ToFAcitinib in Early Active Axial SpondyloarThritis:

Launched by CHARITE UNIVERSITY, BERLIN, GERMANY · Oct 29, 2023

Keywords

ClinConnect Summary

This clinical trial is investigating a medication called tofacitinib to see how well it works in treating early active axial spondyloarthritis (axSpA), a type of inflammatory arthritis that primarily affects the spine and can cause significant back pain. The study will compare tofacitinib to a placebo (an inactive treatment) over 16 weeks, with an additional 4 weeks to check for safety. This trial is specifically for individuals aged 18 to 70 who have been diagnosed with axSpA for less than 2 years and have not responded well to at least one non-steroidal anti-inflammatory drug (NSAID).

Participants will need to have active disease, which means their symptoms are affecting them significantly, and there are clear signs of inflammation detected through medical imaging or blood tests. Throughout the study, participants will receive either the active medication or placebo and will be closely monitored for any side effects or improvement in their condition. It’s important to note that individuals with certain health issues, like infections or severe diseases, as well as pregnant or breastfeeding women, will not be eligible to join the trial. This research is crucial for understanding better treatment options for those living with early active axSpA.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • Clinical diagnosis of axSpA and fulfilment of the ASAS classification criteria
• • Symptom (back pain) duration for ≤ 2 years, according to the definition of early axial SpA by ASAS.
• • Active disease activity as defined by: BASDAI ≥4 and back pain score (BASDAI question 2) of ≥4 AND objective signs of inflammation evident by osteitis in MRI of SIJ AND/OR elevated serum CRP levels.
• Exclusion criteria:
• • active current infection, severe infections in the last 3 months
• • history of recurrent Herpes zoster or disseminated Herpes simplex
• • immunodeficiency
• • chronic Hepatitis B, C or HIV infection
• • women: pregnant or lactating (have to practice reliable method of contraception)
• • other severe diseases conflicting with a clinical study, contraindications for MRI