Therapeutic Expertise
Rheumatology
Our rheumatology team runs trials across inflammatory and degenerative joint and connective-tissue disease, using validated composite response measures and imaging to capture reliable outcomes.
Rheumatology endpoints frequently combine composite clinical response criteria (e.g. ACR response), imaging and patient-reported outcomes. We standardise assessor training, imaging and PRO capture so that treatment effects are measured reliably and meet regulatory expectations.
Addressing common pain points in rheumatology clinical trials
Composite endpoint complexity
ACR-type composite endpoints require consistent, well-trained assessment.
We train and calibrate joint assessors and standardise composite scoring across sites.
Imaging standardisation
Structural progression endpoints depend on standardised, centrally read imaging.
We provide standardised acquisition and central reading for structural endpoints.
Placebo response in pain-driven indications
Osteoarthritis and fibromyalgia carry high placebo response.
We apply design and enrichment strategies to protect assay sensitivity.
Resources
Rheumatology clinical trial resources
Rheumatoid Arthritis Clinical Trials
Endpoint and design strategy in RA.
The Road to Osteoarthritis Drug Approval
Navigating osteoarthritis development.
The Evolving Landscape of Fibromyalgia Clinical Trials
Design considerations in fibromyalgia.
Evidence & insights
Rheumatology white papers
Open-access reports from our physicians and data science teams — free, no sign-in.
The iNGENū CRO difference
Australian expertise, direct FDA submission
We uniquely combine Australian expertise with direct FDA submission capabilities, offering a streamlined path for sponsors to achieve global approval. Trial data from Australia can be submitted directly to the FDA via our E-Gateway, eliminating the need for third-party intermediaries.
iNGENū takes a highly strategic and disciplined approach to clinical research, ensuring every dollar is directed toward generating meaningful outcomes — eliminating unnecessary costs while maintaining the highest scientific and regulatory standards across the Asia-Pacific region.
“We have been using iNGENū for a Phase 1, first-in-human trial of our investigational drug — medical writing, project management, clinical data management and full end-to-end execution and monitoring. We have been particularly impressed by the out-of-the-box creative solutions to speed up and reduce overheads during this clinical trial.”
Giles MossChief Executive Officer
Ready to discuss your Rheumatology clinical trial?
Talk to our team about how iNGENū CRO can accelerate your research.
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