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Interleukin-1 (IL-1) Antagonist

Anakinra 100Mg/0.67Ml Inj Syringe for Endometriosis

Phase < 1

Waitlist Available

Led By Sanjay K Agarwal, MD

Research Sponsored by University of California, San Diego

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be between 18 and 65 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up subjects will complete the baseline questionnaire at visit 1. subjects will fill out monthly questionnaires after the administration of either anakinra or placebo during 6 menstrual periods.

Awards & highlights

Study Summary

This study is evaluating whether a medication which is used to treat rheumatoid arthritis may help reduce pain for women with endometriosis.

Eligible Conditions

Endometriosis
Anakinra
Markers of Inflammation

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ subjects will complete the baseline questionnaire at visit 1. subjects will fill out monthly questionnaires after the administration of either anakinra or placebo during 6 menstrual periods.

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~subjects will complete the baseline questionnaire at visit 1. subjects will fill out monthly questionnaires after the administration of either anakinra or placebo during 6 menstrual periods.

This trial's timeline: 3 weeks for screening, Varies for treatment, and subjects will complete the baseline questionnaire at visit 1. subjects will fill out monthly questionnaires after the administration of either anakinra or placebo during 6 menstrual periods. for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Comparison of the impact of anakinra versus placebo on menstrual pain (dysmenorrhea) using the modified Biberoglu and Behrman scale.

Secondary outcome measures

Comparison of serum inflammatory markers before and after anakinra administration.

Comparison of the impact of anakinra versus placebo on dyspareunia and non menstrual pelvic pain using the modified Biberoglu and Behrman scale.

Comparison of the impact of anakinra versus placebo on the quality of life using the Endometriosis Health Profile 30 questionnaire (EHP-30), conducted after each course of study medication administration.

Side effects data

From 2018 Phase 2 & 3 trial • 104 Patients • NCT01809132

19%

Acute Kidney Injury

11%

Ascites

Nausea

Urinary tract infection

Hematemesis

Upper GI hemorrhage

Clostridium difficile infection

Hepatic failure

Encephalopathy

C. difficile infection

Respiratory Failure

Peritonitis

Esophageal varices hemorrhage

Tachycardia

Multiple Organ Dysfunction Syndrome (MODS)

Viremia

Baceteremia

100%

80%

60%

40%

20%

Study treatment Arm

Anakinra & Pentoxifylline & Zinc Sulfate

Methylprednisolone

Observational

Trial Design

2Treatment groups

Experimental Treatment

Placebo Group

Group I: Active Treatment with AnakinraExperimental Treatment1 Intervention

10 subjects will be enrolled in this group. Initial treatment will consist of 100mg/day Anakinra, which is the standard, FDA approved dose for the treatment of rheumatoid arthritis. The randomized treatment will be self-administered by the subject each evening by subcutaneous injection from within 24 hours of the onset of menses until within 24 hours of last menstrual day.

Group II: Standard ComparisonPlacebo Group1 Intervention

10 subjects will be enrolled in this group. This group will be given placebo injections as their initial treatment. The placebo is comparable to the anakinra formulation without the active medication - a solution (pH 6.5) containing anhydrous citric acid (1.29 mg), disodium EDTA (0.12 mg), polysorbate 80 (0.70 mg), and sodium chloride (5.48 mg) in water for injection. These individuals will self-administer the placebo each evening by subcutaneous injection from within 24 hours of the onset of menses until within 24 hours of last menstrual day.

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