Efficacy of Ixekizumab Versus Methotrexate in Psoriatic Arthritis Dactylitis: A Multicenter, Randomized Controlled Trial
- Trial ID
- 2022-503119-40-00
- Protocol
- DACTOS
Trial statistics
Diseases & Conditions
Objectives
The primary objective of this study is to assess the **efficacy** of **ixekizumab** monotherapy compared to **methotrexate** monotherapy in the treatment of **psoriatic arthritis** (PsA) dactylitis. This evaluation is clinically relevant as it aims to determine the most effective treatment option for managing dactylitis, a common and debilitating manifestation of PsA, thereby potentially improving patient outcomes and quality of life. Additionally, the study seeks to evaluate the degree of response using the DACTOS score, which provides a standardized measure of treatment effectiveness in this condition.
Participants
The clinical trial involves participants diagnosed with **psoriatic arthritis (PsA)**, specifically focusing on those with active dactylitis. The study population includes both male and female adults aged 18 years and older. Participants are required to meet the CASPAR criteria for PsA and must be naïve to csDMARDs and/or bDMARDs. The trial does not include a vulnerable population. The sponsor has not provided information regarding the total number of participants. Selection criteria emphasize the presence of active dactylitis, which is diagnosed and evaluated through physical examination at each center. Lifestyle considerations such as diet, physical activity, or habits are not specified in the available data.
Plans and Procedures
The clinical trial is designed to evaluate the **efficacy** of **ixekizumab** monotherapy compared to **methotrexate** monotherapy in patients with **psoriatic arthritis** (PsA) dactylitis. This study is a multicentre, parallel-groups, randomized controlled trial. The trial will commence with a screening visit to confirm eligibility based on the CASPAR criteria for PsA, ensuring participants are adults aged 18 years or older, naïve to csDMARDs and/or bDMARDs, and have active dactylitis. The trial is expected to start recruitment on December 1, 2025, and conclude by December 1, 2027, with a maximum treatment period of six months for ixekizumab and one month for methotrexate.
Participants will be randomly assigned to receive either ixekizumab or methotrexate, both administered subcutaneously. The primary endpoint is to assess the therapeutic response using the DACTOS score and sonographic evaluation of dactylitis lesions. Study visits will include baseline assessments, regular follow-up visits to monitor treatment response and safety, and an end-of-study visit to evaluate the overall efficacy and safety of the interventions. The expected length of participant involvement is up to six months, depending on the assigned treatment group.
Conditions that may lead to early termination from the study include adverse events, withdrawal of consent, or any protocol violations that compromise the integrity of the trial. The trial is not classified as low intervention and is conducted under Phase III, ensuring rigorous evaluation of the therapeutic interventions. The study aims to provide valuable insights into the management of PsA dactylitis, contributing to the optimization of treatment strategies for this condition.
Treatment
The clinical trial involves the administration of **Taltz**, which contains the active substance **ixekizumab**. This medication is provided as a **solution for injection in a pre-filled syringe**. Each syringe contains 80 mg of ixekizumab. The pharmaceutical form is a solution for injection, and the route of administration is **subcutaneous**. The maximum daily dose is 160 mg, with a total maximum dose of 160 mg over a treatment period of up to 6 months. The medication is manufactured by Eli Lilly and Company (Ireland) Limited. Participant compliance with the dosing schedule will be monitored throughout the trial.
The comparator treatment in this study is **Metother**, which contains the active substance **methotrexate**. This medication is also provided as a **solution for injection in a pre-filled syringe**, with a concentration of 50 mg/ml. The pharmaceutical form is a solution for injection, and the route of administration is **subcutaneous**. The maximum daily dose is 7 mg, with a total maximum dose of 25 mg over a treatment period of up to 1 month. The medication is manufactured by Accord Healthcare S.L.U. Compliance with the dosing schedule will be monitored to ensure adherence to the treatment protocol.
Efficacy
The efficacy of ixekizumab monotherapy versus methotrexate monotherapy in the treatment of **psoriatic arthritis (PsA) dactylitis** will be assessed in this clinical trial. The primary endpoints include evaluating the degree of response using the DACTOS score and monitoring changes in sonographically detected elementary lesions of dactylitis in PsA participants. Efficacy will be measured through clinical and ultrasound assessments, focusing on the therapeutic response to ixekizumab. The trial is designed as a multicentre, parallel-groups, randomized controlled trial.
Inclusion and Exclusion Criteria
Inclusion Criteria
- adult age (≥ 18 years); - fulfilment of CASPAR criteria for PsA [2]; - naïve to csDMARDs and/or bDMARDs;; - presence of active dactylitis, diagnosed and evaluated at each centre through physical examination
Exclusion Criteria
- -participation in another concurrent clinical intervention study within 30 days of randomization; - planned administration of live vaccines during the study period; - previous treatment with lymphocyte-depleting therapies or alkylating agents; - presence of one or more contraindication reported in datasheets of administered study drugs; - haemoglobin<9.0 g/dL, white-cell count<3.0×109/L, absolute neutrophil count<1.2×109/L, platelet count<100×109/L; - estimated glomerular filtration rate<40 ml/min (method of Cockcroft and Gault); - aspartate aminotransferase and/or alanine aminotransferase >1.5 times the upper normal range; - another autoimmune rheumatic disease except Sjogren’s syndrome; - recent, current, or chronic infection, including hepatitis B or hepatitis C infection or human immunodeficiency virus infection; - evidence of active, latent, or inadequately-treated Mycobacterium Tuberculosis infection; - a history of lymphoproliferative disorder; - major surgery within two weeks before starting study drugs, or having unhealed operation wounds; - history of cancer, except adequately treated, non-metastatic basal-cell or squamous-cell cancer of the skin or cervical carcinoma in situ; - Pregnant or lactating women (women of childbearing potential should have a negative test for HCG); - significant history of alcohol/drug abuse or addiction; - foreseeable inability to cooperate with given instructions and study procedures; - any condition precluding the administration of study drugs in compliance with datasheets indications; - any condition or laboratory parameter precluding the inclusion of the participant according to investigator.
Trial Status by Country
| Country | Status | Start of Recruitment | Planned Patients |
|---|---|---|---|
 Italy | Not Yet Recruiting | 01 Dec 2025 | 60 |
Sites & Investigators
Investigational Products
Details about the medicinal products being studied in this clinical trial.
| Product Name | Role in Trial | Formulation | Administration | Max Daily Dose | Treatment Duration | EU MP Number |
|---|---|---|---|---|---|---|
Taltz 80 mg solution for injection in pre-filled syringe | Test | SOLUTION FOR INJECTION IN PRE-FILLED SYRINGE | SUBCUTANEOUS | 160 | 6 | PRD3995196 |
Metother 50 mg/ml soluzione iniettabile in siringa pre-riempita. | Comparator | SOLUZIONE INIETTABILE IN SIRINGA PRE-RIEMPITA | SUBCUTANEOUS | 7 | 1 | PRD4468465 |