Not Authorised Therapeutic exploratory (Phase II) Osteoarthritis

Research into existing medicines to reduce aging, pain, and inflammation in osteoarthritis.

EU CTIS ID: 2025-524885-12-00

What this study is testing

The main objective of this trial is to evaluate the potential of existing 2-drug combinations on slowing epigenetic and biological age acceleration in patients with knee osteoarthritis (OA).

  • Therapeutic exploratory (Phase II)

A plain-language read of the study's public EU CTIS listing. The study team confirms the details.

Who can take part

You may be able to join if

  • Written informed consent
  • Age ≥18 and <80
  • Radiological diagnosis of knee osteoarthritis according to their general practitioner and/or medical specialist (e.g. orthopaedic surgeon, rheumatologist), with a KL grade ≥ 2.
  • Ability to swallow and retain oral medication

You likely can't join if

  • Known allergy or hypersensitivity to any of the medications or their excipients in the clinical trial (baricitinib, dolutegravir, metformin, colchicine)
  • Received vaccination within two weeks before the start of the study.
  • Peripheral neuritis, myositis or marked myo-sensitivity to statins.
  • Male participants not willing to use effective contraception during the study to prevent pregnancy
  • Using medications that are substrates of OCT2, inhibitors of OCT1, inducers of OCT1, inhibi-tors of OCT2, inducers of OCT2, strong CYP3A4 inhibitors, strong CYP3A4 inducers, , strong OAT3 inhibitors, substrates of Pgp, and/or substrates of BCRP. A non-exhaustive list of such medications is given below; fampridine (or dalfampridine); macrolide antibiotics (i.e. eryth-romycin, azithromycin); probenecid ;antimycotics (i.e. ketoconazole, fluconazole, itracona-zole, posaconazole and voriconazole); antimycobacterials (rifabutin, rifampicin); anticon-vulsants (carbamazepine, oxcarbazepine, phenytoin, phenobarbital); protease inhibitors & anti-retroviral drugs (i.e. boceprevir, nelfinavir ritonavir, lopinavir, tipranavir, atazanavir, darunavir, indinavir, saquinavir, and cobicistat); anti-arrhythmic drugs (i.e. verapamil, dilti-azem); immunosuppressants (i.e. cyclosporine); hepatitis C drug telaprevir; atypical antide-pressant nefazodone and herbal product St. John’s wort.
  • Other known medical diseases that may affect joints.
See the full eligibility criteria
Who can join
  • Written informed consent
  • Age ≥18 and <80
  • Radiological diagnosis of knee osteoarthritis according to their general practitioner and/or medical specialist (e.g. orthopaedic surgeon, rheumatologist), with a KL grade ≥ 2.
  • Ability to swallow and retain oral medication
What rules you out
  • Known allergy or hypersensitivity to any of the medications or their excipients in the clinical trial (baricitinib, dolutegravir, metformin, colchicine)
  • Received vaccination within two weeks before the start of the study.
  • Peripheral neuritis, myositis or marked myo-sensitivity to statins.
  • Male participants not willing to use effective contraception during the study to prevent pregnancy
  • Using medications that are substrates of OCT2, inhibitors of OCT1, inducers of OCT1, inhibi-tors of OCT2, inducers of OCT2, strong CYP3A4 inhibitors, strong CYP3A4 inducers, , strong OAT3 inhibitors, substrates of Pgp, and/or substrates of BCRP. A non-exhaustive list of such medications is given below; fampridine (or dalfampridine); macrolide antibiotics (i.e. eryth-romycin, azithromycin); probenecid ;antimycotics (i.e. ketoconazole, fluconazole, itracona-zole, posaconazole and voriconazole); antimycobacterials (rifabutin, rifampicin); anticon-vulsants (carbamazepine, oxcarbazepine, phenytoin, phenobarbital); protease inhibitors & anti-retroviral drugs (i.e. boceprevir, nelfinavir ritonavir, lopinavir, tipranavir, atazanavir, darunavir, indinavir, saquinavir, and cobicistat); anti-arrhythmic drugs (i.e. verapamil, dilti-azem); immunosuppressants (i.e. cyclosporine); hepatitis C drug telaprevir; atypical antide-pressant nefazodone and herbal product St. John’s wort.
  • Other known medical diseases that may affect joints.
  • Known generalized pain syndromes such as fibromyalgia.
  • High frailty (Clinical Frailty Scale ≥ 7) or predicted life expectancy < 5 years.
  • Current enrollment in another trial.
  • Incapacitated patients.
  • Pregnant or breastfeeding females.
  • A planned surgery under general, spinal, or epidural anesthesia.
  • Fertile female participants not taking sufficient contraception.
  • Having had a diagnosis of depression.
  • Immunodeficiencies and autoimmune diseases.
  • Acute and unstable heart failure.
  • Alcohol addiction (i.e. >14 units per week).
  • Current or past long-time smokers (i.e. one or more cigarettes per day).
  • Having had hepatitis B or tuberculosis.
  • Having had cancer.
  • A planned imaging procedure involving the intravascular administration of iodinated contrast agents
  • Having had Herpes zoster.
  • Any type of acute metabolic acidosis (lactic acidosis, diabetic ketoacidosis).
  • Having had venous thromboembolism.
  • Current use of one or more of the study medications for any indication (baricitinib, dolutegravir, metformin, colchicine).
  • Moderate or severe renal impairment (eGFR<50mL/min/1.73m2)
  • Liver function impairment as evidenced by serum alanine transferase (ALAT) > 3 ULN (up-per limit of normal).
  • Abnormal lymphocyte or neutrophil counts or haemoglobin levels (Lymphocyte counts <0.5 * 10^9/ul, or neutrophil counts < 1 * 10^9/µL or haemoglobin <8 mmol/L for men and <7 mmol/L for women).
  • Use of systemic immunomodulatory drugs: steroids, anti-inflammatory biological treatments (e.g., anti-cytokine monoclonal antibodies).
  • Acute or active illness within two weeks before the start of the study.

The study team makes the final eligibility decision.

Questions & answers

Do participants get paid in this trial?

This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.

Is it free to join, and do I need insurance?

Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.

How long does this study last?

The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.

Who can join this trial?

This study is enrolling all sexes, 65+ years, 18-64 years. The study team makes the final eligibility decision.

Explore other conditions

BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.