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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

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

Status
Terminated
Phases
Phase 2
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT00831649
Enrollment
Unknown
Registered
2009-01-29
Start date
2004-09-30
Completion date
Unknown
Last updated
2016-06-16

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Rheumatoid Arthritis

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)

Interventions

DRUGnatalizumab

Sponsors

Elan Pharmaceuticals
CollaboratorINDUSTRY
Biogen
Lead SponsorINDUSTRY

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frame
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.—

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026