Study identification

PURI

https://redirect.ema.europa.eu/resource/3394

EU PAS number

EUPAS3393

Study ID

3394

Official title and acronym

Evaluation of a Standardized Protocol for Dose Reduction in Patients With Spondylarthropathies and Clinical Remission With Anti-TNF Therapy (REDES-TNF/2012)

DARWIN EU® study

No

Study countries

Spain

Study description

It has been shown that the withdrawal of treatment follows with a flare of the disease in a short time after the suspension but it has not been evaluated in controlled trials if remission could be maintained with a lower dose. A multicenter, national, open-label, randomized and controlled clinical trial of 3 years duration (2 years for inclusion + 1 year follow-up) is proposed to address this issue. The study will include 190 patients with Spondylarthropathies in stable treatment with any single anti-TNF agent and compliance with criteria of clinical remission for at least 4 months. Patients will be randomized to intervention or control arm, with stratification according to the antiTNF product thet were receiving prior to inclusion. Patients will be followed with the calendar of visits recommended by the Spanish Society of Rheumatology for clinical practice. The proposed hypothesis is of non-inferiority of the experimental arm with dose reduction versus the control arm with standard treatment.

Study status

Ongoing
Research institution and networks

Institutions

Reumatology Service
Hospital Universitario Central de Asturias Oviedo, Asturias, Spain, Hospital Monte Naranco Oviedo, Asturias, Spain, Hospital General de Llerena-Zafra Llerena, Badajoz, Spain, Hospital Universitario de Bellvitge Hospitalet de Llobregat, Barcelona, Spain, Corporació Sanitària Parc Taulí Sabadell, Barcelona, Spain, Hospital de Sant Joan Despí Moisès Broggi Sant Joan Despí, Barcelona, Spain, Hospital Comarcal de Palamós Palamós, Girona, Spain, Hospital Son Llàtzer Palma de Mallorca, Illes Balears, Spain, Hospital Universitario de Gran Canaria Dr. Negrín Las Palmas de Gran Canaria, Las Palmas, Spain, Hospital Universitario Príncipe de Asturias Alcalá de Henares, Madrid, Spain

Networks

GRESSER-SEFC (REDES)

Contact details

Jordi Gratacós

Primary lead investigator
Study timelines

Date when funding contract was signed

Planned:

Study start date

Planned:
Actual:

Data analysis start date

Planned:

Date of final study report

Planned:
Sources of funding
Other

More details on funding

Instituto de Salud Carlos III
Study protocol
Initial protocol

02 Protocolo_REDES_ 15 diciembre (1)_Version final

English (529.02 KB - PDF)View document
Regulatory

Was the study required by a regulatory body?

No

Is the study required by a Risk Management Plan (RMP)?

Not applicable