## Protocol Section
### Identification Module
**NCT ID:** NCT02654379

**Brief Title:** Observational Study Evaluating Rituximab Use and Use of the Patient Alert Card in Participants Receiving Rituximab Infusion for a Non-Oncology Indication at Infusion Centers in Europe

**Official Title:** MabThera Drug Utilisation Study and Patient Alert Card Evaluation in Non-Oncology Patients in Europe: An Infusion Centre-Based Approach

#### Organization Study ID Info
**ID:** BA28478
#### Organization
**Class:** INDUSTRY
**Full Name:** Hoffmann-La Roche
### Status Module
#### Completion Date
**Date:** 2017-09-29

**Type:** ACTUAL

#### Expanded Access Info
#### Last Update Post Date
**Date:** 2018-04-09

**Type:** ACTUAL

**Last Update Submit Date:** 2018-04-06

**Overall Status:** COMPLETED

#### Primary Completion Date
**Date:** 2017-09-29

**Type:** ACTUAL

#### Start Date
**Date:** 2015-12-18

**Type:** ACTUAL

**Status Verified Date:** 2018-04

#### Study First Post Date
**Date:** 2016-01-13
**Type:** ESTIMATED
**Study First Submit Date:** 2016-01-11
**Study First Submit QC Date:** 2016-01-11
### Sponsor Collaborators Module

#### Lead Sponsor

**Class:** INDUSTRY

**Name:** Hoffmann-La Roche

#### Responsible Party

**Type:** SPONSOR

### Description Module

**Brief Summary:** This study is to characterize the indications for which rituximab is being used and to evaluate the use of the Patient Alert Card (PAC) in participants receiving the medication for non-oncology conditions at infusion centers. The study involves the retrospective chart review of rituximab users' medical records in non-oncology indications as well as a survey to collect information on participant characteristics, and will include questions about participant knowledge on the risk of infections, participant receipt and review of the PAC, and any actions the participant has taken as a result of receiving the PAC.

### Conditions Module

**Conditions:**

- Off-Label Use

### Design Module

#### Design Info

**Observational Model:** COHORT

**Time Perspective:** RETROSPECTIVE

#### Enrollment Info

**Count:** 1408

**Type:** ACTUAL

**Study Type:** OBSERVATIONAL

### Arms Interventions Module

#### Arm Group 1

**Description:** Cohort consisting of participants who are in the center to receive an infusion for rituximab for a non-oncology indication.

**Intervention Names:**

- Biological: Rituximab

**Label:** Cohort

### Interventions

#### Intervention 1

**Arm Group Labels:**

- Cohort

**Description:** Rituximab use in non-oncology indications

**Name:** Rituximab

**Other Names:**

- MabThera

**Type:** BIOLOGICAL

### Outcomes Module

#### Primary Outcomes

**Measure:** Percentage of Participants Aware of Known and Potential Risks of Infection Associated with Rituximab

**Time Frame:** Up to 10 months

**Measure:** Percentage of Participants Using Rituximab Off-Label

**Time Frame:** Up to 10 months

#### Secondary Outcomes

**Measure:** Disease Activity Score Based on 28 Joints (DAS28) for Participants with Rheumatoid Arthritis (RA)

**Time Frame:** Up to 10 months

**Measure:** Percentage of Participants Who Received the Patient Alert Card (PAC)

**Time Frame:** Up to 10 months

**Measure:** Percentage of Participants Who Read the PAC

**Time Frame:** Up to 10 months

**Measure:** Percentage of Participants Who Received Additional Safety-Related Materials

**Time Frame:** Up to 10 months

### Eligibility Module

**Eligibility Criteria:** Inclusion Criteria:

* Participant is in the center to receive an infusion for rituximab for a non-oncology indication during the study period
* Aged 18 years or older

Exclusion Criteria:

* Has previously already completed the rituximab survey
* Has participated in the past 12 months in a clinical trial in which rituximab was one of the treatments being evaluated.

**Minimum Age:** 18 Years

**Sampling Method:** NON_PROBABILITY_SAMPLE

**Sex:** ALL

**Standard Ages:**

- ADULT

- OLDER_ADULT

**Study Population:** Participants in the center to receive an infusion for rituximab for a non-oncology indication during the study period.

