Individualised treatment strategy based on disease activity for early RA patients in usual clinical practice: The COBRA Cohort Study

Treat-to-target strategy for early RA patients in usual clinical practice: The COBRA Cohort Study - COBRA Cohort Study

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2013-003658-26-NL

Enrollment

120

Registered

2013-10-18

Start date

2013-11-13

Completion date

Unknown

Last updated

2019-06-30

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Early Active Rheumatoid Arthritis

Interventions

Trade Name: Methotrexate Product Name: Methotrexate Pharmaceutical Form: Tablet INN or Proposed INN: Methotrexate Other descriptive name

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: - RA according to the 2010 classification criteria of the American College of Rheumatology (ACR) and the European League Against Rheumatism (EULAR) (13) - Age of 18 years and older - Early RA: a diagnosis of RA of less than 2 years Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 98 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 22

Exclusion criteria

Exclusion criteria: - Prior treatment DMARDs (except hydroxychloroquine) - Insulin-dependent Diabetes mellitus - Uncontrollable non-insuline dependent diabetes mellitus - Heart failure NYHA class 3-4 - Uncontrollable hypertension - ALAT/ASAT >3 times normal values - Reduced renal function (serum creat >125 µmol/l for male and >100 µmol/l for female) - Contra-indications for methotrexate, sulphasalazine or prednisolone - Indications of probable tuberculosis - Increased risk of harm due to contraindications to the study drugs - Language problems

Design outcomes

Primary

Measure	Time frame
Primary end point(s): - EULAR good response: The main endpoint of this cohort is the disease activity measured by the percentage of patients that reach an EULAR good response (Table 3). EULAR good response is measured with the Disease Activity Score (DAS) of 44 joints: DAS44. DAS44-score is calculated with the Ritchie articular index, number of swollen joints, Erytrocyt Sedimentatie Rate (ESR), and a general health assessment on a visual analogue scale (VAS) with a range from 0 to 100 mm. The DAS44-score will be measure at each visit. EULAR good response is reached when the DAS44-score is 2.4 or less and has improved 1.2 points or more compared to the previous measurement. If this is not the case, there is moderate or none EULAR response which means intensification of the medication. ;Secondary Objective: A secondary objective of this study is to study the psychometric properties of patient reported outcomes in low disease activity and remission.;Timepoint(s) of evaluation of this end point: After 26 weeks;Main Objective: The primary objective of this study is to implement protocolised treatment according to the treat-to-target strategy, aiming at a high percentage of early rheumatoid arthritis patients with a good response to treatment at 26 weeks, in a routine clinical setting.	—

Measure

Time frame

Primary end point(s): - EULAR good response: The main endpoint of this cohort is the disease activity measured by the percentage of patients that reach an EULAR good response (Table 3). EULAR good response is measured with the Disease Activity Score (DAS) of 44 joints: DAS44. DAS44-score is calculated with the Ritchie articular index, number of swollen joints, Erytrocyt Sedimentatie Rate (ESR), and a general health assessment on a visual analogue scale (VAS) with a range from 0 to 100 mm. The DAS44-score will be measure at each visit. EULAR good response is reached when the DAS44-score is 2.4 or less and has improved 1.2 points or more compared to the previous measurement. If this is not the case, there is moderate or none EULAR response which means intensification of the medication. ;Secondary Objective: A secondary objective of this study is to study the psychometric properties of patient reported outcomes in low disease activity and remission.;Timepoint(s) of evaluation of this end point: After 26 weeks;Main Objective: The primary objective of this study is to implement protocolised treatment according to the treat-to-target strategy, aiming at a high percentage of early rheumatoid arthritis patients with a good response to treatment at 26 weeks, in a routine clinical setting.

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Secondary

Measure	Time frame
Secondary end point(s): - Functional ability: Daily physical functioning of patients is an important parameter in the treatment of patients with RA. In this cohort, we will assess the physical functioning according to the Dutch translation of the Health Assessment Questionnaire (HAQ). This is a validated questionnaire containing twenty questions, which will be filled out at baseline and after 16, 26, 39, and 52 weeks. - Remission: According to the ACR/EULAR remission criteria, there will be assessed if the patient is in remission. The ACR/EULAR definitions of remission in RA are: Boolean-based definition At any time point, patient must satisfy all of the following: Tender joint count =1 Swollen joint count =1 C-reactive protein (CRP) =1 mg/dl Patient global assessment =1 (on a 0–10 scale) Index-based definition At any time point, patient must have a Simplified Disease Activity Index (SDAI) score of =3.3, calculated from tender joint count (using 28 joints), swollen joint count (using 28 joints), patient global assessment (0–10scale), physician global assessment (0–10 scale), and CRP level (mg/dl). - Radiological progression: To assess if the treat-to-target therapy given in this cohort is effective on radiological joint damage, x-rays from hands and feet will be made at baseline, and after 16 and 52 weeks. In usual clinical practice, x-rays at baseline and after 52 weeks are routine. In this cohort we will include a x-ray after 16 weeks to be able to follow the radiological progression more closely. In case there are x-rays from less than three months before, these can be used instead of making new x-rays. - Patient Reported Outcomes (PROs): *Disease activity: During the cohort, patients will be asked to fill	—

Measure

Time frame

Secondary end point(s): - Functional ability: Daily physical functioning of patients is an important parameter in the treatment of patients with RA. In this cohort, we will assess the physical functioning according to the Dutch translation of the Health Assessment Questionnaire (HAQ). This is a validated questionnaire containing twenty questions, which will be filled out at baseline and after 16, 26, 39, and 52 weeks. - Remission: According to the ACR/EULAR remission criteria, there will be assessed if the patient is in remission. The ACR/EULAR definitions of remission in RA are: Boolean-based definition At any time point, patient must satisfy all of the following: Tender joint count =1 Swollen joint count =1 C-reactive protein (CRP) =1 mg/dl Patient global assessment =1 (on a 0–10 scale) Index-based definition At any time point, patient must have a Simplified Disease Activity Index (SDAI) score of =3.3, calculated from tender joint count (using 28 joints), swollen joint count (using 28 joints), patient global assessment (0–10scale), physician global assessment (0–10 scale), and CRP level (mg/dl). - Radiological progression: To assess if the treat-to-target therapy given in this cohort is effective on radiological joint damage, x-rays from hands and feet will be made at baseline, and after 16 and 52 weeks. In usual clinical practice, x-rays at baseline and after 52 weeks are routine. In this cohort we will include a x-ray after 16 weeks to be able to follow the radiological progression more closely. In case there are x-rays from less than three months before, these can be used instead of making new x-rays. - Patient Reported Outcomes (PROs): *Disease activity: During the cohort, patients will be asked to fill

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Countries

Netherlands

Contacts

Public ContactDepartment of Rheumatology

VU University Medical Center

l.rasch@vumc.nl

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026