STUDY OF EFFICACY AND SAFETY OF OFATUMUMAB COMPARED TO TERIFLUNOMIDE IN PATIENTS WITH RELAPSING MULTIPLE SCLEROSIS.

• Register: RPEC
• Last refreshed on: 4 September 2023
• Main ID: PER-049-16
• Date of registration: 10/05/2017
• Prospective Registration: No
• Primary sponsor: NOVARTIS BIOSCIENSES PERU S.A.,
• Public title: STUDY OF EFFICACY AND SAFETY OF OFATUMUMAB COMPARED TO TERIFLUNOMIDE IN PATIENTS WITH RELAPSING MULTIPLE SCLEROSIS.
• Scientific title: A RANDOMIZED, DOUBLE-BLIND, DOUBLE-DUMMY, PARALLEL-GROUP STUDY COMPARING THE EFFICACY AND SAFETY OF OFATUMUMAB VERSUS TERIFLUNOMIDE IN PATIENTS WITH RELAPSING MULTIPLE SCLEROSIS.
• Date of first enrolment: 02/05/2017
• Target sample size: 15
• Recruitment status: Complete
• URL: https://www.ins.gob.pe/ensayosclinicos/rpec/recuperarECPBNuevoEN.asp?numec=049-16
• Study type: Interventional
• Study design: This is phase III study, randomized, double-blind, double-dummy, active comparator-controlled, parallel-group, multi-center study with variable treatment duration in approximately 900 patients with relapsing MS. The treatment duration for individual patients will be variable based on when the End of Study (EOS) criteria are met. The maximal duration for an individual patient will be 30 months.; Eligible patients will be randomized to receive either ofatumumab 20 mg sc injections every 4 weeks (after initial loading regimen of three weekly 20 mg doses in the first 14 days) or teriflunomide 14 mg orally once daily.
• Phase: III

Countries of recruitment

Argentina, Australia, Austria, Belgium, Brazil, Bulgaria, Canada, China, Czech Republic, Denmark, Egypt, Finland, France, Germany, Hungary, India, Italy, Mexico, Norway, Poland, Portugal, Romania, Russian Federation, Spain, Taiwan, Thailand, Turkey, United States

Contacts

• Name: Jose Rodas Ortiz
• Affiliation: NOVARTIS BIOSCIENCES PERU S.A.

• Name: Rosario Valer
• Affiliation: NOVARTIS BIOSCIENCES PERU S.A.

Key inclusion & exclusion criteria

Inclusion criteria:
1. Written informed consent.
2. Male or female patients aged 18 to 55 years (inclusive) at Screening
3. Diagnosis of MS according to the 2010 Revised McDonald criteria
4. Relapsing MS: relapsing-remitting course (RRMS), or secondary progressive (SPMS) course with disease activity
5. Disability status at Screening with an EDSS score of 0 to 5.5 (inclusive)
6. Documentation of at least: 1 relapse during the previous 1 year OR 2 relapses during the previous 2 years prior to Screening OR a positive Gd-enhancing MRI scan during the year prior to randomization (Note: Screening MRI scan may be used if no positive Gd-enhancing scan exist from prior year).
7. Neurologically stable within 1 month prior to randomization.

