Pnemococcal vaccination of rheumatoid arthritis patients in biological treatment

• Register: EUCTR
• Last refreshed on: 2 October 2017
• Main ID: EUCTR2014-001299-79-DK
• Date of registration: 07/07/2014
• Prospective Registration: Yes
• Primary sponsor: Department of Infectious Diseases, Odense University Hospital
• Public title: Pnemococcal vaccination of rheumatoid arthritis patients in biological treatment
• Scientific title: Pneumococcal vaccination of rheumatoid arthritis patients in immunomodulatory therapy - Immunovax_RA
• Date of first enrolment: 06/10/2014
• Recruitment status: Not Recruiting
• URL: https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2014-001299-79
• Study type: Interventional clinical trial of medicinal product
• Study design: Controlled: yes Randomised: yes Open: yes Single blind: no Double blind: no Parallel group: yes Cross over: no Other: no If controlled, specify comparator, Other Medicinial Product: yes Placebo: no Other: yes Other specify the comparator: Prevenar 13, Pneumovax Number of treatment arms in the trial: 4
• Phase: Human pharmacology (Phase I): no Therapeutic exploratory (Phase II): no Therapeutic confirmatory - (Phase III): yes Therapeutic use (Phase IV): no

Countries of recruitment

Denmark

Contacts

• Name: A. Mai Nguyen
• Affiliation: Department of Infectious Diseases

• Name: A. Mai Nguyen
• Affiliation: Department of Infectious Diseases

Key inclusion & exclusion criteria

Inclusion criteria:
- Diagnosed with rheumatoid arthritis
- Over 18 years old
- Not pregnant
- Receiving immunomodulatory therapy for rheumatoid arthritis (for randomized group)
- Patient at theumatology outpatient clinic at Odense University Hospital or King Christian X's Hospital for Rheumatic Diseases
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 2
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 98

Exclusion criteria:
- Hypersensitivity to diphtheria toxoid, active substance or excipients in the vaccines.
- Pneumovax vaccination within the last 12 months
- Refuses to be vaccinated


Age minimum:
Age maximum:
Gender:
Female: yes
Male: yes

Health Condition(s) or Problem(s) studied

Immunoresponse on pneumococcal vaccination of rheumatoid arthritis patients in immunomodulatory therapy
MedDRA version: 18.0 Level: LLT Classification code 10069594 Term: Pneumococcal immunization System Organ Class: 100000004865

Therapeutic area: Diseases [C] - Bacterial Infections and Mycoses [C01]

Intervention(s)

Trade Name: Prevenar 13
Pharmaceutical Form: Suspension for injection
INN or Proposed INN: pneumococcal polysaccharide serotype 1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F and 23F
Other descriptive name: PNEUMOCOCCAL POLYSACCHARIDE CONJUGATE VACCINE (13-VALENT, ADSORBED) CONJUGATED TO CRM197 CARRIER PROTEIN AND ADSORBED ON ALUMINIUM PHOSPHATE
Concentration unit: µg/ml microgram(s)/millilitre
Concentration type: equal
Concentration number: 30.8-

Trade Name: Pneumovax
Pharmaceutical Form: Suspension for injection
INN or Proposed INN: pneumococcal polysaccharide serotype 1, 2, 3, 4, 5, 6B, 7F, 8, 9N, 9V, 10A, 11A, 12F, 14, 15B, 17F, 18C, 19A, 19F, 20, 22F, 23F and 33F
Other descriptive name: PNEUMOCOCCAL POLYSACCHARIDE VACCINE (23 VALENT)
Concentration unit: µg/ml microgram(s)/millilitre
Concentration type: equal
Concentration number: 575-

Primary Outcome(s)

Secondary Objective: A comparison of the specific pneumococcal antibody level pre and postvaccination (for Prevenar and Pneumovax) in the different treatment groups dependent on the treatment for rheumatoid arthritis.

Main Objective: A direct head-to-head comparison of the specific pneumococcal antibody level pre and post vaccination in the different study groups, for Prevenar and Pneumovax, independently of treatment for rheumatoid arthritis.

Primary end point(s): The primary endpoint is a head-to-head comparison of the specifik pneumococcal antibody titer pre and post vaccination in the different study groups, independent of the treatment for rheumatoid arthritis.

Timepoint(s) of evaluation of this end point: Medio 2016

Secondary Outcome(s)

Secondary end point(s): A comparison of the specific pneumococcal antibody titer pre and post vaccination in the different study groups, dependent on the treatment for rheumatoid arthritis.

Timepoint(s) of evaluation of this end point: Medio 2016

Secondary ID(s)

IMVX2014

Source(s) of Monetary Support

University of Southern Denmark

Department of Infectious Diseases

Fondation Idella

Region of Southern Denmark