Pnemococcal vaccination of rheumatoid arthritis patients in biological treatment

Pneumococcal vaccination of rheumatoid arthritis patients in immunomodulatory therapy - Immunovax_RA

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2014-001299-79-DK

Enrollment

Unknown

Registered

2014-07-07

Start date

2014-10-06

Completion date

Unknown

Last updated

2017-10-02

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

Conditions

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

Interventions

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

Eligibility

Sex/Gender

All

Inclusion 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

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

Design outcomes

Primary

Measure	Time frame
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.;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.;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	—

Measure

Time frame

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.;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.;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

Measure	Time frame
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	—

Countries

Denmark

Contacts

Public ContactA. Mai Nguyen

Department of Infectious Diseases

mai.nguyen@rsyd.dk4540259507

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026