Exclusion criteria:
1. Patients suspected of not being able or willing to cooperate or comply with study protocol requirements in the opinion of the Investigator.
2. Patients with primary progressive MS or SPMS without disease activity.
3. Patients meeting criteria for neuromyelitis optica.
4. Disease duration of more than 10 years in patients with EDSS score of 2 or less.
5. Pregnant or nursing (lactating) women.
6. Women of child-bearing potential, unless they are using highly effective methods of contraception.
7. Sexually active males, unless they agree to use a condom during active treatment.
8. Patients with an active chronic disease of the immune system other than MS or with immunodeficiency syndrome.
9. Patients with active systemic bacterial, viral or fungal infections, or known to have AIDS or to test positive for HIV antibody at Screening.
10. Patients with neurological findings consistent with PML or confirmed PML.
11. Patients at risk of developing or having reactivation of syphilis or tuberculosis.
12. Patients at risk of developing or having reactivation of hepatitis.
13. Have received any live or live-attenuated vaccines within 2 months prior to randomization.
14. Have been treated with medications as specified or within timeframes specified (e.g. corticosteroids, ofatumumab, rituximab, ocrelizumab, alemtuzumab, natalizumab, cyclophosphamide, teriflunomide, leflunomide, etc.).
15. Patients currently treated with or needing treatment with cholestyramine (unless for accelerated teriflunomide elimination) or leflunomide during the study.
16. Use of other investigational drugs at the time of Screening or within the prior 30 days, or five elimination half-lives, or until the expected pharmacodynamic effect has returned to baseline, whichever is longer.
17. History of malignancy of any organ system (other than basal cell carcinoma, in situ squamous cell carcinoma of skin, or in situ carcinoma of cervix of the uterus that have been radically treated), within the past 5 years, regardless of whether or not there is evidence of local recurrence or metastases.
18. Any of the following conditions or treatments that may impact the safety of the patient:
• History of, or current, significant cardiac disease including cardiac failure, myocardial, unstable angina, transient ischemic attack, stroke, cardiac arrhythmias requiring treatment or uncontrolled arterial hypertension
• Concomitant clinically significant cardiac arrhythmias on Screening electrocardiogram.
• History of familial long QT syndrome or known family history of Torsades de Pointe.
• History of or active severe respiratory disease.
• Patients with asthma requiring regular treatment with oral steroids.
• Severe hepatic impairment (Child-Pugh class C) or any chronic liver or biliary disease.
• Patients with severe renal impairment.
• Any medically unstable condition as determined by the Investigator.
19. Any abnormal laboratory values, according to protocol, and any other clinically significant laboratory assessment as determined by the Investigator prior to randomization.
20. Patients with severe hypoproteinaemia.
21. Patients with neurologic/psychiatric disorders, as stated in the protocol, prior to randomization.
22. Patients unable or unwilling to undergo MRI scans .
23. History of hypersensitivity to any of the study drugs or excipients (including lactose intoler

Age minimum:
Age maximum:
Gender: Both

Health Condition(s) or Problem(s) studied

-G35 Multiple sclerosis
Multiple sclerosis

G35

Multiple sclerosis

Intervention(s)

The study consists of 3 epochs; Screening epoch (including Baseline), Treatment epoch (double-blind) and Safety Follow-up (FU) epoch.
Eligible patients will be randomized in a 1:1 ratio to either the active ofatumumab 20 mg group or to the active teriflunomide 14 mg group.
On Day 1 (randomization visit), all eligible patients will be randomized to one of the treatment arms:
• Ofatumumab arm: ofatumumab 20 mg sc injections on Day 1, 7, 14, Week 4 (Study Month 1) and every 4 weeks thereafter + teriflunomide-matching placebo capsule orally once daily.
• Teriflunomide arm: teriflunomide 14 mg capsule orally once daily + ofatumumab- matching placebo injections on Day 1, 7, 14, Week 4 (Study Month 1) and every 4 weeks thereafter.
Patients who complete the double-blind Treatment epoch may be eligible to enter an open-label ofatumumab Extension study that is planned (under separate protocol). Patients who complete the Treatment epoch (on study drug), but do not enter the Extension study will be followed up for safety in the Safety Follow-up (Safety FU) for a minimum of 9 months.

Source(s) of Monetary Support

NOVARTIS BIOSCIENSES PERU S.A.

Ethics review

Status: Approved
Approval date: 14/09/2016
Contact:

[e-mail]

Clinica Anglo Americana

6168900

[e-mail]

Status: Approved
Approval date: 16/12/2016
Contact:

[e-mail]

Hospital Nacional Guillermo Almenara Irigoyen - EsSalud

999436950

[e-mail]

Status: Approved
Approval date: 16/02/2017
Contact:

[e-mail]

Hospital Nacional Dos de Mayo

3280028

[e-mail]

Results

• Results available: Yes
• Date Completed: 20/11/2019