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Long term effectiveness of COBRA-light and COBRA treatment in early rheumatoid arthritis

Long term effectiveness of COBRA-light and COBRA treatment in early rheumatoid arthritis - COBRA-light four year extension study

Status
Active, not recruiting
Phases
Phase 4
Study type
Observational
Source
NL-OMON
Registry ID
NL-OMON39638
Enrollment
162
Registered
2012-12-11
Start date
2013-04-04
Completion date
Unknown
Last updated
2024-04-29

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

Conditions

Rheumatoid arthritis

Interventions

None listed

Sponsors

Vrije Universiteit Medisch Centrum
Lead Sponsor

Eligibility

Age
18 Years to 99 Years

Inclusion criteria

Inclusion criteria: All patients who participated in the COBRA-light-study (and who started with the therapy).

Exclusion criteria

Exclusion criteria: Patients who did not start with the COBRA therapy

Design outcomes

Primary

MeasureTime frame
The most important parameters of the follow-up study are the status of disease activity (DAS44 score), functional capacity (HAQ score) and radiological progression (Sharp/van der Heijde score) per treatment group after 48 months. The results of both treatment groups will be compared with each other. In addition, the average disease activity, functional capacity and radiological progression of the past 48 months will be calculated and compared between treatment both groups.

Secondary

MeasureTime frame
Secondary study parameters of the study are the level of improvement of the patients (ACR response score), RA medication use, adverse events and potential additional medication use and the Charlson Comorbidity Index (CCI).

Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)