Sjögren's syndrome

Helpdesk

Sales contact

Home > Therapeutic area expertise > Immunology-inflammation clinical trials > Sjögren’s syndrome

Conducting successful Sjögren's syndrome trials:

Lessons from more than a decade of eCOA experience

Sjögren’s syndrome is a chronic, autoimmune condition in which the immune system attacks moisture-producing glands. It predominantly affects women (approximately 9 to 1 female-to-male ratio) and is typically diagnosed between ages 40 and 60. Sjögren’s disease sits at the boundary of orphan status: its prevalence is around 4 per 10,000 in most registries, with heterogeneous phenotypes, high symptom variability, and long treatment horizons.

Through Phase II, Phase III and long-term extension studies, Kayentis has supported Sjögren’s syndrome programs ranging from early development to global pivotal trials involving hundreds of sites and participants across dozens of countries.

This experience has provided unique insights into the operational, technological and patient engagement requirements needed to successfully execute these studies.

10+

years of Sjögren’s eCOA experience

15+

validated instruments implemented

countries in a single program

300

sites per study

15+ validated instruments across ClinRO, PRO, injection-tolerability assessment and eDiary

ClinRO

ESSDAI · PhGA

PRO

ESSPRI · PROFAD-SSI-SF · IDEEL · PaGA · FACIT-Fatigue · HADS · SF-36 · PROMIS-Cognition · GSS · EQ-5D-5L

Injection-site tolerability

SIAQ, pre-dose and post-dose

eDiary

SSSD

Why Sjögren's Disease is a different eCOA challenge

It presents a unique combination of challenges for clinical trial sponsors. Although patient populations are relatively limited and globally dispersed, studies often require an extensive set of clinical and patient-reported endpoints, long treatment horizons, daily symptom monitoring, and increasingly complex global study footprints.

Challenge 1

Capturing fluctuating symptoms in a chronic disease

Symptoms such as dryness, fatigue and discomfort fluctuate day-to-day. Asking patients to reconstruct these fluctuations from memory at scheduled visits adds an unnecessary load on top of a chronic condition. In addition, single-visit capture misses the true disease pattern and does not allow for accurate reporting of the symptomatology.

How Kayentis addresses it:

Via a robust implementation of a daily eDiary to capture symptoms continuously between visits. This solution is enhanced, by a configurable reminder logic co-designed with patients, site-level compliance dashboards, and reconciliation against the scheduled visit’s ClinRO / PRO capture.

Challenge 2

Managing a highly demanding endpoint strategy

Sjögren’s symptom studies typically use 8-12 instruments per visit, including multiple ClinROs and PROs, which can be completed in many different formats and by various individuals. This data capture generates heavy datasets to clean and transfer.

How Kayentis addresses it:

The Kayentis platform coordinates role-based completion of eClinRO and ePRO/eObsRO inputs, visit windows, edit-checks and audit tracking, allowing transparent data capture and reporting. Integrated data management services complete the offer, with data transfer frequency remaining adjustable according to study needs.

Kayentis has developed a distinct electronic implementation of the ESSDAI:

Built in conformance with the instrument author’s requirements for electronic adaptation, and validated by sites who routinely administer the instrument and benefit from specific edit checks that reduce the risk of data entry errors and inconsistencies.
Accessible through gating process, activated only for authorized site staff.

Sponsors who have deployed the Kayentis version have described it as “an improvement on the standard ESSDAI administration experience’’.

Challenge 3

Seamless transition into long-term extensions

Parent-to-extension transitions require data collection continuity, patient identity persistence and dashboard updates to accommodate the multi-year timeframes.

How Kayentis addresses it:

Multi-year Long Term Extensions (LTE) technical builds carry diary history and account structure across the transition. In our experience, numerous Sjögren’s LTEs have run beyond five years without a break in eDiary continuity, supported by a solid project management framework and experienced teams.

Challenge 4

Injectable therapies and tolerability assessment

Self-administered biologics require patient-reported tolerability capture at every dose, using SIAQ-pre and SIAQ-post scales, tied to dose-window logic.

How Kayentis addresses it:

SIAQ-pre and SIAQ-post questionnaires are scheduled around each administration, tied to dose-window logic and eDiary reminders.

Challenge 5

Global scale despite a relatively rare population

25 to 40 countries can be selected per pivotal trial and nearly 300 sites can be active in a given study, each requiring instrument versions in local language and site training over prolonged run-in periods.

How Kayentis addresses it:

Strong processes involve parallel Language Service Provider (LSP)-supported translations, structured site training and full logistics infrastructure. In addition, a country-add workflow allows for translation availability and site enablement systematically prior to scheduled first patient visits across all participating sites.

Challenge 6

Supporting diverse patient populations

Some Sjögren’s programs require adolescent and adult branches, requiring age-appropriate versioning of instruments.

How Kayentis addresses it:

Age-appropriate branches share the same platform with the appropriate versions displayed for the relevant PROs and caregiver accounts where applicable, through sophisticated branching logic and relevant questionnaires expertise.

Sponsor need	Relevant Kayentis experience
Rapid study startup	10+ years’ experience across multiple Phase II and Phase III programs
Complex endpoint strategy	Implementation of 15+ validated instruments, including the ESSDAI with built-in data validation checks, and the CDAI that consolidates clinician and patient inputs into a single computed composite score
Daily symptom capture	Long-term eDiary deployments
LTE continuity	Multi-year extension study support
Global scale	Up to 40-country programs, and up to 300 sites per study
Adolescent populations	Age-adapted study designs and branching logic