### Contacts Locations Module

#### Locations

**Location 1:**

**City:** Clermont Ferrand

**Country:** France

**Facility:** Chu De Clermont Ferrand; Hopital Gabriel Montpied

**Zip:** 63003

**Location 2:**

**City:** Corbeil Essonnes

**Country:** France

**Facility:** Centre Hospitalier Sud Francilien

**Zip:** 91106

**Location 3:**

**City:** Le Mans

**Country:** France

**Facility:** Centre Hospitalier Le Mans

**Zip:** 72037

**Location 4:**

**City:** Lille

**Country:** France

**Facility:** Hopital Claude Huriez - CHU Lille

**Zip:** 59037

**Location 5:**

**City:** Montpellier

**Country:** France

**Facility:** Hôpital Lapeyronie

**Zip:** 34295

**Location 6:**

**City:** Nantes

**Country:** France

**Facility:** CHU NANTES - Hôtel Dieu; Pharmacy

**Zip:** 44093

**Location 7:**

**City:** Paris

**Country:** France

**Facility:** Hôpital Cochin

**Zip:** 75014

**Location 8:**

**City:** Pessac

**Country:** France

**Facility:** Groupe Hospitalier Sud - Hôpital Haut-Lévêque - Centre François Magendie

**Zip:** 33600

**Location 9:**

**City:** Saint-Etienne

**Country:** France

**Facility:** CHU Saint-Etienne, Hopital Bellevue

**Zip:** 42055

**Location 10:**

**City:** Toulouse

**Country:** France

**Facility:** CHU de Toulouse - Hôpital Purpan

**Zip:** 31059

**Location 11:**

**City:** Dresden

**Country:** Germany

**Facility:** Krankenhaus Dresden-Friedrichstadt

**Zip:** 01067

**Location 12:**

**City:** Frankfurt

**Country:** Germany

**Facility:** CIRI - Centrum für Innovative Diagnostik und Therapie GmbH

**Zip:** 60528

**Location 13:**

**City:** Freiburg

**Country:** Germany

**Facility:** Universitaetsklinikum Freiburg; Innere Medizin II, Gastroenterologie

**Zip:** 79106

**Location 14:**

**City:** Halle

**Country:** Germany

**Facility:** Private Practice Dr. A. Liebhaber

**Zip:** 06128

**Location 15:**

**City:** Heidelberg

**Country:** Germany

**Facility:** Universitätsklinikum Heidelberg

**Zip:** 69120

**Location 16:**

**City:** Lübeck

**Country:** Germany

**Facility:** Universitätsklinikum Schleswig-Holstein; Campus Lübeck

**Zip:** 23538

**Location 17:**

**City:** Mainz

**Country:** Germany

**Facility:** Universitaetsmedizin der Johannes Gutenberg-Universitaet Mainz

**Zip:** 55101

**Location 18:**

**City:** Ratingen

**Country:** Germany

**Facility:** Rheumazentrum Ratingen - Studienambulanz

**Zip:** 40878

**Location 19:**

**City:** Vogelsang-Gommern

**Country:** Germany

**Facility:** Fachkrankenhaus Vogelsang

**Zip:** 39245

**Location 20:**

**City:** Ferrara

**Country:** Italy

**Facility:** Azienda Ospedaliera Universitaria Arcispedale S. Anna

**State:** Emilia-Romagna

**Zip:** 44100

**Location 21:**

**City:** Roma

**Country:** Italy

**Facility:** IDI-Istituto Dermopatico dell'Immacolata IRCCS

**State:** Lazio

**Zip:** 00167

**Location 22:**

**City:** Milano

**Country:** Italy

**Facility:** Asst Centro Specialistico Ortopedico Traumato-Logico Gaetano Pini/Cto

**State:** Lombardia

**Zip:** 20122

**Location 23:**

**City:** Milano

**Country:** Italy

**Facility:** Ospedale San Raffaele

**State:** Lombardia

**Zip:** 20132

**Location 24:**

**City:** Torino

**Country:** Italy

**Facility:** Ospedale San Giovanni Bosco

**State:** Piemonte

**Zip:** 10154

**Location 25:**

**City:** Cagliari

**Country:** Italy

**Facility:** Azienda Ospedaliera Giuseppe Brotzu

**State:** Sardegna

**Zip:** 09131

**Location 26:**

**City:** Firenze

**Country:** Italy

**Facility:** Azienda Ospedaliera Universitaria Careggi

**State:** Toscana

**Zip:** 50141

**Location 27:**

**City:** Pisa

**Country:** Italy

**Facility:** Azienda Ospedaliero Universitaria Pisana

**State:** Toscana

**Zip:** 56100

**Location 28:**

**City:** Siena

**Country:** Italy

**Facility:** A.O.U. Senese Policlinico Santa Maria Alle Scotte

**State:** Toscana

**Zip:** 53100

**Location 29:**

**City:** Sabadell

**Country:** Spain

**Facility:** Corporacio Sanitaria Parc Tauli

**State:** Barcelona

**Zip:** 08208

