Who is sponsoring NCT00367484?

NCT00367484 is sponsored by Merck KGaA, Darmstadt, Germany.

What drugs are being tested in NCT00367484?

Interventions in NCT00367484: Rebif® (clone 484-39).

What condition does NCT00367484 study?

NCT00367484 studies Relapsing Remitting Multiple Sclerosis.

Is NCT00367484 still recruiting?

NCT00367484 is currently completed. Last updated 26 January 2014.

Are results published for NCT00367484?

Yes — primary outcome results have been posted to ClinicalTrials.gov. See the outcomes section above for details.

Last reviewed 2014-01-26 · How we verify

NCT00367484

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

Multicentre, Single Arm, Open, Phase IV Study To Evaluate Immunogenicity And Safety Of Subcutaneous r-hIFN Beta-1a (Rebif®) Using Clone 484-39 In The Treatment Of Relapsing Remitting Multiple Sclerosis

Completed Phase 4 Results posted Last updated 26 January 2014

What this trial tests

Phase 4 trial testing Rebif® (clone 484-39) in Relapsing Remitting Multiple Sclerosis in 460 participants. Completed in 1 January 2006.

Timeline

1 May 2004

Primary endpoint
1 January 2006

1 January 2006

Quick facts

Lead sponsor	Merck KGaA, Darmstadt, Germany
Phase	Phase 4
Status	Completed
Study type	INTERVENTIONAL
Allocation	non randomized
Design	single group
Masking	none
Primary purpose	treatment
Enrollment	460
Start date	1 May 2004
Primary completion	1 January 2006
Estimated completion	1 January 2006

Drugs / interventions tested

Rebif® (clone 484-39) — full drug profile →

Conditions studied

Relapsing Remitting Multiple Sclerosis — all drugs for Relapsing Remitting Multiple Sclerosis →

Sponsor

Merck KGaA, Darmstadt, Germany — full company profile →

Who can join

Adults 18 to 60, any sex, with Relapsing Remitting Multiple Sclerosis. 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.

Number of Participants Testing Positive for Neutralising Antibody (NAb)
Time frame: 48 Weeks
Participants who were NAb+ at 48 weeks (or at the last available NAb assessment up to Week 48). The NAb+ value was defined as NAb ≥ 20 NU/ml.

Sponsor's own description

The objectives of the study are: \- comparison of the incidence and time course of the development of neutralizing antibodies (NAbs) to Rebif after 48 weeks of therapy, to historical data from Serono clinical trial databases to assess the safety and tolerability of Rebif®

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

Subcutaneous Interferon-β1a Does Not Increase the Risk of Stroke in Patients with Multiple Sclerosis: Analysis of Pooled Clinical Trials and Post-Marketing Surveillance.
Sabidó M, Venkatesh S, Hayward B, Aldridge J, et al · · 2018 · cited 6× · PMID 30255416 · DOI 10.1007/s12325-018-0790-1

Verify or expand the search:

Other recruiting trials for Relapsing Remitting Multiple Sclerosis

Currently open trials in the same condition.

NCT06796504 — The SetPoint System as a Pro-Remyelination Therapy for Relapsing-Remitting Multiple Sclerosis: A Pilot Study · NA · recruiting
NCT05949580 — Study to Evaluate the Usability and Value of Integrated Digital Solutions in Medical Care of Participants With Multiple · recruiting
NCT06282081 — Serum Neurofilament Light in Multiple Sclerosis · active not recruiting
NCT05327322 — Functional Outcomes From Diets in Multiple Sclerosis · NA · active not recruiting
NCT05171972 — Reduced Oligodendrocyte-specific Cytotoxicity and Ofatumumab Treatment · active not recruiting

Other Merck KGaA, Darmstadt, Germany trials

Trials by the same sponsor.

NCT03845140 — L-PZQ ODT in Schistosoma Infected Children · Phase 3 · completed
NCT03858049 — Efficacy and Safety of Crinone Versus Combination Medication (ACCESS) · Phase 4 · terminated
NCT03745144 — Effects of Cladribine Tablets on the PK of Microgynon® · Phase 1 · completed
NCT03717155 — Study of Avelumab and Cetuximab Plus Gemcitabine and Cisplatin in Participants With NSCLC · Phase 2 · completed
NCT03725072 — Human Absorption, Distribution, Metabolism and Excretion (ADME) of [14C]-Evobrutinib · Phase 1 · completed

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 NCT00367484 (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 Merck KGaA, Darmstadt, Germany
Last refreshed: 26 January 2014

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/NCT00367484.

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