Study to Assess Medication Satisfaction in Patients With Relapsing Remitting Multiple Sclerosis Treated With Copaxone®

NCT02499900 | Completed Phase 4 Results FDA Drug

• 2 other identifiers: TV44400-CNS-400832015-000922-12
• Study Type: interventional
• Target: 861
• Locations: 16 countries
• Sites: 97

Brief Summary

The primary objective of this study is to compare patient medication satisfaction as measured by the Medication Satisfaction Questionnaire (MSQ) scores between the Copaxone 40 mg/mL three time a week (TIW) group and the Copaxone 20 mg/mL once daily (QD) group over 6 months of treatment.

Conditions

Multiple Sclerosis

Outcome Measures

Primary Outcomes (1)

• Change From Baseline in the Medication Satisfaction Questionnaire (MSQ) to Month 6 Using a Repeated Measures ANCOVA

  Patient satisfaction with the study medication was assessed using the MSQ a 1-item global patient-rated scale. Patients were asked to respond on a 7-point scale, ranging from extremely dissatisfied (1) to extremely satisfied (7), to the following: "Overall, how satisfied are you with your current medication?". Positive change from baseline score indicates greater satisfaction with the medication. Estimates and p-value are obtained from baseline-adjusted repeated measures ANCOVA model with visit as a repeated effect: MSQ=baseline MSQ score+treatment+visit+treatment by visit interaction.

  Baseline (Month 0), Months 1, 3 and 6

Secondary Outcomes (5)

• Change From Baseline in the Treatment Satisfaction Questionnaire for Medication 9-item Version (TSQM-9) Convenience Score to Month 6 Using a Repeated Measures ANCOVA

  Baseline (Month 0), Months 1, 3 and 6

• Change From Baseline in the Modified Fatigue Impact Scale (MFIS) Total Score and Subscales to Month 6 Using a Repeated Measures ANCOVA

  Baseline (Month 0), Months 1, 3 and 6

• Change From Baseline in the Mental Health Index (MHI) Total Score and Subscales to Month 6 Using a Repeated Measures ANCOVA

  Baseline (Month 0), Months 1, 3 and 6

• Change From Baseline in the Beck Depression Inventory II (BDI-II) Total Score to Month 6 Using a Repeated Measures ANCOVA

  Baseline (Month 0), Months 1, 3 and 6

• Participants With Treatment-Emergent Adverse Events (TEAEs) During Both the Core Period and Extension Periods

  Core: Day 1 to Month 6 Extension: Month 7 to Month 12

Study Arms (2)

Copaxone® 40 mg/mL

EXPERIMENTAL

Subcutaneous Injections 40 mg/mL Three Times a Week for the core period which last 6 months. In the extension period patient are administered Copaxone® 40 mg/mL for months 7 - 12.

Drug: Copaxone®

Copaxone® 20 mg/mL

ACTIVE COMPARATOR

Subcutaneous Injections 20 mg/mL Daily for the core period which last 6 months. In the extension period patient are administered Copaxone® 40 mg/mL for months 7 - 12.

Drug: Copaxone®

Interventions

Copaxone® DRUG

Subcutaneous Injections

Also known as: Glatiramer Acetate

Copaxone® 20 mg/mL; Copaxone® 40 mg/mL

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Men or women at least 18 years of age or older.
• Patients must have a confirmed and documented RRMS diagnosis
• Patients must be ambulatory with a Kurtzke EDSS score of 0 to 5.5 at screening visit.
• Patients must be in a stable neurological condition, relapse-free and free of any corticosteroid treatment 30 days prior to randomization.
• Women of child-bearing potential must have a negative urine pregnancy test at screening visit and must practice an acceptable method of birth
• Patients must be able to sign and date a written informed consent prior to entering the study.
• Patients must be willing and able to comply with the protocol requirements for the duration of the study.

You may not qualify if:

• Patient had any contraindication to Copaxone therapy.
• Previous use of Copaxone 40 mg/mL three times per week.
• Patients with progressive forms of MS.
• Patients with neuromyelitis optica.
• Use of experimental or investigational drugs, and/or participation in drug clinical studies within the 6 months prior to screening.
• Patients who have been treated with; immunosuppressive medications, immunoglobulins and/or monoclonal antibodies, alemtuzumab, cladribine, cyclophosphamide or mitoxantrone at any time
• Chronic (more than 30 consecutive days) systemic (IV, PO or IM) corticosteroid treatment within 6 months prior to screening visit.
• Pregnancy or breastfeeding.
• Clinically significant or unstable medical or surgical condition that would preclude safe and complete study participation
• Employees of the clinical study site or any other individuals involved with the conduct of the study, or immediate family members of such individuals
• other criteria may apply, please contact the investigator for more information

