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Multi-Organ Imaging Endpoints for Autoimmune Disease Trials

Imaging endpoints in autoimmune disease trials

Autoimmune diseases can involve multiple organ systems, requiring imaging strategies that extend beyond a single anatomical region. Depending on the disease and study objective, imaging assessments may encompass joints, muscle, skin, vasculature and internal organs within the same clinical trial.

 

This complexity requires more than the application of established semi-quantitative scoring systems alone. Quantitative imaging approaches can provide additional measures of disease activity and structural change, particularly in areas such as inflammatory joint disease, myositis, skin and vascular involvement.

 

IAG combines established imaging scoring systems with advanced quantitative approaches, including DEMRIQ for dynamic contrast-enhanced MRI quantification and DAVIX for MRI-based assessment of digital vascular involvement. Through DYNAMIKA™, these assessments can be supported by standardized acquisition and centralized review across global sites.

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What our autoimmune imaging team does

Autoimmune Disease Imaging Capabilities

End-to-end BICR delivery across multiple organ systems, with proprietary quantitative measures (DEMRIQ, DAVIX) and experience managing CAR-T basket studies on a single centralized platform.

Proprietary quantitative measures
DEMRIQ and DAVIX (MRI Digital Artery Volume Index) as image-derived surrogate outcomes
CAR-T basket study management
Multiple indications managed on a single centralized platform, harmonizing MRI, CT, ultrasound and PET reads
Multi-organ read capability
Joint, muscle, skin, vascular and organ involvement in one protocol
Study Phases

How Image Analysis Group Supports Autoimmune Disease Trials.

Multi-organ imaging endpoints, delivered at the depth your current phase requires.

01 ANY PHASE
Collect & Hold

Prospective or retrospective, multi-modality image collection and archival across organ systems — analyzed when your endpoint strategy is confirmed.

Collect & Hold
02 PHASE I / II
Early Phase Trials

Exploratory quantitative measures including DEMRIQ and DAVIX to identify which imaging signal best tracks disease activity.

Early Phase Trials
03 PHASE III
Late Phase Trials

Blinded central review across joint, muscle, skin, vascular and organ involvement — including CAR-T basket designs on one platform.

Late Phase Trials
04 RWE / AI
RWE & AI Studies

Submission-ready datasets, TFLs and reader variability analyses across all assessed organ systems.

RWE & AI Studies
The experts behind your reads

Autoimmune Disease Imaging Experts

Connective tissue disease, rheumatology, dermatology and regulatory specialists — including a former FDA Division Director — shaping imaging endpoints across multi-organ autoimmune programs.

Prof. Mikael Boesen MD, PhD
Prof. Mikael Boesen Therapeutic Area Lead — IAG Scientific Advisory Board Musculoskeletal
Prof. Francesco Del Galdo MD, PhD
Prof. Francesco Del Galdo Scientific Advisor — Expert in Scleroderma Clinical Research Autoimmune
Dr. Lee S. Simon MD, FACP, FACR
Dr. Lee S. Simon Regulatory Consulting Partner — Rheumatology, Drug Development, Regulatory Affairs Pain Management
Dr. Mette Mogensen MD, PhD
Dr. Mette Mogensen Scientific Advisor — Dermato-Venereology, Inflammatory Skin Diseases Dermatology
Dr. Guillermo J. Valenzuela MD, F.A.C.R.
Dr. Guillermo J. Valenzuela Scientific Advisor — Clinical Rheumatology Expert Autoimmune
Myositis, psoriatic and rheumatoid arthritis, systemic sclerosis, lupus and autoimmune cell therapy studies, including multi-indication basket designs.

Autoimmune Indications We Support

MRI (whole-body, regional muscle, DCE-MRI) · ultrasound · FDG-PET · high-resolution CT · dedicated lung MRI · X-ray · vascular imaging · OCT

Criterion
Applies to
RAMRIS
Rheumatoid arthritis MRI scoring
PsAMRIS
Psoriatic arthritis MRI scoring
DAVIX
Proprietary — MRI Digital Artery Volume Index, digital ulcer disease
DEMRIQ
Proprietary — dynamic MRI quantification
Modified Rodnan Skin Score( mRSS)
Clinical assessment of skin involvement in systemic sclerosis
Fat fraction mapping
Myositis — chronic muscle change
Quantitative muscle volume
Myositis
Organ volumetry
SLE — organ involvement
Autoimmune Indications We Support

Indications We Cover

Myositis, psoriatic and rheumatoid arthritis, systemic sclerosis, lupus and autoimmune cell therapy studies, including multi-indication basket designs.

Idiopathic Inflammatory Myopathies / Myositis
Distinguishing active inflammation from chronic fatty replacement is the core measurement problem in myositis. We deliver quantitative muscle MRI with fat fraction mapping and muscle volume quantification, standardized across whole-body and regional acquisition.
Psoriatic Arthritis
PsAMRIS scoring is reproducible only when small-joint acquisition is tightly controlled. We harmonize protocols across sites, run reader concordance testing, and add DEMRIQ quantification for objective measures of inflammatory activity.
Rheumatoid Arthritis
Beyond RAMRIS, quantitative approaches can detect treatment effect earlier. We combine validated semi-quantitative scoring with DEMRIQ dynamic contrast-enhanced quantification, correlated to established methodology.
Systemic Sclerosis
Scleroderma spans skin, vasculature and lung within one protocol. We deliver DAVIX (MRI Digital Artery Volume Index) for digital vascular involvement alongside mRSS clinical assessment, high-resolution CT and dedicated lung MRI, with skin imaging where relevant.
Systemic Lupus Erythematosus
Lupus is multisystem by definition, so a single-region imaging strategy rarely serves the endpoint. We build multi-organ read designs with organ volumetry and joint, muscle and vascular assessment managed in one blinded workflow.
Autoimmune Cell Therapy Studies
CAR-T programmes in autoimmune disease often run multiple indications in parallel. We manage basket designs on a single centralized platform, harmonizing MRI, CT, ultrasound and PET reads across indications and sites.
One Platform Across Every Organ System

Why Sponsors Choose Image Analysis Group

DYNAMIKA™ manages multi-organ autoimmune protocols in one environment — established scoring alongside DEMRIQ and DAVIX quantification, with reader qualification per organ system and full auditability.

Centralized, secure data collection

DYNAMIKA™ unifies global imaging into a single cloud-native environment — GxP-validated, SOC 2 Type II and 21 CFR Part 11 compliant.

Real-time visibility and oversight

24/7 access to imaging status for every stakeholder, with site and reader performance tracked as the study runs.

Quality control and automated anonymization

Automated checks on receipt produce de-identified, QC-passed datasets before any read begins.

Consistent, standardized lung reads

Protocol-driven central reviews deliver standardized, reproducible assessments across relevant organ systems, combining established scoring methodologies such as RAMRIS and PsAMRIS with quantitative imaging measures, including DEMRIQ and DAVIX, where appropriate to the study
Autoimmune Diseases

Reader management and audit trails

Readers are qualified against the assessment methodology relevant to each organ system within the study. Reader assignment, blinding and adjudication workflows including 2+1 models where required are managed in-platform, with every action fully auditable.
Autoimmune Diseases

Reduced site burden, faster timelines

Simplified upload and query workflows shorten the gap between visit and usable data, and keep central reads inside the data-lock window.
GET IN TOUCH

Talk to us about your autoimmune imaging endpoint

Whether you're selecting a scoring system, designing an imaging charter, or checking scanner capability at your sites — start with a conversation.

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