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A Phase II, Multicenter, Open-Label, Long-Term Study of the Safety, Tolerability, and Efficacy of Intravenous Natalizumab in Subjects With Rheumatoid Arthritis Who Have Previously Participated in Study ELN100226-RA201

Primary Purpose

Rheumatoid Arthritis

Status
Terminated
Phase
Phase 2
Locations
Study Type
Interventional
Intervention
natalizumab
Sponsored by
Biogen
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Rheumatoid Arthritis

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

INCLUSION CRITERIA

Subjects will be eligible to begin study participation if they meet all of the following inclusion criteria:

  • Subjects must give written informed consent
  • Male or female subjects ≥18 to ≤75 years of age (at randomization in Study ELN100226-RA201)
  • Subjects must have been randomized in Study ELN100226-RA201;
  • Subjects who have completed the Month 6 visit of Study ELN100226-RA201 OR Subjects who have an inadequate therapeutic response (defined as a < 20% reduction from baseline [Month 0 in Study ELN100226-RA201] for both painful/tender and swollen joint counts) after receiving at least 4 infusions of study drug and has not been rescued with other RA medications during the treatment phase of Study ELN100226-RA201;
  • Subjects must be taking MTX at the same dose last used in Study ELN100226-RA201;
  • Female subjects of childbearing potential agreed to use adequate, contraceptive methods (either intrauterine device [IUD], oral or depot contraceptive, or barrier plus spermicide). Female subjects of childbearing potential used adequate contraception for at least 2 months prior to study entry and continued contraception for at least 3 months after their last infusion of study drug;
  • Subjects must be willing and able to complete all planned study procedures.

EXCLUSION CRITERIA

Subjects will be excluded from the study if they meet any of the following exclusion criteria:

  • Females who are pregnant or breastfeeding or those planning to become pregnant in the next 14 months;
  • Subjects who have experienced anaphylaxis, angioedema, urticaria, clinical syndrome diagnostic of serum sickness, or biopsy-proven vasculitis to a previous infusion of study drug;
  • Subjects who received rescue intervention in Study ELN100226-RA201, defined as an increase in dose of an existing permitted concomitant treatment of RA or the introduction of a new treatment of RA;
  • Subject who are expected to be unavailable for the duration of the trial, likely to be noncompliant with the Protocol, or who are felt to be unsuitable by the Investigator for any other reason;
  • Subjects with a history of a malignancy (other than surgically excised basal or squamous cell carcinoma of the skin);
  • Subjects with a history of clinically significant and/or persistent gastrointestinal, pulmonary, chronic infection, cardiovascular, renal, hepatic, neurological, dermatological, immunological, major psychiatric (including drug or alcohol abusers) or hematological illness, which in the opinion of the Investigator places the subject at unacceptable risk for participation in the study;
  • Subjects who intend to donate blood or blood products during the period of the study or within one month following completion of the study.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm Type

    Experimental

    Arm Label

    natalizumab

    Arm Description

    Outcomes

    Primary Outcome Measures

    The number and proportion of subjects with AEs
    The number and proportion of subjects with SAEs
    The number and percentage of subjects who discontinue early from the study due to an AE
    Assessment of clinical laboratory parameters, physical examination, and vital signs.

    Secondary Outcome Measures

    Full Information

    First Posted
    January 27, 2009
    Last Updated
    June 14, 2016
    Sponsor
    Biogen
    Collaborators
    Elan Pharmaceuticals
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    1. Study Identification

    Unique Protocol Identification Number
    NCT00831649
    Brief Title
    A Phase II, Multicenter, Open-Label, Long-Term Study of the Safety, Tolerability, and Efficacy of Intravenous Natalizumab in Subjects With Rheumatoid Arthritis Who Have Previously Participated in Study ELN100226-RA201
    Official Title
    A Phase II, Multicenter, Open-Label, Long-Term Study of the Safety, Tolerability, and Efficacy of Intravenous Natalizumab in Subjects With Rheumatoid Arthritis Who Have Previously Participated in Study ELN100226-RA201
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    January 2009
    Overall Recruitment Status
    Terminated
    Why Stopped
    The biological effect seen with natalizumab was not sufficient to warrant further development in RA.
    Study Start Date
    September 2004 (undefined)
    Primary Completion Date
    February 2005 (Actual)
    Study Completion Date
    undefined (undefined)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    Biogen
    Collaborators
    Elan Pharmaceuticals

