18 and older, any sex, with Relapsing-Remitting Multiple Sclerosis. Patients with the condition only — healthy volunteers not accepted.
Results — posted to ClinicalTrials.gov
Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.
Number of Participants With Adverse Events (AEs)Primary· Baseline up to Month 288
An AE was defined as any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. Serious AEs were defined as death, a life-threatening AE, inpatient hospitalization or prolongation of existing hospitalization, persistent or significant disability or incapacity, a congenital anomaly or birth defect, or an important medical event that jeopardized participant and required medical intervention to prevent 1 of the outcomes listed in this definition. Any AEs included both serious and non-serious AEs. A summary of other non-serious AE
Any AEs
Group
Value
95% CI
Glatiramer Acetate: Delayed Start
107
Glatiramer Acetate: Early Start
100
Serious AEs
Group
Value
95% CI
Glatiramer Acetate: Delayed Start
44
Glatiramer Acetate: Early Start
38
Change From Baseline in Kurtzke Expanded Disability Status Scale (EDSS) Score at Month 288Primary· Baseline, Month 288
The EDSS uses an ordinal scale to assess neurologic impairment in Multiple Sclerosis based on a neurological examination. Scores in each of 7 functional systems (Visual, Brain Stem, Pyramidal, Cerebellar, Sensory, Bowel and Bladder, and Cerebral) and an ambulation score were combined to determine the total EDSS score, ranging from 0 (normal) to 10 (death due to Multiple Sclerosis).
Baseline
Group
Value
95% CI
Glatiramer Acetate: Delayed Start
2.34
± 1.599
Glatiramer Acetate: Early Start
2.23
± 1.406
Change at Month 288
Group
Value
95% CI
Glatiramer Acetate: Delayed Start
1.64
± 1.962
Glatiramer Acetate: Early Start
1.06
± 1.896
Adverse events — posted to ClinicalTrials.gov
Time frame: Baseline up to Month 288.
Reporting threshold: 5%.
Adverse-event reports describe events observed during the trial — not all are caused by the drug.
Glatiramer Acetate: Delayed Start
Serious: 44/107 (41%)
Deaths: 4/107
Glatiramer Acetate: Early Start
Serious: 38/101 (38%)
Deaths: 1/101
Serious adverse events (192 terms)
Reaction
System
Glatiramer Acetate: Delaye…
Glatiramer Acetate: Early …
Chest pain
General disorders
—
—
Urinary tract infection
Infections and infestations
—
—
Dehydration
Metabolism and nutrition disorders
—
—
Depression
Psychiatric disorders
—
—
Uterine leiomyoma
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
—
—
Atrial fibrillation
Cardiac disorders
—
—
Femur fracture
Injury, poisoning and procedural complications
—
—
Tibia fracture
Injury, poisoning and procedural complications
—
—
Back pain
Musculoskeletal and connective tissue disorders
—
—
Seizure
Nervous system disorders
—
—
Anaemia
Blood and lymphatic system disorders
—
—
Myocardial infarction
Cardiac disorders
—
—
Diarrhoea
Gastrointestinal disorders
—
—
Small intestinal obstruction
Gastrointestinal disorders
—
—
Vomiting
Gastrointestinal disorders
—
—
Cholecystitis
Hepatobiliary disorders
—
—
Cellulitis
Infections and infestations
—
—
Infection
Infections and infestations
—
—
Kidney infection
Infections and infestations
—
—
Pneumonia
Infections and infestations
—
—
Sepsis
Infections and infestations
—
—
Fall
Injury, poisoning and procedural complications
—
—
Intentional overdose
Injury, poisoning and procedural complications
—
—
Road traffic accident
Injury, poisoning and procedural complications
—
—
Toxicity to various agents
Injury, poisoning and procedural complications
—
—
Other adverse events (167 terms — click to expand)
This open-label extension study will evaluate the long-term safety of glatiramer acetate and its effect on the neurologic course of participants with relapsing-remitting multiple sclerosis (RRMS). Participants have scheduled visits every 3 months to assess glatiramer acetate safety and their Multiple Sclerosis (MS) status.
Publications & conference data
2 peer-reviewed publications reference this trial (live from Europe PMC):
NCT05688436 — A Study to Learn More About The Safety of Diroximel Fumarate (VUMERITY®) in Participants Who Took it During Pregnancy An
· recruiting
NCT04079088 — Study to Evaluate Oral BIIB061 Added to Interferon-beta1 (IFN-β1) or Glatiramer Acetate in Relapsing Multiple Sclerosis
· Phase 2
· withdrawn
NCT03368664 — A Study to Evaluate Efficacy, Safety, and Tolerability of Alemtuzumab in Pediatric Patients With RRMS With Disease Activ
· Phase 3
· terminated
NCT03209479 — Copaxone Subcutaneous Injection Syringe Special Drug Use-Result Investigation (All-Case Investigation) "Prevention of Re
· completed
Other recruiting trials for Relapsing-Remitting Multiple Sclerosis
Currently open trials in the same condition.
NCT05123703 — A Study to Evaluate Safety and Efficacy of Ocrelizumab in Comparison With Fingolimod in Children and Adolescents With Re
· Phase 3
· active not recruiting
NCT05090371 — A Multicenter Study of Continued Current Therapy vs Transition to Ofatumumab After Neurofilament (NfL) Elevation
· Phase 4
· active not recruiting
NCT04530318 — Dendritic Cells Therapy Combined With Immunomodulatory Treatment in Multiple Sclerosis
· Phase 2
· active not recruiting
Other Teva Branded Pharmaceutical Products R&D, Inc. trials
Trials by the same sponsor.
NCT06664619 — A Randomized, Double-Blind, Placebo-Controlled Trial on Efficacy and Safety of Fluticasone Propionate/Albuterol Sulfate
· Phase 3
· recruiting
NCT06627231 — Mass Balance Clinical Trial With TEV-56286
· Phase 1
· completed
NCT06480552 — An Open-label Dose Escalation/Expansion Trial to Evaluate the Safety and Anti-tumor Activity of TEV-56278 Alone or in Co
· Phase 1
· recruiting
NCT06290102 — Pharmacokinetic Profile and Safety of Fluticasone Propionate and Albuterol Sulfate in Combination When Compared to Fluti
· Phase 1
· completed
NCT06253546 — Safety, Tolerability, and Pharmacokinetic Study of TV-44749 in Chinese Patients With Schizophrenia
· Phase 1
· completed
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 Teva Branded Pharmaceutical Products R&D, Inc.
Last refreshed: 18 February 2020
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/NCT00203021.