**Location 30:**

**City:** A Coruña

**Country:** Spain

**Facility:** Complejo Hospitalario Universitario A Coruña

**State:** LA Coruña

**Zip:** 15006

**Location 31:**

**City:** Málaga

**Country:** Spain

**Facility:** Hospital Regional Universitario de Malaga; Servicio de Reumatologia

**State:** Malaga

**Zip:** 29009

**Location 32:**

**City:** Vigo

**Country:** Spain

**Facility:** Hospital Meixoeiro

**State:** Pontevedra

**Zip:** 36214

**Location 33:**

**City:** Seville

**Country:** Spain

**Facility:** Hospital Universitario Virgen Macarena

**State:** Sevilla

**Zip:** 41071

**Location 34:**

**City:** Barcelona

**Country:** Spain

**Facility:** Hospital de la Santa Creu i Sant Pau

**Zip:** 08041

**Location 35:**

**City:** Barcelona

**Country:** Spain

**Facility:** Hospital Universitari de Bellvitge; Servicio de Reumatologia

**Zip:** 08907

**Location 36:**

**City:** Granada

**Country:** Spain

**Facility:** Hospital Universitario San Cecilio

**Zip:** 18012

**Location 37:**

**City:** Madrid

**Country:** Spain

**Facility:** Hospital Universitario Clínico San Carlos

**Zip:** 28040

**Location 38:**

**City:** Madrid

**Country:** Spain

**Facility:** Hospital Universitario 12 de Octubre

**Zip:** 28041

**Location 39:**

**City:** Valladolid

**Country:** Spain

**Facility:** Hospital Clinico Universitario Valladolid

**Zip:** 47005

**Location 40:**

**City:** Bristol

**Country:** United Kingdom

**Facility:** Bristol Royal Infirmary

**Zip:** BS2 8HW

**Location 41:**

**City:** Cambridge

**Country:** United Kingdom

**Facility:** Addenbrooke's Hospital

**Zip:** CB2 0QQ

**Location 42:**

**City:** Colchester

**Country:** United Kingdom

**Facility:** Southend University Hospital

**Zip:** C03 3NB

**Location 43:**

**City:** Exeter

**Country:** United Kingdom

**Facility:** Royal Devon and Exeter Hospital (Wonford)

**Zip:** EX2 5DW

**Location 44:**

**City:** Plymouth

**Country:** United Kingdom

**Facility:** Derriford Hospital

**Zip:** PL6 8DH

**Location 45:**

**City:** Salford

**Country:** United Kingdom

**Facility:** Salford Royal

**Zip:** M6 8HD

**Location 46:**

**City:** Torquay

**Country:** United Kingdom

**Facility:** Torbay Hospital

**Zip:** TQ2 7AA

**Location 47:**

**City:** Truro

**Country:** United Kingdom

**Facility:** Royal Cornwall Hospital

**Zip:** TR1 3LQ

**Location 48:**

**City:** Wolverhampton

**Country:** United Kingdom

**Facility:** New Cross Hospital

**Zip:** WV10 0QP

#### Overall Officials

**Official 1:**

**Affiliation:** Hoffmann-La Roche

**Name:** Clinical Trials

**Role:** STUDY_DIRECTOR

### References Module

#### References

**Citation:** Sarsour K, Beckley-Kartey S, Melega S, Odueyungbo A, Kirchner P, Khalife N, Bangs J. Rituximab utilization for approved and off-label nononcology indications and patients' experiences with the Patient Alert Card. Pharmacol Res Perspect. 2020 Jan 3;8(1):e00555. doi: 10.1002/prp2.555. eCollection 2020 Feb.

**PMID:** 31911839

## Derived Section

### Intervention Browse Module - Ancestors

- ID: D000074322

- Term: Antineoplastic Agents, Immunological

- ID: D000000970

- Term: Antineoplastic Agents

- ID: D000007155

- Term: Immunologic Factors

- ID: D000045505

- Term: Physiological Effects of Drugs

- ID: D000018501

- Term: Antirheumatic Agents

### Intervention Browse Module - Browse Branches

- Abbrev: ANeo

- Name: Antineoplastic Agents

- Abbrev: ARhu

- Name: Antirheumatic Agents

- Abbrev: All

- Name: All Drugs and Chemicals

### Intervention Browse Module - Browse Leaves

- ID: M373

- Name: Rituximab

- Relevance: HIGH

- As Found: Healthy

- ID: M1346

- Name: Antineoplastic Agents, Immunological

- Relevance: LOW

- As Found: Unknown

- ID: M10201

- Name: Immunologic Factors

- Relevance: LOW

- As Found: Unknown

- ID: M20604

- Name: Antirheumatic Agents

- Relevance: LOW

- As Found: Unknown

### Intervention Browse Module - Meshes

- ID: D000069283

- Term: Rituximab

### Misc Info Module

- Version Holder: 2024-05-24