    4. Oversight

    5. Study Description

    Brief Summary
    The purpose of this study is to evaluate the long-term safety, tolerability, and efficacy of natalizumab in subjects with active rheumatoid arthritis (RA) receiving concomitant methotrexate (MTX)

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Rheumatoid Arthritis

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Phase 2
    Interventional Study Model
    Single Group Assignment
    Masking
    None (Open Label)
    Allocation
    N/A

    8. Arms, Groups, and Interventions

    Arm Title
    natalizumab
    Arm Type
    Experimental
    Intervention Type
    Drug
    Intervention Name(s)
    natalizumab
    Other Intervention Name(s)
    TYSABRI
    Primary Outcome Measure Information:
    Title
    The number and proportion of subjects with AEs
    Title
    The number and proportion of subjects with SAEs
    Title
    The number and percentage of subjects who discontinue early from the study due to an AE
    Title
    Assessment of clinical laboratory parameters, physical examination, and vital signs.

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Maximum Age & Unit of Time
    75 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    INCLUSION CRITERIA Subjects will be eligible to begin study participation if they meet all of the following inclusion criteria: Subjects must give written informed consent Male or female subjects ≥18 to ≤75 years of age (at randomization in Study ELN100226-RA201) Subjects must have been randomized in Study ELN100226-RA201; Subjects who have completed the Month 6 visit of Study ELN100226-RA201 OR Subjects who have an inadequate therapeutic response (defined as a < 20% reduction from baseline [Month 0 in Study ELN100226-RA201] for both painful/tender and swollen joint counts) after receiving at least 4 infusions of study drug and has not been rescued with other RA medications during the treatment phase of Study ELN100226-RA201; Subjects must be taking MTX at the same dose last used in Study ELN100226-RA201; Female subjects of childbearing potential agreed to use adequate, contraceptive methods (either intrauterine device [IUD], oral or depot contraceptive, or barrier plus spermicide). Female subjects of childbearing potential used adequate contraception for at least 2 months prior to study entry and continued contraception for at least 3 months after their last infusion of study drug; Subjects must be willing and able to complete all planned study procedures. EXCLUSION CRITERIA Subjects will be excluded from the study if they meet any of the following exclusion criteria: Females who are pregnant or breastfeeding or those planning to become pregnant in the next 14 months; Subjects who have experienced anaphylaxis, angioedema, urticaria, clinical syndrome diagnostic of serum sickness, or biopsy-proven vasculitis to a previous infusion of study drug; Subjects who received rescue intervention in Study ELN100226-RA201, defined as an increase in dose of an existing permitted concomitant treatment of RA or the introduction of a new treatment of RA; Subject who are expected to be unavailable for the duration of the trial, likely to be noncompliant with the Protocol, or who are felt to be unsuitable by the Investigator for any other reason; Subjects with a history of a malignancy (other than surgically excised basal or squamous cell carcinoma of the skin); Subjects with a history of clinically significant and/or persistent gastrointestinal, pulmonary, chronic infection, cardiovascular, renal, hepatic, neurological, dermatological, immunological, major psychiatric (including drug or alcohol abusers) or hematological illness, which in the opinion of the Investigator places the subject at unacceptable risk for participation in the study; Subjects who intend to donate blood or blood products during the period of the study or within one month following completion of the study.

    12. IPD Sharing Statement

    Learn more about this trial

    A Phase II, Multicenter, Open-Label, Long-Term Study of the Safety, Tolerability, and Efficacy of Intravenous Natalizumab in Subjects With Rheumatoid Arthritis Who Have Previously Participated in Study ELN100226-RA201

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