Sponsors & Collaborators

• Teva Branded Pharmaceutical Products R&D, Inc.: lead

Study Sites (97)

Teva Investigational Site 13485

Cullman, Alabama, 35058-1565, United States

Location

Teva Investigational Site 13524

Carmichael, California, 95608, United States

Location

Teva Investigational Site 13478

Atlanta, Georgia, 30327, United States

Location

Teva Investigational Site 13475

Northbrook, Illinois, 60062, United States

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Teva Investigational Site 13472

Foxborough, Massachusetts, 02035, United States

Location

Teva Investigational Site 13479

Golden Valley, Minnesota, 55422, United States

Location

Teva Investigational Site 13483

Golden Valley, Minnesota, 55422, United States

Location

Teva Investigational Site 13487

Las Vegas, Nevada, 89106, United States

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Teva Investigational Site 13470

Teaneck, New Jersey, 07666, United States

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Teva Investigational Site 13482

New Hyde Park, New York, 11042, United States

Location

Teva Investigational Site 13471

Raleigh, North Carolina, 27607, United States

Location

Teva Investigational Site 13473

Columbus, Ohio, 43214, United States

Location

Teva Investigational Site 13477

Uniontown, Ohio, 44685, United States

Location

Teva Investigational Site 13481

Round Rock, Texas, 78681, United States

Location

Teva Investigational Site 13480

Virginia Beach, Virginia, 23456, United States

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Teva Investigational Site 20061

Buenos Aires, C1061ABD, Argentina

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Teva Investigational Site 20062

Buenos Aires, C1280AEB, Argentina

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Teva Investigational Site 20063

Rosario, S2002KQJ, Argentina

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Teva Investigational Site 33040

Vienna, 1010, Austria

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Teva Investigational Site 37066

Brussels, 1200, Belgium

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Teva Investigational Site 37063

Edegem, 2650, Belgium

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Teva Investigational Site 60037

Rijeka, 51000, Croatia

Location

Teva Investigational Site 60039

Slavonski Brod, 35000, Croatia

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Teva Investigational Site 60034

Zagreb, 10000, Croatia

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Teva Investigational Site 60035

Zagreb, 10000, Croatia

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Teva Investigational Site 60036

Zagreb, 10000, Croatia

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Teva Investigational Site 60040

Zagreb, 10000, Croatia

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Teva Investigational Site 40014

Tampere, 33100, Finland

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Teva Investigational Site 40015

Turku, 20520, Finland

Location

Teva Investigational Site 35211

Besançon, 25030, France

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Teva Investigational Site 35203

Bordeaux, 33076, France

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Teva Investigational Site 35207

Bron, 69677, France

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Teva Investigational Site 35210

Clermont-Ferrand, 63003, France

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Teva Investigational Site 35208

Lille, 59000, France

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Teva Investigational Site 35214

Lomme, 59160, France

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Teva Investigational Site 35204

Nancy, 54035, France

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Teva Investigational Site 35205

Nice, 6002, France

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Teva Investigational Site 35206

Nîmes, 30029, France

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Teva Investigational Site 35212

Nîmes, 30029, France

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Teva Investigational Site 35213

Poissy, 78303, France

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Teva Investigational Site 35202

Rennes, 35033, France

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Teva Investigational Site 35201

Strasbourg, 67091, France

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Teva Investigational Site 35209

Toulouse, 31059, France

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Teva Investigational Site 32605

Bayreuth, 95445, Germany

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Teva Investigational Site 32603

Dresden, ?01307, Germany

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Teva Investigational Site 32602

Hamburg, 20249, Germany

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Teva Investigational Site 32606

Rostock, 18147, Germany

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Teva Investigational Site 32604

Stuttgart, 70174, Germany

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Teva Investigational Site 44029

Dublin, Ireland

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Teva Investigational Site 30169

Bari, 70124, Italy

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Teva Investigational Site 30163

Genova, 16132, Italy

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Teva Investigational Site 30165

Milan, 20122, Italy

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Teva Investigational Site 30164

Milan, 20127, Italy

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Teva Investigational Site 30161

Montichiari, 25018, Italy

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Teva Investigational Site 30167

Naples, 80131, Italy

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Teva Investigational Site 30166

Rome, ?00133, Italy

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Teva Investigational Site 30162

Rome, ?00152, Italy

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Teva Investigational Site 21096

DF, 03310, Mexico

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Teva Investigational Site 21097

Mexico City, 14050, Mexico

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Teva Investigational Site 21095

Mexico City, 14269, Mexico

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Teva Investigational Site 21098

Mexico City, 3100, Mexico

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Teva Investigational Site 53352

