The effects of belimumab on synovial inflammation and composition of lymph nodes in SLE patients

Recruitment & Eligibility

Status: Pending

Sex: Not specified

Target Recruitment: 15

Inclusion Criteria

SLE patients who:
1. fulfill ACR 1997 and/or SLICC and/or ACR/ EULAR 2019 criteria,
2. have active joint disease (arthritis) in wrist, knee or ankle joints.
3. have a SLEDAI-2K score >=6.
4. are aged between 18-75
5. start with belimumab

Exclusion Criteria

Patients who are not able to give informed consent.
Pregnancy
Severe renal impairment (eGFR <30ml/min/1.73m2)
Active nephritis
Present or previous treatment with any cell depleting therapies, including
anti-B-cell therapy or other investigational agents
Intravenous cyclophosphamide 90 days prior to belimumab
Any non-biologic investigational agent 30 Days Prior to belimumab (or 5
half-lives, whichever is greater)
Live vaccines within 30 days prior to baseline or concurrently with belimumab
Presence of any other disease for which study subjects need chronic or
intermittent immunosuppressive therapy (e.g. prednisolon for COPD).
History of malignancies neoplasm within the last 5 years except basal cell or
squamous cell carcinoma of the skin treated with local resection only or
carcinoma in situ of the uterine cervix treated locally and with no evidence of
metastatic disease for 3 years
Have any intercurrent significant medical or psychiatric illness that the
investigator considers would make the candidate unsuitable for the study,
including evidence of serious suicide risk including any history of suicidal
behaviour in the last 6 months and/or any suicidal ideation in the last 2
months or who in the investigator's judgment, poses a significant suicide risk
Have current drug or alcohol abuse or dependence, or a history of drug or
alcohol abuse or dependence within 365 days prior to Day 0
Have a historically positive HIV test or test positive at screening for HIV, or
other immunodeficiency

Study & Design

Study Type: Observational invasive

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>Differences in lymph node cellular composition and functional aspects in SLE<br /><br>patients starting with belimumab compared to SLE patients starting any other<br /><br>effective treatment.</p><br>

Secondary Outcome Measures

Name	Time	Method
<p>Differences in peripheral blood cellular composition and functional aspects in<br /><br>SLE patients starting with belimumab compared to SLE patients starting any<br /><br>other effective treatment.</p><br>