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

Helse Stavanger HF

Status and phase: Completed; Phase 2

Conditions: Primary Sjogren; Fatigue

Treatments: Drug: Placebo; Drug: Anakinra

Study type: Interventional

Funder types: Other

Identifiers

NCT00683345

2007-000475-41 (EudraCT Number)

P REK NORD 60/2007

17772 (Other Identifier)

07/03834-7 (Other Identifier)

Details and patient eligibility

About

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.

Full description

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

Enrollment: 28 patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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28 participants in 2 patient groups, including a placebo group

Anakinra

Active Comparator group

Description:

Anakinra self-administered s.c. in a dose of 100mg daily

Treatment:

Drug: Anakinra

Placebo

Placebo Comparator group

Description:

Placebo self-adminsitered s.c in a dose 0.67ml daily

Treatment:

Drug: Placebo