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Fatigue and Interleukin-1 (IL-1) Blockade in Primary Sjøgrens Syndrome

NCT00683345 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 28

Last updated 2015-08-19

No results posted yet for this study

Summary

Fatigue is a prevalent phenomenon in Primary Sjøgrens syndrome (PSS). Observations indicate that the cytokine IL-1 is of importance for this phenomenon. In this study the investigators block IL-1 by giving Anakinra (an IL-1 receptor antagonist) to patients with PSS.

Conditions

Interventions

DRUG

Anakinra

Anakinra 0.67 ml (100 mg) daily subcutaneously for 4 weeks.

DRUG

Placebo

Saline 0.67 ml daily subcutaneously as placebo drug.

Sponsors & Collaborators

  • University of Oslo

    collaborator OTHER

  • University of Stavanger

    collaborator OTHER

  • Helse Stavanger HF

    lead OTHER_GOV

Principal Investigators

  • Roald Omdal, PhD · Helse Stavanger HF

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2008-01-31
Primary Completion
2010-04-30
Completion
2010-04-30

Countries

  • Norway

Study Locations

More Related Trials

Entities

Drugs
Diseases

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 NCT00683345 on ClinicalTrials.gov