Bydgoszcz, 85-795, Poland

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Teva Investigational Site 53354

Gdansk, 80-803, Poland

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Teva Investigational Site 53353

Gmina Końskie, 26-200, Poland

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Teva Investigational Site 53350

Katowice, 40-635, Poland

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Teva Investigational Site 53349

Kielce, 25-726, Poland

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Teva Investigational Site 53356

Lodz, 90-324, Poland

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Teva Investigational Site 53348

Lodz, 90-549, Poland

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Teva Investigational Site 53345

Lublin, 20-016, Poland

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Teva Investigational Site 53355

Olsztyn, 10-560, Poland

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Teva Investigational Site 53351

Rybnik, 44-200, Poland

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Teva Investigational Site 53347

Rzeszów, 35-055, Poland

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Teva Investigational Site 53346

Warsaw, ?00-909, Poland

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Teva Investigational Site 13476

Guaynabo, 00969, Puerto Rico

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Teva Investigational Site 50392

Kaluga, 248007, Russia

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Teva Investigational Site 50390

Kazan', 420021, Russia

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Teva Investigational Site 50391

Krasnoyarsk, 660049, Russia

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Teva Investigational Site 50387

Moscow, 125367, Russia

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Teva Investigational Site 50374

Moscow, 127015, Russia

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Teva Investigational Site 50373

Moscow, 603003, Russia

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Teva Investigational Site 50376

Novosibirsk, 630007, Russia

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Teva Investigational Site 50389

Perm, Russia

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Teva Investigational Site 50377

Saint Petersburg, 194044, Russia

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Teva Investigational Site 50375

Saint Petersburg, 197110, Russia

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Teva Investigational Site 50372

Tyumen, 625048, Russia

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Teva Investigational Site 50378

Yaroslavl, 150030, Russia

Location

Teva Investigational Site 31181

Burgos, 09006, Spain

Location

Teva Investigational Site 31179

El Palmar, 30120, Spain

Location

Teva Investigational Site 31180

Madrid, 28006, Spain

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Teva Investigational Site 31177

Málaga, 29010, Spain

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Teva Investigational Site 31182

Seville, 41009, Spain

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Teva Investigational Site 31184

Seville, 41010, Spain

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Teva Investigational Site 31178

Valencia, 46026, Spain

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Teva Investigational Site 82052

Ankara, ?06100, Turkey (Türkiye)

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Teva Investigational Site 82051

Istanbul, 34098, Turkey (Türkiye)

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Teva Investigational Site 82049

Istanbul, 34250, Turkey (Türkiye)

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Teva Investigational Site 82050

Kocaeli, 41380, Turkey (Türkiye)

Location

Related Publications (1)

• Cutter G, Veneziano A, Grinspan A, Al-Banna M, Boyko A, Zakharova M, Maida E, Pasic MB, Gandhi SK, Everts R, Cordioli C, Rossi S. Higher satisfaction and adherence with glatiramer acetate 40 mg/mL TIW vs 20 mg/mL QD in RRMS. Mult Scler Relat Disord. 2019 Aug;33:13-21. doi: 10.1016/j.msard.2019.04.036. Epub 2019 May 9.

  PMID: 31132664 DERIVED

MeSH Terms

Conditions

Multiple Sclerosis

Interventions

Glatiramer Acetate

Condition Hierarchy (Ancestors)

Demyelinating Autoimmune Diseases, CNS; Autoimmune Diseases of the Nervous System; Nervous System Diseases; Demyelinating Diseases; Autoimmune Diseases; Immune System Diseases

Intervention Hierarchy (Ancestors)

Peptides; Amino Acids, Peptides, and Proteins

Limitations and Caveats

This study's 'interim' CSR covered the Core Period and used a cut-off date. The 'final' CSR covered the entire study. AE counts as reported here reflect the entire database and show minor differences from the interim CSR due to the cut-off date.

Results Point of Contact

• Title: Director, Clinical Research
• Organization: Teva Pharmaceutical Industries Ltd.

USMedInfo@tevapharm.com

+01 215-591-3000

Study Officials

• Teva Medical Expert, MD

  Teva Branded Pharmaceutical Products R&D, Inc.

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 1, 2015
• First Posted: July 16, 2015
• Study Start: August 10, 2015
• Primary Completion: January 10, 2017
• Study Completion: June 2, 2017
• Last Updated: December 9, 2021
• Results First Posted: August 20, 2018

Record last verified: 2021-12

Locations

AR (3); AU (1); FR (14); ME (4); DE (5); BE (2); PR (1); US (15); PL (12); RU (12); TU (4); CR (6); ES (7); FI (2); IE (1); IT (8)