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Verbanden tussen therapietrouw aan glatirameer acetaat (Copaxone) en ontvangen zorg bij patienten met aanvalsgewijze multipele sclerose.

Copaxone Adherence and Care Interrelations in Patients with Relapsing Multiple Sclerosis.

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
NL-OMON
Registry ID
NL-OMON26562
Enrollment
200
Registered
2010-07-27
Start date
2009-07-01
Completion date
Unknown
Last updated
2024-02-28

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

Conditions

Multiple sclerosis, adherence, compliance, glatiramer acetate

Interventions

None listed

Sponsors

MS4 Research Institute, Ubbergseweg 34, 6522 KJ Nijmegen, the Netherlands
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: 1. Indication for GA treatment in Relapsing Remitting MS (RRMS), as formulated by the regulatory authorities in the Netherlands; 2. Being relapse free and having stable symptoms for at least 30 days; 3. Willing and able to comply with the protocol for the duration of the study; 4. Having given written informed consent prior to any study-related procedure not part of standard neurological practice, with the understanding that the consent may be withdrawn by the patient at any time without prejudice to his/her neurological care.

Exclusion criteria

Exclusion criteria: 1. Contra-indications for GA as defined in the Summary of Product Characteristics text; 2. Hypersensitivity to glatiramer acetate or mannitol; 3. Worsening of symptoms suggestive of relapse; 4. Pregnancy or lactation.

Design outcomes

Primary

MeasureTime frame
Primary outcomes are correlations between: 1. Numbers of missed doses's; 2. Numbers of patients who discontinued GA treatment; 3. Numbers of care sessions's; 4. Duration of care per modality.

Secondary

MeasureTime frame
Secondary outcomes are (cor)relations between: 1. Number of missed doses's; 2. Numbers of patients who discontinued GA treatment; 3. Presence's; 4. Degree of socio-economic, health care, caregivers, disease, treatment and patient characteristics.

Contacts

Public ContactPeter Joseph Jongen

Ubbergseweg 34

ms4ri@kpnmail.nl+31 (0)24 3239146

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)