Evaluate Efficacy and Safety of Fingolimod 0.5 mg Orally Once Daily Versus Placebo in Chronic Inflammatory Demyelinating Polyradiculoneuropathy Patients.

NCT01625182 | Completed Phase 3 Results DMC FDA Drug

• 2 other identifiers: CFTY720I22012011-005280-24
• Study Type: interventional
• Target: 106
• Locations: 15 countries
• Sites: 67

Brief Summary

The study was designed to evaluate the efficacy and safety of fingolimod in the treatment of chronic inflammatory demyelinating polyradiculoneuropathy compared with placebo.

Conditions

Chronic Inflammatory Demyelinating Polyradiculoneuropathy

Keywords

chronic inflammatory demyelinating polyradiculoneuropathy, CIDP, FTY720, fingolimod.

Outcome Measures

Primary Outcomes (1)

• Time to First Confirmed Worsening on the Adjusted Inflammatory Neuropathy Cause and Treatment (INCAT) Disability Scale

  Confirmed worsening in CIDP was measured by the adjusted INCAT Disability Scale. The adjusted INCAT disability scale measures arm disability and leg disability. For arm disability the scale ranges from 0 (no upper limb problems) to 5 (inability to use either arm for any purposeful movement). The leg disability scale ranges from 0 (walking not affected) to 5 (restricted to wheelchair, unable to stand and walk a few steps with help). The total adjusted INCAT disability score is calculated by the sum of the arm and leg disability scores where the total score ranges from 0 to 10. A confirmed worsening was defined as an increase by 1 or more points on the adjusted INCAT disability scale from the value at baseline.

  Month 12

Secondary Outcomes (3)

• Change From Baseline for Grip Strength, Dominant Hand

  baseline, Month 6, Month 12

• Change From Baseline for Grip Strength, Non-dominant Hand

  baseline, Month 6, Month 12

• Change From Baseline for Rasch-Built Linearly Weighted Overall Disability Scale (R-ODS)

  baseline, Month 6, Month 12

Study Arms (2)

Fingolimod (FTY720)

EXPERIMENTAL

Participants received Fingolimod 0.5 mg orally once daily.

Drug: Fingolimod

Placebo

PLACEBO COMPARATOR

Participants received matching placebo to Fingolimod orally once daily.

Drug: Placebo Comparator

Interventions

Fingolimod DRUG

Fingolimod 0.5 mg capsules

Fingolimod (FTY720)

Placebo Comparator DRUG

Matching placebo capsules

Placebo

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• written informed consent must be obtained before any assessment is performed

You may not qualify if:

• disability defined by an INCAT Disability Scale score of 1-9 or, if INCAT score is 0, a documented history of disability sufficient to require treatment within the past 2 years following reduction or interruption of CIDP treatment
• receiving IVIg treatment (minimal dose equivalent to 0.4 g/kg every 4 weeks for a minimum of 12 weeks) or corticosteroids (minimal dose equivalent to prednisone 10 mg/day) treatment prior to the screening visit
• history of documented clinically meaningful deterioration confirmed by clinical examination during therapy or upon interruption or reduction of therapy within 18 months prior to Screening
• stable CIDP symptoms for the 6 weeks before randomization
• other chronic demyelinating neuropathies, including: Distal Acquired Demyelinating Symmetric Neuropathy (DADS) Multifocal Motor Neuropathy (MMN) pure sensory CIDP hematopoietic malignancy except for MGUS
• conditions in which the pathogenesis of the neuropathy may be different from CIDP such as: Lyme disease, POEMS syndrome, osteosclerotic myeloma, Castleman's disease
• treatment with plasma exchange within 2 months of randomization, immunosuppressive/chemotherapeutic medications: azathioprine, cyclophosphamide, cyclosporine, mycophenolate, etanercept, methotrexate tacrolimus or other immunosuppressive drugs within 6 months of randomization or 5 half-lives (whichever is later), Rituximab in the 2 years prior to randomization (patients that have received rituximab between 1 and 2 years should have B-cell levels within normal range), other cytotoxic immunosuppressive medications with sustained effects (including mitoxantrone, alemtuzumab, cladribine) at any time, hematopoietic stem cell transplantation at any time

Sponsors & Collaborators

• Novartis Pharmaceuticals: lead
• Tanabe Pharma Corporation: collaborator

Study Sites (67)

