Rheumatoid Arthritis (RA)DDAS accuracyNCT07740200
Validation of the Synovo Digital Disease Activity Score (DDAS) Against Physician-Performed DAS28/CDAI: A Non-Clinical, Non-Interventional, Non-Academic Study
An observational study of Rheumatoid Arthritis (RA), run by Synovo Ltd. at 1 site in Pakistan.
Trial summary
The goal of this observational study is to assess whether the Synovo digital assessment can measure rheumatoid arthritis disease activity in adults with rheumatoid arthritis. The main questions it aims to answer are: How closely does the Synovo digital disease activity score agree with the clinician-assessed DAS28… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Rheumatoid Arthritis (RA)
- What is being tested?
- Digital Disease Activity Assessment
- Type of treatment
- Medical device
- How many people
- 61 participants
- Where
- 1 sitePakistan
- Study dates
- 24 Oct 2025to 10 Jul 2026
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Adults with clinician-confirmed rheumatoid arthritis receiving routine outpatient care at Aap Ka Clinic in Lahore, Pakistan. Participants were identified through the clinic's existing rheumatoid arthritis patient population.
Who may be able to join
- Age 18 years or older
- Any sex or gender
- Clinician-confirmed rheumatoid arthritis, consistent with established ACR/EULAR criteria or a documented routine-care diagnosis
- Receiving routine care at Aap Ka Clinic during the study period
- Able and willing to provide written informed consent
- Able to complete the DDAS assessment independently or with reasonable non-clinical assistance
- Access to a compatible smartphone or tablet and sufficient connectivity for video upload
Who cannot join
- Younger than 18 years
- Unable to provide informed consent
- A non-rheumatoid condition that substantially prevents completion or interpretation of the guided movements
- Unable to complete study procedures despite reasonable assistance
- Concurrent participation in another interventional study where participation could affect the reference or index assessments
Trial locations and contacts
1 site in 1 country.
About this study
The goal of this observational study is to assess whether the Synovo digital assessment can measure rheumatoid arthritis disease activity in adults with rheumatoid arthritis.
The main questions it aims to answer are:
How closely does the Synovo digital disease activity score agree with the clinician-assessed DAS28 score?
Can the Synovo assessment identify changes in disease activity between follow-up visits?
Participants will:
Complete a structured digital questionnaire
Record guided videos of selected joint movements using a smartphone
Undergo a standard DAS28 assessment by a clinician during the same visit
Some participants may repeat the assessments at a later follow-up visit.
Read the detailed description
Rheumatoid arthritis is a chronic inflammatory disease that can lead to pain, functional impairment, joint damage and disability. Evidence from tight-control and treat-to-target studies shows that structured and repeated measurement of disease activity, followed by timely clinical action, improves disease control and remission outcomes.
The Synovo DDAS combines patient-reported information with movement features derived from four guided smartphone videos. The system produces a continuous score calibrated to the DAS28 scale. The study evaluates the measured relationship between DDAS and clinician-derived DAS28. It does not assume interchangeability and does not test autonomous treatment decisions.
The study is designed to determine whether the DDAS demonstrates sufficient association, agreement and longitudinal tracking to justify further independent and multicenter validation. This is an exploratory, single-centre study intended to establish an initial clinical evidence base rather than definitive clinical interchangeability or regulatory-grade performance.
Primary objective: To assess the association between paired DDAS and clinician-derived DAS28 values.
Secondary objectives
- To quantify numerical agreement between DDAS and clinician-derived DAS28 using mean bias and limits of agreement, with appropriate adjustment for repeated measurements within participants.
- To assess score scaling and agreement using regression analysis and a linear mixed-effects model with a participant-level random intercept.
- To evaluate categorical agreement across the standard DAS28 disease activity bands using a confusion matrix and quadratic-weighted Cohen's kappa.
- To estimate sensitivity, specificity, positive predictive value and negative predictive value at clinically relevant DAS28 thresholds, including high disease activity, treatment target and remission.
- To assess the ability of DDAS to track the direction and magnitude of changes in clinician-derived DAS28 across repeat routine-care visits.
- Conditions
- Rheumatoid Arthritis (RA)
- Being tested
- Digital Disease Activity Assessment
- Keywords
- DDAS, Synovo, tele-rheumatology, digital health, joint movement analysis, smartphone video assessment, remote patient monitoring, digital assessment, DAS28, disease activity assessment, Rheumatoid arthritis
- Medical subject headings
- Arthritis, Rheumatoid
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Digital Disease Activity AssessmentDevice
Also called DDAS28, DDAS
Participants completed a structured digital questionnaire and recorded guided smartphone videos of selected joint movements. The resulting digital disease activity score was compared with the clinician-administered DAS28 score.
| Study group | Role | What they receive |
|---|---|---|
| Rheumatoid Arthritis Cohort | Adults with rheumatoid arthritis undergoing a Synovo digital disease activity assessment and a clinician-administered DAS28 assessment during the same visit. Some participants completed repeat paired assessments at follow-up visits. Receives: Device: Digital Disease Activity Assessment |
What is being measured
The primary outcome is the main question the study is designed to answer.
