Rheumatoid ArthritisT2TRAonSSDMNCT03715595
The Treat-to-target Study of RA Based on Smart System of Disease Management(SSDM)
A study testing SSDM group in people with Rheumatoid Arthritis, run by Peking University People's Hospital at 1 site in China.
Trial summary
This study evaluate the Smart System of Disease Management（SSDM）to improve the treat-to-target(T2T) and the safety of drug in the treatment of rheumatoid(RA). All participants will be randomized in the SSDM group and the control group. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Rheumatoid Arthritis
- What is being tested?
- SSDM group
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 2,200 participants
- Where
- 1 siteChina
- Study dates
- 1 Nov 2018to 29 Jun 2020
- Phase
- Interventional
- 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
Who may be able to join
- Clinical diagnosis of Rheumatoid Arthritis.
- Have a smartphone
- Must be able to access disease activity by themselves
Who cannot join
- Not able to access disease activity by themselves
- Lacks the ability of self-management
- Mental disorders or severe physical dysfunction
- Extremely poor compliance
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Chun Li
Beijing, Beijing Municipality, 100044
Chun Li, Doctor, 8610-13811190098, 13811190098@163.com
Zhanguo Li, Doctor, 8610-13910713924, zgli99@aliyun.com
About this study
Official title: The Treat-to-target Study of Rheumatoid Arthritis Based on Smart System of Disease Management(SSDM) : A Randomized Controlled Multicenter Trial
This study evaluate the Smart System of Disease Management（SSDM）to improve the treat-to-target(T2T) and the safety of drug in the treatment of rheumatoid(RA). All participants will be randomized in the SSDM group and the control group. The patients in the SSDM group will use the SSDM every month and the control group will receive the conventional therapy.
Read the detailed description
Treat-to-Target (T2T), achieving a DAS28 score lower than 2.6 (remission, Rem) or below 3.2 (low disease activity, LDA), is the main management strategy recommended by ACR and EULAR. The Smart System of Disease Management (SSDM) is an interactive mobile disease management tool, including the doctors' and patients' application system. The patients can perform self-evaluation, including DAS28, morning stiffness duration (MSD) and HAQ, and input medical records (including medication and laboratory test results) through the mobile application. The data synchronizes to the mobiles of authorized rheumatologists through cloud data base and advices could be delivered.
- Conditions
- Rheumatoid Arthritis
- Being tested
- SSDM group
- Keywords
- treat-to-target, smart system of disease management, drug use
- Medical subject headings
- Arthritis, Rheumatoid
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SSDM groupOther
Also called control group
The patients can perform self-evaluation, including DAS28, morning stiffness duration (MSD) and HAQ, and input medical records (including medication and laboratory test results) every month.
| Study group | Role | What they receive |
|---|---|---|
| SSDM group | Experimental | The patients in will use the SSDM at home every month for one year. Receives: Other: SSDM group |
| Control group | No intervention | The patients will receive the conventional therapy for half a year. After half a year, all the patients will use the SSDM at home monthly for half a year. |
What is being measured
The primary outcome is the main question the study is designed to answer.
The rate of T2T between the two groups.
Self-reported data was reported at baseline and every month until the sixth month in the SSDM group and the patients only reported their disease at baseline and the sixth month in the control group.
Measured: six month
Secondary outcomes (9)
The rate of T2T between the two groups.
Self-reported data was reported every month until the twelve month in the two groups
Measured: twelve month
The relapse rate between the two groups
Self-reported data was reported at baseline and every month until the sixth month in the SSDM group and the patients only reported their disease at baseline and the sixth month in the control group. After 6 months， all the patients will use the SSDM for 6 months.
Measured: Six month and twelve month
The safety of drug use between the two groups
Self-reported data was reported at baseline and every month until the sixth month in the SSDM group and the patients only reported their disease at baseline and the sixth month in the control group. After 6 months， all the patients will use the SSDM for 6 months.
Measured: Six month and twelve month
The compliance between the two groups
Self-reported data was reported at baseline and every month until the sixth month in the SSDM group and the patients only reported their disease at baseline and the sixth month in the control group. After 6 months， all the patients will use the SSDM for 6 months.
Measured: Six month and twelve month
The HADS between the two groups
Self-reported data was reported at baseline and every month until the sixth month in the SSDM group and the patients only reported their disease at baseline and the sixth month in the control group. After 6 months， all the patients will use the SSDM for 6 months.
Measured: Six month and twelve month
The SF-36 between the two groups
Self-reported data was reported at baseline and every month until the sixth month in the SSDM group and the patients only reported their disease at baseline and the sixth month in the control group. After 6 months， all the patients will use the SSDM for 6 months.
