Who is sponsoring NCT01360970?

NCT01360970 is sponsored by Lars Rombo.

What drugs are being tested in NCT01360970?

Interventions in NCT01360970: hepatitis A vaccine ( HAVRIX or EPAXAL).

What condition does NCT01360970 study?

NCT01360970 studies Response to Hepatitis A Vaccine.

Is NCT01360970 still recruiting?

NCT01360970 is currently completed. Last updated 17 November 2015.

Last reviewed 2015-11-17 · How we verify

NCT01360970

Name: Drug Landscape Pharmaceutical Database
Creator: Drug Landscape
Published: 2026-01-01
License: https://creativecommons.org/licenses/by/4.0/

Hepatitis A Vaccination in Patients With Rheumatoid Arthritis Treated With TNF-inhibitors and/or Methotrexate

Completed Phase 2 Last updated 17 November 2015

What this trial tests

Phase 2 trial testing hepatitis A vaccine ( HAVRIX or EPAXAL) in Response to Hepatitis A Vaccine in 68 participants. Completed in 1 May 2011.

Timeline

1 September 2009

Primary endpoint
1 May 2011

1 May 2011

Quick facts

Lead sponsor	Lars Rombo
Phase	Phase 2
Status	Completed
Study type	INTERVENTIONAL
Allocation	na
Design	single group
Masking	none
Primary purpose	prevention
Enrollment	68
Start date	1 September 2009
Primary completion	1 May 2011
Estimated completion	1 May 2011
Sites	4 locations across Finland, Sweden

Drugs / interventions tested

hepatitis A vaccine ( HAVRIX or EPAXAL) — full drug profile →

Conditions studied

Response to Hepatitis A Vaccine — all drugs for Response to Hepatitis A Vaccine →

Sponsor

Lars Rombo — full company profile →

Who can join

18 and older, any sex, with Response to Hepatitis A Vaccine. Patients with the condition only — healthy volunteers not accepted.

What's being measured

Primary outcomes are the specific endpoints the trial is designed to prove or disprove.

seroconversion after a single dose of hepatitis A vaccine
Time frame: one month after dose
ELISA-titers are determined before first dose and at 1 and 6 months later

Sponsor's own description

Hepatitis A vaccine is the most frequently used traveller's vaccine, yet data on its ability to induce protective immunity in immunosuppressed travellers are scarce. The investigators assess the hepatitis A virus (HAV) antibody response in patients with rheumatoid arthritis (RA) treated with Tumor Necrosis Factor (TNF) - inhibitors and/or methotrexate (Mtx).

Publications & conference data

2 peer-reviewed publications reference this trial (live from Europe PMC):

Immunomodulatory Nanosystems.
Feng X, Xu W, Li Z, Song W, et al · · 2019 · cited 252× · PMID 31508270 · DOI 10.1002/advs.201900101
Lipid-based regulators of immunity.
Johnson WT, Dorn NC, Ogbonna DA, Bottini N, et al · · 2022 · cited 8× · PMID 35600637 · DOI 10.1002/btm2.10288

Verify or expand the search:

Verify against primary sources

ClinicalTrials.gov — authoritative US registry record
WHO ICTRP — international registry index
EU Clinical Trials Register
Sponsor press releases (Google)

Data sources for this page

Trial protocol + status: ClinicalTrials.gov NCT01360970 (US National Library of Medicine, public domain)
Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by Lars Rombo
Last refreshed: 17 November 2015

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT01360970.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing