New DocTIS clinical trial protocol published in Rheumatology Advances in Practice
A new scientific publication stemming from the DocTIS project has been published in the journal Rheumatology Advances in Practice, presenting the protocol of a clinical study exploring novel treatment strategies for immune-mediated inflammatory diseases (IMIDs).
The article, titled “Decision on optimal combinatorial therapies in immune-mediated inflammatory diseases using systems approaches (DocTIS): protocol for a single-arm, adaptive basket trial in rheumatoid and psoriatic arthritis”, describes a single-arm, multi-centre adaptive basket trial designed to evaluate the potential of combining two types of biologic therapies, tumour necrosis factor (TNF) inhibitors and interleukin-6 (IL-6) inhibitors, in patients with rheumatoid arthritis (RA) and psoriatic arthritis (PsA). This innovative trial design allows the evaluation of a shared therapeutic strategy across related diseases.
This study reports on a collaborative effort between Cardiff University and Vall d’Hebron Research Institute (VHIR), both partners of the DocTIS consortium. The work has been led by Principal Investigators Ernest Choy (Cardiff University) and Sara Marsal (VHIR), reflecting the strong integration of clinical and translational expertise within the project.
A clinical trial to evaluate combination biologic therapies
Current treatments can reduce disease activity in these conditions, but sustained remission remains difficult to achieve for many patients. The approach proposed in this study builds on previous findings from the DocTIS programme, which identified additive anti-inflammatory effects when combining TNF and IL-6 inhibitors. This approach moves beyond conventional single-drug strategies, exploring the potential of combination biologic therapies in clinical practice.
The study aims to assess whether this combinatorial strategy can significantly improve remission rates compared to standard therapies. It will include patients with RA and PsA, monitoring outcomes such as disease activity, safety and treatment tolerability over a 24-week period.
Importantly, the study represents a key step in translating the systems biology insights generated within DocTIS into clinical application. By adopting an adaptive basket trial design and exploring combination biologic therapies, it introduces an innovative approach to evaluating treatment strategies across related diseases. By integrating molecular data, clinical observations and innovative trial design, and building on multi-omics analyses generated within DocTIS, the research seeks to address one of the major challenges in IMIDs: the variability in patient response to existing treatments.
These findings may help inform future clinical studies and contribute to more effective treatment strategies in IMIDs.
Read the full article: https://academic.oup.com/rheumap/advance-article/doi/10.1093/rap/rkag036/8532537
About the project
DocTIS is a Horizon 2020 research project focused on improving treatment outcomes for immune-mediated inflammatory diseases through the identification of effective drug combinations and personalised therapeutic strategies. The project addresses six diseases: rheumatoid arthritis, psoriatic arthritis, psoriasis, ulcerative colitis, Crohn’s disease and systemic lupus erythematosus. It brings together leading academic and industry partners across Europe and beyond, combining clinical expertise, molecular data and systems biology approaches to advance precision medicine in IMIDs.
Coordinated by the Vall d’Hebron Research Institute, VHIR under the leadership of Sara Marsal, the DocTIS project brings together a multidisciplinary consortium of leading research institutions and industry partners. These include Cardiff University (Ernest Choy), the University of Verona (Giampiero Girolomoni), Charité – Universitätsmedizin Berlin (Britta Siegmund), the Institut d’Investigacions Biomèdiques August Pi i Sunyer, IDIBAPS (Pere Santamaria), the National Center for Genomic Analysis, CNAG (Holger Heyn), IMIDomics Inc. (Manuel Lopez-Figueroa), HudsonAlpha Institute for Biotechnology (Richard M. Myers) and Zabala Innovation..
