TrEatment Targets in Rheumatoid Arthritis: TETRA-study (TETRA)
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details. |
ClinicalTrials.gov Identifier: NCT06046950 |
Recruitment Status :
Recruiting
First Posted : September 21, 2023
Last Update Posted : February 26, 2024
|
- Study Details
- Tabular View
- No Results Posted
- Disclaimer
- How to Read a Study Record
Condition or disease | Intervention/treatment | Phase |
---|---|---|
Rheumatoid Arthritis | Other: Treatment target DAS28CRP-LDA Other: Treatment target SDAI-remission | Not Applicable |
Study Type : | Interventional (Clinical Trial) |
Estimated Enrollment : | 340 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | None (Open Label) |
Primary Purpose: | Treatment |
Official Title: | TrEatment Targets in Rheumatoid Arthritis: a Randomized Multi-centre, Treat to Target Strategy Trial: TETRA Study |
Actual Study Start Date : | December 20, 2023 |
Estimated Primary Completion Date : | December 2026 |
Estimated Study Completion Date : | December 2026 |
Arm | Intervention/treatment |
---|---|
Experimental: DAS28CRP-LDA
Arm that is allocated to strive for DAS28CRP low disease activity (LDA)
|
Other: Treatment target DAS28CRP-LDA
Aiming for DAS28CRP-low disease activity |
Experimental: SDAI-remission
Arm that is allocated to strive for SDAI-remission
|
Other: Treatment target SDAI-remission
Aiming for SDAI-remission |
- Achievement of the composite clinical/radiological remission outcome [ Time Frame: 18 months follow-up time point ]Achievement of the composite clinical/radiological remission outcome (radiographic progression ≤1 simple erosion narrowing score (SENS), AND, ≤1 swollen joint count, and being in PASS) at 18 months.
- The proportion of patients having radiographic progression (defined as > 1 simple erosion narrowing score (SENS) point) in both treatment arms [ Time Frame: 18 months follow-up ]
- The number of swollen joints at 18 months follow-up [ Time Frame: 18 months follow-up ]
- The proportion of patients achieving 'patient acceptable symptom state' (PASS) [ Time Frame: 18 months follow-up ]
- The proportion of patients who reach the predefined target for each treatment arm (DAS28CRP-LDA or SDAI remission) [ Time Frame: 18 months follow-up ]
- Percentage of patients that reach LDA or remission, using DAS28CRP- and SDAI-based definitions, in each treatment arm [ Time Frame: 18 months follow-up ]
- Daily functioning, measured by the Health Assessment Questionnaire-Disability Index (HAQ-DI) [ Time Frame: 18 months follow-up ]The Health Assessment Questionnaire-Disability Index (HAQ-DI) will be used to measure the impact of the rheumatoid arthritis on daily functioning. A minimum score of 0 and a maximum score of 60 can be scored. A higher score means a higher impact on daily functioning.
- Quality of life (QoL) as defined by the 'EuroQol 5 Dimensions with 5 levels' (EQ5D-5L) questionnaire [ Time Frame: 18 months follow-up ]This questionnaire assesses five dimensions of health, including mobility, self-care, usual activities, pain/discomfort and anxiety/depression. Each dimension can be answered on a 5-point scale, ranging from no problems to extreme problems/unable to. A higher score means a worse outcome.
- Incidence density rates of safety ((serious) adverse events, according to CTCAE criteria version 5.0) [ Time Frame: 18 months follow-up ]
- Drug use of the patients, consisting of the type and volume of antirheumatic drugs (glucocorticoids, DMARDS, NSAIDs) used over the 18 months period, and at 18 months visit [ Time Frame: 18 months follow-up ]
- Costs associated with medical consumption as assessed with the 'Institute for Medical Technology Assessment Medical Consumption Questionnaire' (iMCQ) [ Time Frame: 18 months follow-up ]
- Costs associated with loss of productivity as measured bij the 'Institute of Medical Technology Assessment Productivity Cost Questionnaire (iMTA PCQ) [ Time Frame: 18 months follow-up ]This is a short generic questionnaire that measures loss of productivity (e.g., both paid and unpaid work) due to illness or recovery.
- Proportion of patients of whom the rheumatologist adhered to the local guidelines to treat the patients [ Time Frame: 18 months follow-up ]Clinicians are encouraged to adhere to protocol upfront, and adherence is actively monitored, but treatment decisions are ultimately made using shared decision making between patients and physicians. After study completion, adherence will be assessed through a comparison of the target measurements and any changes in treatment regime made by the rheumatologists.
- The incidence density rate of flares [ Time Frame: 18 months follow-up ]
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
Ages Eligible for Study: | 16 Years and older (Child, Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- Diagnosis of RA (according to the 2010 or 1987 ACR/ EULAR classification criteria and/or clinical diagnosis)
- (Starting) use of a DMARD
- Aged 16 years or older
- At most low disease activity, operationalised as DAS28-CRP <3.5 (DAS28 CRP 2.9 cut off for low disease activity with measurement error 0.6) or SDAI <19 (SDAI 11 cut off for low disease activity with measurement error of 8). A state of low disease activity is required at inclusion, as for RA patients in moderate or high disease activity there is no equipoise on the best course of action (treatment needs to be escalated).
- Fluency of Dutch or English, both written and verbally; able to fill in questionnaires
- Provided informed consent
Exclusion Criteria:
- Clinical deep remission, operationalised as SDAI <3.3 or DAS28-CRP <2.4, and an taper attempt in the past 2 years that was discontinued due to occurrence of flare.
- Fewer than 3 DMARD treatment options left for this patient (severe difficult-to-treat or refractory RA)
- Current severe comorbidity or other serious life-shortening conditions hampering trial participation
- Inability to comply with the study protocol or to provide informed consent with regard to intervention control and measuring outcomes
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT06046950
Contact: Pauline Groenen, MD, MSc | 0031243272807 | p.groenen@maartenskliniek.nl |
Netherlands | |
Sint Maartenskliniek | Recruiting |
Ubbergen, Netherlands, 6574 NA | |
Contact: Pauline Groenen, MSc +3124-3272807 p.groenen@maartenskliniek.nl |
Principal Investigator: | Alfons Den Broeder, MD, PhD | Sint Maartenskliniek |
Responsible Party: | Sint Maartenskliniek |
ClinicalTrials.gov Identifier: | NCT06046950 |
Other Study ID Numbers: |
TETRA |
First Posted: | September 21, 2023 Key Record Dates |
Last Update Posted: | February 26, 2024 |
Last Verified: | December 2023 |
Studies a U.S. FDA-regulated Drug Product: | No |
Studies a U.S. FDA-regulated Device Product: | No |
Arthritis Arthritis, Rheumatoid Joint Diseases Musculoskeletal Diseases |
Rheumatic Diseases Connective Tissue Diseases Autoimmune Diseases Immune System Diseases |