Correlation Between DDAS and Clinician-Derived DAS28
Pearson correlation coefficient between paired Synovo Digital Disease Activity Score and clinician-derived DAS28 values, reported with a 95% confidence interval.
Measured: At each paired assessment during the same clinical encounter.
Secondary outcomes (1)
Numerical Agreement Between DDAS and DAS28
Mean bias and limits of agreement between paired DDAS and DAS28 values using Bland and Altman methods adjusted for repeated measurements.
Measured: At each paired assessment during the same clinical encounter.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Jul 2026
- Study start24 Oct 2025
- Primary completion10 Jul 2026
- Study completion10 Jul 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Rheumatoid Arthritis (RA)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 61 participants (actual)
Sponsor and investigators
- Lead sponsor
- Synovo Ltd.
- Sponsor type
- University, hospital or other
- Collaborators
- Aap Ka Clinic, Akram Medical Complex
- Responsible party
- Principal investigator, Dr. Nasir Saleem Anwar Khan, Synovo Ltd.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07740200
- Sponsor's protocol ID
- 1910/Synovo/NIS/25
- Acronym
- DDAS accuracy
- Status last verified
- Jul 2026
- First submitted
- 28 Jul 2026
- Last updated
- 31 Jul 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: Individual participant data will not be made publicly available because the dataset includes sensitive health information, video-derived data and commercially confidential technical outputs. Anonymised data may be considered for access by qualified researchers under a separate written data access agreement, subject to participant consent, ethical approval, legal requirements and approval by Synovo Ltd and Aap Ka Clinic.
Publications
Bland JM, Altman DG. Agreement between methods of measurement with multiple observations per individual. J Biopharm Stat. 2007;17(4):571-82. doi: 10.1080/10543400701329422.
PubMed 17613642Creagh AP, Hamy V, Yuan H, Mertes G, Tomlinson R, Chen WH, Williams R, Llop C, Yee C, Duh MS, Doherty A, Garcia-Gancedo L, Clifton DA. Digital health technologies and machine learning augment patient reported outcomes to remotely characterise rheumatoid arthritis. NPJ Digit Med. 2024 Feb 12;7(1):33. doi: 10.1038/s41746-024-01013-y.
PubMed 38347090Nishiguchi S, Ito H, Yamada M, Yoshitomi H, Furu M, Ito T, Shinohara A, Ura T, Okamoto K, Aoyama T. Self-assessment tool of disease activity of rheumatoid arthritis by using a smartphone application. Telemed J E Health. 2014 Mar;20(3):235-40. doi: 10.1089/tmj.2013.0162. Epub 2014 Jan 3.
PubMed 24404820Prevoo ML, van 't Hof MA, Kuper HH, van Leeuwen MA, van de Putte LB, van Riel PL. Modified disease activity scores that include twenty-eight-joint counts. Development and validation in a prospective longitudinal study of patients with rheumatoid arthritis. Arthritis Rheum. 1995 Jan;38(1):44-8. doi: 10.1002/art.1780380107.
PubMed 7818570
Study at a glance
From the registry record, last updated by the sponsor on 31 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Validation of the Synovo Digital Disease Activity Score (DDAS) Against Physician-Performed DAS28/CDAI: A Non-Clinical, Non-Interventional, Non-Academic Study
- ClinicalTrials.gov ID
- NCT07740200
- Acronym / sponsor ID
- DDAS accuracy / 1910/Synovo/NIS/25
- Conditions
- Rheumatoid Arthritis (RA)
- Keywords
- DDAS, Synovo, tele-rheumatology, digital health, joint movement analysis, smartphone video assessment, remote patient monitoring, digital assessment
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 61 participants (actual)
- Lead sponsor
- Synovo Ltd.University, hospital or other
- Collaborators
- Aap Ka Clinic, Akram Medical Complex
- Study start
- 24 Oct 2025 (actual)
- Primary completion
- 10 Jul 2026 (actual)
- Study completion
- 10 Jul 2026 (actual)
- First posted
- 31 Jul 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The goal of this observational study is to assess whether the Synovo digital assessment can measure rheumatoid arthritis disease activity in adults with rheumatoid arthritis.
The main questions it aims to answer are:
How closely does the Synovo digital disease activity score agree with the clinician-assessed DAS28 score?
Can the Synovo assessment identify changes in disease activity between follow-up visits?
Participants will:
Complete a structured digital questionnaire
Record guided videos of selected joint movements using a smartphone
Undergo a standard DAS28 assessment by a clinician during the same visit
Some participants may repeat the assessments at a later follow-up visit.
Detailed description
Rheumatoid arthritis is a chronic inflammatory disease that can lead to pain, functional impairment, joint damage and disability. Evidence from tight-control and treat-to-target studies shows that structured and repeated measurement of disease activity, followed by timely clinical action, improves disease control and remission outcomes.
The Synovo DDAS combines patient-reported information with movement features derived from four guided smartphone videos. The system produces a continuous score calibrated to the DAS28 scale. The study evaluates the measured relationship between DDAS and clinician-derived DAS28. It does not assume interchangeability and does not test autonomous treatment decisions.