Measured: Six month and twelve month
The medical economics between the two groups
Self-reported data was reported at baseline and every month until the sixth month in the SSDM group and the patients only reported their disease at baseline and the sixth month in the control group. After 6 months， all the patients will use the SSDM for 6 months.
Measured: Six month and twelve month
The numbers of active intervention by doctors between the two groups
Self-reported data was reported at baseline and every month until the sixth month in the SSDM group and the patients only reported their disease at baseline and the sixth month in the control group. After 6 months， all the patients will use the SSDM for 6 months.
Measured: Six month and twelve month
The effect of active intervention by doctors between the two groups
Self-reported data was reported at baseline and every month until the sixth month in the SSDM group and the patients only reported their disease at baseline and the sixth month in the control group. After 6 months， all the patients will use the SSDM for 6 months.
Measured: Six month and twelve month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Oct 2018
- Study start1 Nov 2018
- Primary completion29 May 2020 (estimated)
- Study completion29 Jun 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (8)Papers the sponsor has linked to this study.
- Other trials for Rheumatoid ArthritisStudies of the same condition, open and under way.
- More trials run by Peking University People's HospitalThe sponsor's other registered studies.
- 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 2,200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Peking University People's Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Anhui Provincial Hospital, The First Affiliated Hospital of Anhui Medical University, Peking University International Hospital, Xuanwu Hospital, Beijing, Dongguan People's Hospital, Sixth Affiliated Hospital, Sun Yat-sen University, Hebei General Hospital, Bethune International Peace Hospital, Central South University, The First Affiliated Hospital with Nanjing Medical University, Subei People's Hospital of Jiangsu Province, The First Affiliated Hospital of BaoTou Medical College, Linyi People's Hospital, Shandong Provincial Hospital, Mianyang Central Hospital, Tianjin Medical University General Hospital, The First People's Hospital of Yunnan, Second Affiliated Hospital, Zhejiang University, School of Medicine, Zhejiang Provincial People's Hospital, First Hospital of China Medical University, Xijing Hospital, Tianjin First Central Hospital
- Responsible party
- Sponsor
- Investigators
- Chun Li, doctor, Study director, Peking University People's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03715595
- Sponsor's protocol ID
- 2018PHB065-01
- Acronym
- T2TRAonSSDM
- Status last verified
- Jun 2020
- First submitted
- 4 Oct 2018
- Last updated
- 5 Jun 2020
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Barlow J, Turner A, Swaby L, Gilchrist M, Wright C, Doherty M. An 8-yr follow-up of arthritis self-management programme participants. Rheumatology (Oxford). 2009 Feb;48(2):128-33. doi: 10.1093/rheumatology/ken429. Epub 2008 Nov 26.
PubMed 19036778McBain H, Shipley M, Olaleye A, Moore S, Newman S. A patient-initiated DMARD self-monitoring service for people with rheumatoid or psoriatic arthritis on methotrexate: a randomised controlled trial. Ann Rheum Dis. 2016 Jul;75(7):1343-9. doi: 10.1136/annrheumdis-2015-207768. Epub 2015 Aug 19.
PubMed 26290587Dougados M, Soubrier M, Perrodeau E, Gossec L, Fayet F, Gilson M, Cerato MH, Pouplin S, Flipo RM, Chabrefy L, Mouterde G, Euller-Ziegler L, Schaeverbeke T, Fautrel B, Saraux A, Chary-Valckenaere I, Chales G, Dernis E, Richette P, Mariette X, Berenbaum F, Sibilia J, Ravaud P. Impact of a nurse-led programme on comorbidity management and impact of a patient self-assessment of disease activity on the management of rheumatoid arthritis: results of a prospective, multicentre, randomised, controlled trial (COMEDRA). Ann Rheum Dis. 2015 Sep;74(9):1725-33. doi: 10.1136/annrheumdis-2013-204733. Epub 2014 May 28.
PubMed 24872377Harrison BJ, Symmons DP, Brennan P, Barrett EM, Silman AJ. Natural remission in inflammatory polyarthritis: issues of definition and prediction. Br J Rheumatol. 1996 Nov;35(11):1096-100. doi: 10.1093/rheumatology/35.11.1096.
PubMed 8948295Krishna S, Boren SA, Balas EA. Healthcare via cell phones: a systematic review. Telemed J E Health. 2009 Apr;15(3):231-40. doi: 10.1089/tmj.2008.0099.
PubMed 19382860Marshall A, Medvedev O, Antonov A. Use of a smartphone for improved self-management of pulmonary rehabilitation. Int J Telemed Appl. 2008;2008:753064. doi: 10.1155/2008/753064.
