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Testing the safety and efficacy of combining biologic drugs in Rheumatoid and Psoriatic Arthritis
EU CTIS ID: 2024-518011-19-01
What this study is testing
Proportion of patients who achieve disease remission at week 24 will be the primary endpoint. Remission will be defined by: Clinical Disease Activity Index (CDAI) 2.8 or < 2.8 in RA DAPSA <4 in PsA
- 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
- Adult patients (≥18 years old), no upper age limit;
- Patient must fulfil either European Alliance of Associations for Rheumatology (EULAR)/Albumin: Creatinine Ratio (ACR) classification criteria for the diagnosis of Rheumatoid Arthritis, or Classification Criteria of Psoriatic Arthritis (CASPAR);
- Current treatment with any approved Tumour Necrosis Factor inhibitors (TNFis) for at least 6 weeks
- Active arthritis as defined by: • DAS28 score > 3.2 for Rheumatoid Arthritis • Disease Activity in Psoriatic Arthritis (DAPSA) >14 for Psoriatic Arthritis
- Signed informed consent
You likely can't join if
- Contraindications to any of the biologic treatment e.g. active infection;
- Sepsis of a prosthetic joint within 12 months or indefinitely if the joint remains in situ
- Known HIV or hepatitis B/C infection (satisfactory hepatitis B screening test must have been done previously)
- Malignancy (other than basal cell carcinoma) within the last 10 years
- New York Heart Association (NYHA) grade 3 or 4 congestive cardiac failure
- Demyelinating disease
See the full eligibility criteria
- Adult patients (≥18 years old), no upper age limit;
- Patient must fulfil either European Alliance of Associations for Rheumatology (EULAR)/Albumin: Creatinine Ratio (ACR) classification criteria for the diagnosis of Rheumatoid Arthritis, or Classification Criteria of Psoriatic Arthritis (CASPAR);
- Current treatment with any approved Tumour Necrosis Factor inhibitors (TNFis) for at least 6 weeks
- Active arthritis as defined by: • DAS28 score > 3.2 for Rheumatoid Arthritis • Disease Activity in Psoriatic Arthritis (DAPSA) >14 for Psoriatic Arthritis
- Signed informed consent
- Contraindications to any of the biologic treatment e.g. active infection;
- Sepsis of a prosthetic joint within 12 months or indefinitely if the joint remains in situ
- Known HIV or hepatitis B/C infection (satisfactory hepatitis B screening test must have been done previously)
- Malignancy (other than basal cell carcinoma) within the last 10 years
- New York Heart Association (NYHA) grade 3 or 4 congestive cardiac failure
- Demyelinating disease
- Any other contra-indication to the study medications as detailed in their summaries of product characteristics (SmPC), including low IgG levels at clinician’s discretion
- Receipt of live vaccine <4 weeks prior to first infusion
- Major surgery in 3 months prior to first infusion
- Presence of a transplanted organ (with the exception of a corneal transplant >3 months prior to screening)
- Known recent substance abuse (drug or alcohol)
- Previous treatment with any IL-6is (tocilizumab or sarilumab)
- Poor tolerability of venepuncture or lack of adequate venous access for required blood sampling during the study period
- Patients currently recruited to other clinical trial(s) involving an Investigational Medicinal Pproduct (IMP), except any observational follow-up periods not involving an IMP)
- Other severe acute or chronic medical or psychiatric condition, or laboratory abnormality that would impart, in the judgment of the investigator, excess risk associated with study participation or study drug administration, or which, in the judgment of the investigator, would make the patient inappropriate for entry into this study
- Women who are pregnant or breast-feeding
- Women of child-bearing potential, or males whose partners are women of child-bearing potential, unwilling to use effective contraception during the study and for at least 3 months after stopping study treatment
- History of or current primary inflammatory joint disease or primary autoimmune disease other than RA
- Intra articular or parenteral corticosteroids ≤ 4 weeks prior Visit 2
- Oral prednisolone more than 10mg per day or equivalent ≤ 4 weeks prior to Visit 2
- Active infection
- Septic arthritis within a native joint within the last 12 months
The study team makes the final eligibility decision.
Where it's taking place
- United Kingdom
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, 18-64 years, 65+ years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include United Kingdom. Enter your location above to see the nearest site and check your eligibility.
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.