Recruiting
Early Phase 1

Anakinra

Sponsor:

UCLA

Code:

NCT03991520

Conditions

Endometriosis

Anakinra

Markers of Inflammation

Eligibility Criteria

Sex: Female

Age: 18 - 45

Healthy Volunteers: Not accepted

Interventions

Anakinra 100Mg/0.67Ml Inj Syringe

Placebo

Study Details

Brief summary:

All current FDA approved medications to treat endometriosis pain including danazol, GnRH agonists (Lupron, Zoladex and Synarel), GnRH antagonist (elagolix) and depo-provera prevent or contradict pregnancy. Therefore women suffering from endometriosis and trying to conceive have no medical options apart from pain meds. The purpose of this pilot study is to determine whether the anti-inflammatory, IL-1 inhibitor (anakinra) reduces pelvic pain due to endometriosis without altering menstrual cycles, which is an indicator of ovulatory function. Anakinra is an FDA approved injectable medication for the treatment of rheumatoid arthritis that is pregnancy category B.

Conditions

Endometriosis

Anakinra

Markers of Inflammation

Study ID

NCT03991520

Start date

Jun 16, 2020

Status verified date

May, 2021

Completion date

Jan, 2022

Anticipated

Primary completion date

Jan, 2022

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: Female

Age: 18 - 45

Healthy Volunteers: Not accepted

Inclusion Criteria:

  • Women aged 18-45 with regular menstrual periods every 24-32 days and not lasting more than 10 days per month
  • Surgical or imaging proven endometriosis.
  • At least a moderate level of menstrual pain based on the patient reported parameters of the B\&B pain scale (>4/9) with dysmenorrhea being scored at least 2/3.
  • Willing to remain on your current method of hormone therapy for duration of study

Exclusion Criteria:

  • History of hysterectomy or oophorectomy.
  • Non-response to GnRH agonist/antagonist, DMPA, aromatase inhibitors or danazol.
  • Currently pregnant or attempting pregnancy.
  • Contraindication to anakinra.
  • Chronic kidney disease stage 4 and 5 or creatinine clearance <30mL/min/1.73m2.
  • Abnormal LFTs, CBC or serum electrolytes including estimated GFR.
  • Patient refusal.
  • Plan to receive a live vaccine

Study Design

Enrollment

20 participants

Anticipated

Allocation

Randomized

Intervention Model

Crossover

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Active Treatment with Anakinra

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.

placebo comparator: Standard Comparison

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.

Interventions

Anakinra 100Mg/0.67Ml Inj Syringe

The study drug is100mg/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.

Placebo

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

Primary outcome measure

  • Comparison of the impact of anakinra versus placebo on menstrual pain (dysmenorrhea) using the modified Biberoglu and Behrman scale. [ Time Frame: 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. ]

Central Contacts and Locations

Central contacts

Celestine Magallanes, BS

8582495419cgmagall@health.ucsd.edu

Locations

UCSD Reproductive Endocrinology

Recruiting

La Jolla, California, United States, 92037

Contacts

Celestine Magallanes, BS

858-249-5419cgmagall@health.ucsd.edu

More Information

Sponsor

University of California, San Diego

Last update posted

May 28, 2021

Last verified

May, 2021

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by University of California, San Diego on 2021-05-28.