PubMed 18615186Azevedo R, Bernardes M, Fonseca J, Lima A. Smartphone application for rheumatoid arthritis self-management: cross-sectional study revealed the usefulness, willingness to use and patients' needs. Rheumatol Int. 2015 Oct;35(10):1675-85. doi: 10.1007/s00296-015-3270-9. Epub 2015 Apr 24.
PubMed 25903352Li C, Huang J, Wu H, Li F, Zhao Y, Zhang Z, Li S, Wei H, Zhang M, Sun H, Yang J, Li Q, Li X, Qi W, Wei W, Li Y, Li Z, Wang Y, Zhang F, Wu H, Shuai Z, Wu Z, Li Y, Jia S, Jia Y, Xiao F, Mu R, Li Z. Management of Rheumatoid Arthritis With a Digital Health Application: A Multicenter, Pragmatic Randomized Clinical Trial. JAMA Netw Open. 2023 Apr 3;6(4):e238343. doi: 10.1001/jamanetworkopen.2023.8343.
PubMed 37058302
Study at a glance
From the registry record, last updated by the sponsor on 5 Jun 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Treat-to-target Study of Rheumatoid Arthritis Based on Smart System of Disease Management(SSDM) : A Randomized Controlled Multicenter Trial
- ClinicalTrials.gov ID
- NCT03715595
- Acronym / sponsor ID
- T2TRAonSSDM / 2018PHB065-01
- Conditions
- Rheumatoid Arthritis
- Keywords
- treat-to-target, smart system of disease management, drug use
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 2,200 participants (estimated)
- Lead sponsor
- Peking University People's HospitalUniversity, hospital or other
- Collaborators
- Anhui Provincial Hospital, The First Affiliated Hospital of Anhui Medical University, Peking University International Hospital, Xuanwu Hospital, Beijing, Dongguan People's Hospital, Sixth Affiliated Hospital, Sun Yat-sen University, Hebei General Hospital, Bethune International Peace Hospital, Central South University, The First Affiliated Hospital with Nanjing Medical University, Subei People's Hospital of Jiangsu Province, The First Affiliated Hospital of BaoTou Medical College, Linyi People's Hospital, Shandong Provincial Hospital, Mianyang Central Hospital, Tianjin Medical University General Hospital, The First People's Hospital of Yunnan, Second Affiliated Hospital, Zhejiang University, School of Medicine, Zhejiang Provincial People's Hospital, First Hospital of China Medical University, Xijing Hospital, Tianjin First Central Hospital
- Study start
- 1 Nov 2018 (actual)
- Primary completion
- 29 May 2020 (estimated)
- Study completion
- 29 Jun 2020 (estimated)
- First posted
- 23 Oct 2018 (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.
This study evaluate the Smart System of Disease Management（SSDM）to improve the treat-to-target(T2T) and the safety of drug in the treatment of rheumatoid(RA). All participants will be randomized in the SSDM group and the control group. The patients in the SSDM group will use the SSDM every month and the control group will receive the conventional therapy.
Detailed description
Treat-to-Target (T2T), achieving a DAS28 score lower than 2.6 (remission, Rem) or below 3.2 (low disease activity, LDA), is the main management strategy recommended by ACR and EULAR. The Smart System of Disease Management (SSDM) is an interactive mobile disease management tool, including the doctors' and patients' application system. The patients can perform self-evaluation, including DAS28, morning stiffness duration (MSD) and HAQ, and input medical records (including medication and laboratory test results) through the mobile application. The data synchronizes to the mobiles of authorized rheumatologists through cloud data base and advices could be delivered.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| SSDM group | Experimental | Other: SSDM groupThe patients in will use the SSDM at home every month for one year. |
| Control group | No intervention | –The patients will receive the conventional therapy for half a year. After half a year, all the patients will use the SSDM at home monthly for half a year. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Clinical diagnosis of Rheumatoid Arthritis.
- Have a smartphone
- Must be able to access disease activity by themselves
Key exclusion criteria (4 listed)
- Not able to access disease activity by themselves
- Lacks the ability of self-management
- Mental disorders or severe physical dysfunction
- Extremely poor compliance
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 |
|---|---|---|
| SSDM groupAlso: control groupThe patients can perform self-evaluation, including DAS28, morning stiffness duration (MSD) and HAQ, and input medical records (including medication and laboratory test results) every month. | Other | SSDM group |
Primary outcome
The rate of T2T between the two groups.
Time frame: six month
Self-reported data was reported at baseline and every month until the sixth month in the SSDM group and the patients only reported their disease at baseline and the sixth month in the control group.