Novartis Investigative Site

Orange, California, 92868, United States

Location

Novartis Investigative Site

Miami, Florida, 33136, United States

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Novartis Investigative Site

St. Petersburg, Florida, 33713, United States

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Novartis Investigative Site

Chicago, Illinois, 60637, United States

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Novartis Investigative Site

Louisville, Kentucky, 40202, United States

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Novartis Investigative Site

Boston, Massachusetts, 02115, United States

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Novartis Investigative Site

New York, New York, 10032, United States

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Novartis Investigative Site

Patchogue, New York, 11772, United States

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Novartis Investigative Site

Plainview, New York, 11803, United States

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Novartis Investigative Site

Columbus, Ohio, 43210, United States

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Novartis Investigative Site

Houston, Texas, 77030, United States

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Novartis Investigative Site

Burlington, Vermont, 05401, United States

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Novartis Investigative Site

Sydney, New South Wales, 2050, Australia

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Novartis Investigative Site

Auchenflower, Queensland, 4066, Australia

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Novartis Investigative Site

Fitzroy, Victoria, 3065, Australia

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Novartis Investigative Site

Parkville, Victoria, 3050, Australia

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Novartis Investigative Site

Brussels, 1200, Belgium

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Novartis Investigative Site

Leuven, 3000, Belgium

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Novartis Investigative Site

Liège, 4000, Belgium

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Novartis Investigative Site

Kingston, Ontario, K7L 2V7, Canada

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Novartis Investigative Site

Québec, Quebec, G1J 1Z4, Canada

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Novartis Investigative Site

Greenfield Park, J4V 2J2, Canada

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Novartis Investigative Site

Montreal, H3A 2B4, Canada

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Novartis Investigative Site

Prague, 150 06, Czechia

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Novartis Investigative Site

Limoges, 87042, France

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Novartis Investigative Site

Marseille, 13385, France

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Novartis Investigative Site

Montpellier, 34295, France

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Novartis Investigative Site

Paris, 75013, France

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Novartis Investigative Site

Pessac, 33604, France

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Novartis Investigative Site

Strasbourg, 67091, France

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Novartis Investigative Site

Cologne, North Rhine-Westphalia, 50937, Germany

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Novartis Investigative Site

Bochum, 44791, Germany

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Novartis Investigative Site

Düsseldorf, 40225, Germany

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Novartis Investigative Site

Essen, 45147, Germany

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Novartis Investigative Site

Göttingen, 37075, Germany

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Novartis Investigative Site

Athens, GR 151 25, Greece

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Novartis Investigative Site

Thessaloniki, 546 36, Greece

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Novartis Investigative Site

Thessaloniki, 57010, Greece

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Novartis Investigative Site

Haifa, Israel

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Novartis Investigative Site

Ramat Gan, 52621, Israel

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Novartis Investigative Site

Tel Aviv, 64239, Israel

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Novartis Investigative Site

Legnano, MI, 20025, Italy

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Novartis Investigative Site

Rozzano, MI, 20089, Italy

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Novartis Investigative Site

Cefalù, PA, 90015, Italy

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Novartis Investigative Site

Ferrara, 44100, Italy

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Novartis Investigative Site

Milan, Italy

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Novartis Investigative Site

Pisa, 56126, Italy

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Novartis Investigative Site

Rome, 00168, Italy

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Novartis Investigative Site

Nagoya, Aichi-ken, 466-8560, Japan

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Novartis Investigative Site

Aomori, Aomori, 030-8553, Japan

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Novartis Investigative Site

Sayama, Osaka, 589-8511, Japan

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Novartis Investigative Site

Bunkyo, Tokyo, 113-8519, Japan

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Novartis Investigative Site

Kodaira, Tokyo, 187-8551, Japan

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Novartis Investigative Site

Chiba, 260-8677, Japan

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Novartis Investigative Site

Amsterdam, 1105 AZ, Netherlands

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Novartis Investigative Site

Maastricht, 5800, Netherlands

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Novartis Investigative Site

Gdansk, 80-803, Poland

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Novartis Investigative Site

Katowice, 40-662, Poland

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Novartis Investigative Site

Lodz, 93-121, Poland

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Novartis Investigative Site

Barcelona, Catalonia, 08025, Spain

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Novartis Investigative Site

L'Hospitalet de Llobregat, Catalonia, 08907, Spain

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Novartis Investigative Site

Madrid, 28040, Spain

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Novartis Investigative Site

Headington, Oxfordshire, OX3 9DU, United Kingdom

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Novartis Investigative Site

Glasgow, G51 4TF, United Kingdom

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Novartis Investigative Site

Liverpool, L9 7LJ, United Kingdom

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Novartis Investigative Site

London, WC1N 3BG, United Kingdom

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Novartis Investigative Site

Newcastle upon Tyne, NE1 4LP, United Kingdom

Location

Related Publications (1)

• Hughes R, Dalakas MC, Merkies I, Latov N, Leger JM, Nobile-Orazio E, Sobue G, Genge A, Cornblath D, Merschhemke M, Ervin CM, Agoropoulou C, Hartung HP; FORCIDP Trial Investigators. Oral fingolimod for chronic inflammatory demyelinating polyradiculoneuropathy (FORCIDP Trial): a double-blind, multicentre, randomised controlled trial. Lancet Neurol. 2018 Aug;17(8):689-698. doi: 10.1016/S1474-4422(18)30202-3. Epub 2018 Jul 9.

  PMID: 30001923 DERIVED

MeSH Terms

Conditions

Polyradiculoneuropathy, Chronic Inflammatory Demyelinating

Interventions

Fingolimod Hydrochloride

Condition Hierarchy (Ancestors)

Polyradiculoneuropathy; Autoimmune Diseases of the Nervous System; Nervous System Diseases; Demyelinating Diseases; Polyneuropathies; Peripheral Nervous System Diseases; Neuromuscular Diseases; Autoimmune Diseases; Immune System Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Sphingosine; Amino Alcohols; Alcohols; Organic Chemicals; Propylene Glycols; Glycols; Amines

Results Point of Contact

• Title: Study Director
• Organization: Novartis Pharmaceuticals

862-778-8300

Study Officials

• Novartis Pharmaceuticals

  Novartis Pharmaceuticals

  STUDY DIRECTOR

Publication Agreements

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

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 19, 2012
• First Posted: June 21, 2012
• Study Start: December 22, 2012
• Primary Completion: September 3, 2016
• Study Completion: September 3, 2016
• Last Updated: October 30, 2017
• Results First Posted: September 19, 2017

Record last verified: 2017-09

Locations

US (12); CA (4); GB (5); FR (6); PL (3); DE (5); IT (7); CZ (1); AU (4); BE (3); GR (3); JP (6); IL (3); NL (2); ES (3)