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Study on Baricitinib for Patients with Calcium Pyrophosphate Deposition Disease (CPPD) Using Methotrexate Sodium and Drug Combination

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What is this trial about?

A plain-language summary of the goals, design and what participants do

This clinical trial is focused on studying the effects of the medication Baricitinib on a condition known as Calcium Pyrophosphate Deposition Disease (CPPD). CPPD is a type of arthritis that causes joint pain and swelling due to the buildup of calcium crystals in the joints. The purpose of the study is to evaluate how Baricitinib affects inflammation in the joint lining, which is a common issue in people with CPPD.

Participants in the study will receive Baricitinib in the form of film-coated tablets. The study will also involve other medications, including Methotrexate Sodium, Colchicine, Tiemonium Methylsulphate, Calcium Folinate, Hydroxychloroquine Sulfate, and Lidocaine Hydrochloride Monohydrate. These medications are used for various purposes, such as reducing inflammation, managing pain, and supporting joint health. Some participants may receive a placebo, which is a substance with no active medication, to compare the effects of the treatments.

The study will last for a period of 24 weeks, during which participants will take the medication orally. Throughout the study, changes in joint inflammation and other health indicators will be monitored. The goal is to understand how Baricitinib and the other medications can help manage symptoms of CPPD and improve the quality of life for those affected by this condition.

The research process

The trial runs in 6 steps – from screening to follow-up. Each step says what happens and what the team monitors.

Step 1
Enrollment
Upon joining the study, the patient will be required to provide a signed informed consent.
Eligibility criteria include being 55 years or older and meeting specific medical conditions related to calcium pyrophosphate deposition disease (CPPD).
Step 2
Initial Assessment
An initial assessment will be conducted to evaluate the patient's condition and suitability for the trial.
This may include a synovial biopsy at the knee or wrist joint to confirm the presence of CPPD.
Step 3
Medication Administration
The patient will begin taking Baricitinib, administered orally in the form of Olumiant 4 mg film-coated tablets.
The medication is intended to evaluate its effect on inflammation of the synovial membrane in CPPD.
Step 4
Monitoring and Follow-up
The patient's response to the medication will be monitored over a period of 12 weeks.
Primary outcomes will be assessed through changes in synovial tissue CD68 scoring.
Step 5
Secondary Assessments
Secondary outcomes will be evaluated at 4, 12, and 24 weeks, including changes in synovitis scores, pain levels, and serum cytokine levels.
These assessments will help determine the overall effectiveness and safety of the treatment.
Step 6
Completion
The trial is expected to conclude by October 15, 2026.
Final assessments will be conducted to gather comprehensive data on the treatment's impact.

Who can join the trial?

13 criteria

Must have signed an agreement to participate, known as a Signed Informed Consent.
Must be a male or female aged 55 years or older.
For women, must be in menopause, which means no menstrual periods for 12 months without another medical reason. A high level of a hormone called follicle stimulating hormone can confirm menopause if not using hormone treatments.
Male participants must avoid fathering a child during the study. They must use effective birth control methods or have a partner who is in menopause. Acceptable methods include:
- Total abstinence, meaning no sexual activity, if it is a usual lifestyle choice.
- Female partner sterilization, such as surgical removal of ovaries or uterus, or having tubes tied.
- Male sterilization, like a vasectomy, done at least 6 months before joining the study.
- Barrier methods like condoms or caps.
- Female partner using hormonal birth control methods like pills, injections, implants, or devices placed inside the uterus.
- Must meet the 2023 ACR/EULAR classification criteria for calcium pyrophosphate deposition disease (CPPD).
- Must be able to have a synovial biopsy, which is a small tissue sample taken from the knee or wrist joint.
- Must have a specific type of CPPD:
  - Subset 1: Involves small joints and tendons in hands and wrists, similar to rheumatoid arthritis. Includes joint swelling or inflammation in certain hand joints or tendons.
  - Subset 2: Involves large joints with repeated swelling or inflammation not improved by a single steroid injection. Includes frequent attacks in one joint over the past year.
  - Must be considered by the study doctor to benefit from the treatment, meaning a favorable benefit/risk profile.

Who cannot join the trial?

7 criteria

Patients who are pregnant or breastfeeding cannot participate.
Individuals with a history of severe allergic reactions to the study medication are excluded.
Patients with other serious health conditions that might interfere with the study are not eligible.
Participants who are currently taking medications that could affect the study results are not allowed.
Individuals who have participated in another clinical trial within the last 30 days are excluded.
Patients with a history of drug or alcohol abuse in the past year cannot join the study.
Anyone who is unable to comply with the study procedures or follow-up visits is not eligible.

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Ospedale Galeazzi S.p.A.
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Milan, Italy

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Investigated drugs

Baricitinib is a medication being studied for its potential to reduce inflammation in the synovial membrane, which is a common issue in calcium pyrophosphate dihydrate deposition disease (CPPD). The trial aims to see how effective Baricitinib is in changing the inflammation levels in the joint tissue over a period of 12 weeks.

What is already known about the treatment

Baricitinib – Baricitinib is administered orally in tablet form. It is currently being studied in clinical trials for its potential use in treating calcium pyrophosphate deposition disease (CPPD). The main therapeutic indication for Baricitinib in this context is to reduce inflammation of the synovial membrane associated with CPPD. At the molecular level, Baricitinib works by inhibiting Janus kinase (JAK) enzymes, which play a role in the inflammatory process. It is classified pharmacologically as a JAK inhibitor.

Investigated diseases

Calcium Pyrophosphate Deposition Disease – This condition is characterized by the accumulation of calcium pyrophosphate crystals in the joints, leading to inflammation and pain. It often affects the knees, wrists, and other large joints, causing symptoms similar to gout. The disease can progress with episodes of acute joint pain and swelling, known as pseudogout, or it can present as a chronic arthritis with persistent joint discomfort. Over time, the repeated inflammation can lead to joint damage and reduced mobility. The exact cause of the crystal formation is not fully understood, but it is associated with aging and certain metabolic conditions. The disease is diagnosed based on clinical symptoms and the presence of crystals in joint fluid.