NCT00340834 (TRANSFORMS) is a Phase 3 clinical trial of Fingolimod 1.25 mg in Multiple Sclerosis, sponsored by Novartis.

Who is sponsoring NCT00340834?

NCT00340834 is sponsored by Novartis.

What drugs are being tested in NCT00340834?

Interventions in NCT00340834: Fingolimod 1.25 mg, Fingolimod 0.5 mg, Interferon β-1a 30 µg.

What condition does NCT00340834 study?

NCT00340834 studies Multiple Sclerosis.

Is NCT00340834 still recruiting?

NCT00340834 is currently completed. Last updated 18 August 2017.

Are results published for NCT00340834?

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

Last reviewed 2017-08-18 · How we verify

NCT00340834: TRANSFORMS

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

A 12-month Double-blind, Randomized, Multicenter, Active-controlled, Parallel-group Study Comparing the Efficacy and Safety of 0.5 mg and 1.25 mg Fingolimod (FTY720) Administered Orally Once Daily Versus Interferon ß-1a (Avonex) Administered im Once Weekly in Patients With Relapsing-remitting Multiple Sclerosis With Optional Extension Phase

Completed Phase 3 Results posted Last updated 18 August 2017

What this trial tests

Phase 3 trial testing Fingolimod 1.25 mg in Multiple Sclerosis in 1,292 participants. Completed in 1 July 2011.

Timeline

1 May 2006

Primary endpoint
1 July 2011

1 July 2011

Quick facts

Lead sponsor	Novartis
Phase	Phase 3
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	triple
Primary purpose	treatment
Enrollment	1,292
Start date	1 May 2006
Primary completion	1 July 2011
Estimated completion	1 July 2011
Sites	170 locations across United States, Argentina, Australia, Austria, Belgium, Brazil, Canada, Egypt

Drugs / interventions tested

Fingolimod 1.25 mg — full drug profile →
Fingolimod 0.5 mg — full drug profile →
Interferon β-1a 30 µg — full drug profile →

Conditions studied

Multiple Sclerosis — all drugs for Multiple Sclerosis →

Sponsor

Novartis — full company profile →

Who can join

Adults 18 to 55, any sex, with 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.

Estimated Annualized Aggregate Relapse Rate (ARR) in the Core Phase of the Study
Time frame: Baseline to Month 12
The ARR is defined as the number of confirmed relapses in a year. A relapse is defined as the appearance of a new or worsening of a previously stable or improving pre existing neurological abnormality, separated by at least 30 days from onset of a preceding relapse. The abnormality must be present for at least 24 hours and occur in the absence of fever or infection. The annualized ARR for each tre

Sponsor's own description

This study assessed the safety, tolerability, and efficacy of 2 doses of oral fingolimod versus interferon β-1a to reduce the frequency of relapses in patients with relapsing-remitting multiple sclerosis.

Publications & conference data

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

Oral fingolimod or intramuscular interferon for relapsing multiple sclerosis.
Cohen JA, Barkhof F, Comi G, Hartung HP, et al · · 2010 · cited 1547× · PMID 20089954 · DOI 10.1056/nejmoa0907839
Blood neurofilament light chain as a biomarker of MS disease activity and treatment response.
Kuhle J, Kropshofer H, Haering DA, Kundu U, et al · · 2019 · cited 436× · PMID 30737333 · DOI 10.1212/wnl.0000000000007032
Comparison of fingolimod with interferon beta-1a in relapsing-remitting multiple sclerosis: a randomised extension of the TRANSFORMS study.
Khatri B, Barkhof F, Comi G, Hartung HP, et al · · 2011 · cited 153× · PMID 21571593 · DOI 10.1016/s1474-4422(11)70099-0
Varicella-zoster virus infections in patients treated with fingolimod: risk assessment and consensus recommendations for management.
Arvin AM, Wolinsky JS, Kappos L, Morris MI, et al · · 2015 · cited 139× · PMID 25419615 · DOI 10.1001/jamaneurol.2014.3065
Long-term (up to 4.5 years) treatment with fingolimod in multiple sclerosis: results from the extension of the randomised TRANSFORMS study.
Cohen JA, Khatri B, Barkhof F, Comi G, et al · · 2016 · cited 123× · PMID 26111826 · DOI 10.1136/jnnp-2015-310597
Correlation between brain volume loss and clinical and MRI outcomes in multiple sclerosis.
Radue EW, Barkhof F, Kappos L, Sprenger T, et al · · 2015 · cited 120× · PMID 25632085 · DOI 10.1212/wnl.0000000000001281
Pregnancy outcomes in the clinical development program of fingolimod in multiple sclerosis.
Karlsson G, Francis G, Koren G, Heining P, et al · · 2014 · cited 108× · PMID 24463630 · DOI 10.1212/wnl.0000000000000137
Sphingosine 1-Phosphate Receptor Modulators for the Treatment of Multiple Sclerosis.
Chaudhry BZ, Cohen JA, Conway DS. · · 2017 · cited 99× · PMID 28812220 · DOI 10.1007/s13311-017-0565-4

Verify or expand the search:

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Other Novartis trials

Trials by the same sponsor.

NCT06595069 — A Real-world Study to Assess the Characteristics and Long-term Effectiveness of Inclisiran in Chinese Adult Patients · completed
NCT06632730 — Therapeutic Management and Use of Resources and Costs of Spinal Muscular Atrophy in Spain · completed
NCT06395909 — A Study to Assess the Effectiveness and Safety of Mayzent in Chinese Patients With Relapsing Forms of Multiple Sclerosis · completed
NCT06516029 — Real-World Evaluation of Patient Characteristics and Treatment Patterns Among Patients With CML-CP Treated With Ascimini · completed
NCT06644638 — Real-World Persistence and Adherence of Ofatumumab Compared to Self-Injectable and Oral DMTs in Patients With Multiple S · 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 NCT00340834 (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 Novartis
Last refreshed: 18 August 2017

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/NCT00340834.

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