & Collaborators

  • I.R.C.C.S Ospedale Galeazzi-Sant'Ambrogio

    lead OTHER

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2017-12-21
Primary Completion
2020-09-30
Completion
2021-06-30

Countries

  • Italy

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04201535 on ClinicalTrials.gov