The study is designed to determine whether the DDAS demonstrates sufficient association, agreement and longitudinal tracking to justify further independent and multicenter validation. This is an exploratory, single-centre study intended to establish an initial clinical evidence base rather than definitive clinical interchangeability or regulatory-grade performance.
Primary objective: To assess the association between paired DDAS and clinician-derived DAS28 values.
Secondary objectives
- To quantify numerical agreement between DDAS and clinician-derived DAS28 using mean bias and limits of agreement, with appropriate adjustment for repeated measurements within participants.
- To assess score scaling and agreement using regression analysis and a linear mixed-effects model with a participant-level random intercept.
- To evaluate categorical agreement across the standard DAS28 disease activity bands using a confusion matrix and quadratic-weighted Cohen's kappa.
- To estimate sensitivity, specificity, positive predictive value and negative predictive value at clinically relevant DAS28 thresholds, including high disease activity, treatment target and remission.
- To assess the ability of DDAS to track the direction and magnitude of changes in clinician-derived DAS28 across repeat routine-care visits.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Rheumatoid Arthritis Cohort | – | Device: Digital Disease Activity AssessmentAdults with rheumatoid arthritis undergoing a Synovo digital disease activity assessment and a clinician-administered DAS28 assessment during the same visit. Some participants completed repeat paired assessments at follow-up visits. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Adults with clinician-confirmed rheumatoid arthritis receiving routine outpatient care at Aap Ka Clinic in Lahore, Pakistan. Participants were identified through the clinic's existing rheumatoid arthritis patient population.
Key inclusion criteria (7 listed)
- Age 18 years or older
- Any sex or gender
- Clinician-confirmed rheumatoid arthritis, consistent with established ACR/EULAR criteria or a documented routine-care diagnosis
- Receiving routine care at Aap Ka Clinic during the study period
- Able and willing to provide written informed consent
Key exclusion criteria (5 listed)
- Younger than 18 years
- Unable to provide informed consent
- A non-rheumatoid condition that substantially prevents completion or interpretation of the guided movements
- Unable to complete study procedures despite reasonable assistance
- Concurrent participation in another interventional study where participation could affect the reference or index assessments
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Digital Disease Activity AssessmentAlso: DDAS28, DDASParticipants completed a structured digital questionnaire and recorded guided smartphone videos of selected joint movements. The resulting digital disease activity score was compared with the clinician-administered DAS28 score. | Device | Rheumatoid Arthritis Cohort |
Primary outcome
Correlation Between DDAS and Clinician-Derived DAS28
Time frame: At each paired assessment during the same clinical encounter.
Pearson correlation coefficient between paired Synovo Digital Disease Activity Score and clinician-derived DAS28 values, reported with a 95% confidence interval.
1 secondary outcome
Numerical Agreement Between DDAS and DAS28
Time frame: At each paired assessment during the same clinical encounter.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Jul 2026.
- Results publication: PubMed 17613642Bland JM, Altman DG. Agreement between methods of measurement with multiple observations per individual. J Biopharm Stat. 2007;17(4):571-82. doi: 10.1080/10543400701329422.
- Results publication: PubMed 38347090Creagh AP, Hamy V, Yuan H, Mertes G, Tomlinson R, Chen WH, Williams R, Llop C, Yee C, Duh MS, Doherty A, Garcia-Gancedo L, Clifton DA. Digital health technologies and machine learning augment patient reported outcomes to remotely characterise rheumatoid arthritis. NPJ Digit Med. 2024 Feb 12;7(1):33. doi: 10.1038/s41746-024-01013-y.
- Results publication: PubMed 24404820Nishiguchi S, Ito H, Yamada M, Yoshitomi H, Furu M, Ito T, Shinohara A, Ura T, Okamoto K, Aoyama T. Self-assessment tool of disease activity of rheumatoid arthritis by using a smartphone application. Telemed J E Health. 2014 Mar;20(3):235-40. doi: 10.1089/tmj.2013.0162. Epub 2014 Jan 3.
- Results publication: PubMed 7818570Prevoo ML, van 't Hof MA, Kuper HH, van Leeuwen MA, van de Putte LB, van Riel PL. Modified disease activity scores that include twenty-eight-joint counts. Development and validation in a prospective longitudinal study of patients with rheumatoid arthritis. Arthritis Rheum. 1995 Jan;38(1):44-8. doi: 10.1002/art.1780380107.
- Individual participant dataSharing planned: Undecided. Individual participant data will not be made publicly available because the dataset includes sensitive health information, video-derived data and commercially confidential technical outputs. Anonymised data may be considered for access by qualified researchers under a separate written data access agreement, subject to participant consent, ethical approval, legal requirements and approval by Synovo Ltd and Aap Ka Clinic.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Rheumatoid Arthritis (RA), run by Synovo Ltd. at 1 site in Pakistan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 31 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Pakistan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Correlation Between DDAS and Clinician-Derived DAS28 (time frame: At each paired assessment during the same clinical encounter.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07740200, which also lists 4 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 31 Jul 2026.