9 secondary outcomes
The rate of T2T between the two groups.
Time frame: twelve month
The relapse rate between the two groups
Time frame: Six month and twelve month
The safety of drug use between the two groups
Time frame: Six month and twelve month
The compliance between the two groups
Time frame: Six month and twelve month
The HADS between the two groups
Time frame: Six month and twelve month
The SF-36 between the two groups
Time frame: Six month and twelve month
The medical economics between the two groups
Time frame: Six month and twelve month
The numbers of active intervention by doctors between the two groups
Time frame: Six month and twelve month
The effect of active intervention by doctors between the two groups
Time frame: Six month and twelve month
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Jun 2020.
- Results publication: PubMed 19036778Barlow J, Turner A, Swaby L, Gilchrist M, Wright C, Doherty M. An 8-yr follow-up of arthritis self-management programme participants. Rheumatology (Oxford). 2009 Feb;48(2):128-33. doi: 10.1093/rheumatology/ken429. Epub 2008 Nov 26.
- Results publication: PubMed 26290587McBain H, Shipley M, Olaleye A, Moore S, Newman S. A patient-initiated DMARD self-monitoring service for people with rheumatoid or psoriatic arthritis on methotrexate: a randomised controlled trial. Ann Rheum Dis. 2016 Jul;75(7):1343-9. doi: 10.1136/annrheumdis-2015-207768. Epub 2015 Aug 19.
- Results publication: PubMed 24872377Dougados M, Soubrier M, Perrodeau E, Gossec L, Fayet F, Gilson M, Cerato MH, Pouplin S, Flipo RM, Chabrefy L, Mouterde G, Euller-Ziegler L, Schaeverbeke T, Fautrel B, Saraux A, Chary-Valckenaere I, Chales G, Dernis E, Richette P, Mariette X, Berenbaum F, Sibilia J, Ravaud P. Impact of a nurse-led programme on comorbidity management and impact of a patient self-assessment of disease activity on the management of rheumatoid arthritis: results of a prospective, multicentre, randomised, controlled trial (COMEDRA). Ann Rheum Dis. 2015 Sep;74(9):1725-33. doi: 10.1136/annrheumdis-2013-204733. Epub 2014 May 28.
- Results publication: PubMed 8948295Harrison BJ, Symmons DP, Brennan P, Barrett EM, Silman AJ. Natural remission in inflammatory polyarthritis: issues of definition and prediction. Br J Rheumatol. 1996 Nov;35(11):1096-100. doi: 10.1093/rheumatology/35.11.1096.
- Results publication: PubMed 19382860Krishna S, Boren SA, Balas EA. Healthcare via cell phones: a systematic review. Telemed J E Health. 2009 Apr;15(3):231-40. doi: 10.1089/tmj.2008.0099.
- Results publication: PubMed 18615186Marshall A, Medvedev O, Antonov A. Use of a smartphone for improved self-management of pulmonary rehabilitation. Int J Telemed Appl. 2008;2008:753064. doi: 10.1155/2008/753064.
- Results publication: PubMed 25903352Azevedo R, Bernardes M, Fonseca J, Lima A. Smartphone application for rheumatoid arthritis self-management: cross-sectional study revealed the usefulness, willingness to use and patients' needs. Rheumatol Int. 2015 Oct;35(10):1675-85. doi: 10.1007/s00296-015-3270-9. Epub 2015 Apr 24.
- Derived from this study: PubMed 37058302Li C, Huang J, Wu H, Li F, Zhao Y, Zhang Z, Li S, Wei H, Zhang M, Sun H, Yang J, Li Q, Li X, Qi W, Wei W, Li Y, Li Z, Wang Y, Zhang F, Wu H, Shuai Z, Wu Z, Li Y, Jia S, Jia Y, Xiao F, Mu R, Li Z. Management of Rheumatoid Arthritis With a Digital Health Application: A Multicenter, Pragmatic Randomized Clinical Trial. JAMA Netw Open. 2023 Apr 3;6(4):e238343. doi: 10.1001/jamanetworkopen.2023.8343.
- Individual participant dataSharing planned: No
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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.
Chun Li, doctor study director
Peking University People's Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing SSDM group in people with Rheumatoid Arthritis, run by Peking University People's Hospital at 1 site in China.
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 3 inclusion and 4 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: status not confirmed, as of the sponsor's last update on 5 Jun 2020. 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 China. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Zhanguo Li, Doctor (86-10-88324178, fiona_leechun@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The rate of T2T between the two groups. (time frame: six month). 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 NCT03715595, which also lists 8 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 5 Jun 2020.