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

Helse Stavanger HF28 enrolled

Overview

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.

A double-blind, placebo-controlled, parallel study of the effect on fatigue of daily injections of Anakinra for one month.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

QUADRUPLE

Enrollment

Conditions

Fatigue Primary Sjogren

Interventions

AnakinraDRUG

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

PlaceboDRUG

Saline 0.67 ml daily subcutaneously as placebo drug.

Eligibility

Sex: ALLMin age: 18 YearsMax age: 80 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Primary Sjøgrens Syndrome according to the European-American criteria * Age 18-80 years * Written informed consent Exclusion Criteria: * Hyper- og hypothyreosis * Malignant disease * Parkinsons disease * Multiple sclerosis * Conditions or diseases where Anakinra is contraindicated * Mental depression (BDI \>13) * Neutropenia (\<1.5\*10.9) * Frequent infections * Pregnancy, lactating women.

Locations (1)

Stavanger University Hospital

Stavanger, Norway

Outcomes

Primary Outcomes

Fatigue as measured by Fatigue Severity Scale and a visual analogue fatigue scale

Time frame: 4 weeks

Secondary Outcomes

Inflammatory cytokines and measures of oxidative stress

Time frame: 4 weeks

Data from ClinicalTrials.gov

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