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 2 study testing natalizumab in people with Rheumatoid Arthritis, run by Biogen.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Trial 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) Read more about this study

Who is it for?: Ages 18 to 75 years
Conditions the study is for: Rheumatoid Arthritis
What is being tested?: natalizumab
Could I receive a placebo?: No, everyone receives an active treatment
How many people: Not given
Where: No sites listed yet
Study dates: Sep 2004to Feb 2005
Phase: Phase 2
Are there results?: None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 to 75 years
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

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.

Who cannot join

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.

About this study

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)

Conditions: Rheumatoid Arthritis
Being tested: natalizumab
Medical subject headings: Arthritis, Rheumatoid

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

natalizumabDrug
Also called TYSABRI

Study groups in NCT00831649
Study group	Role	What they receive
natalizumab	Experimental	Not described Receives: Drug: natalizumab

What is being measured

The primary outcome is the main question the study is designed to answer.

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.

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Sep 2004Feb 2005

First posted29 Jan 2009 (estimated)
Study startSep 2004
Primary completionFeb 2005

Why it stopped: The biological effect seen with natalizumab was not sufficient to warrant further development in RA.

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Other trials for Rheumatoid ArthritisStudies of the same condition, open and under way.
More trials run by BiogenThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 2
Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)

IDs, dates and publications

ClinicalTrials.gov ID: NCT00831649
Sponsor's protocol ID: ELN100226-RA251
Status last verified: Jan 2009
First submitted: 27 Jan 2009
Last updated: 16 Jun 2016
Results posted: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

Official record

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All Rheumatoid Arthritis trials

Study at a glance

From the registry record, last updated by the sponsor on 16 Jun 2016. Recruitment status is as the sponsor reported it: confirm with the study team.

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
ClinicalTrials.gov ID: NCT00831649
Acronym / sponsor ID: ELN100226-RA251
Conditions: Rheumatoid Arthritis
Phase: Phase 2
Study type: Interventional
Recruitment status: TerminatedReason stopped: The biological effect seen with natalizumab was not sufficient to warrant further development in RA.
Lead sponsor: BiogenIndustry (pharma, biotech, devices)
Collaborators: Elan Pharmaceuticals
Study start: Sep 2004
Primary completion: Feb 2005 (actual)
First posted: 29 Jan 2009 (estimated)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

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)

Study design

Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Number of arms: 1

Arm	Type	Receives
natalizumab	Experimental	Drug: natalizumab

Who may qualify

Ages: 18 to 75 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (8 listed)

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;

Key exclusion criteria (8 listed)

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;

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
natalizumabAlso: TYSABRI	Drug	natalizumab

Primary outcome

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.

Results and safety

The study was stopped early (reason given: The biological effect seen with natalizumab was not sufficient to warrant further development in RA.). Results are not available in the source record.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 16 Jun 2016.

Related trials for Rheumatoid Arthritis

Not yet recruitingObservational study
The Impact of Rheumatoid Arthritis Treatments on the Modulation of Extracellular Vesicles and Other Biomarkers Involved in the Development of Lung Cancer
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Not yet recruiting
MYTP01 for Immune-Mediated Diseases
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Recruiting
EMPHASYS Cup Positioning in THA With Non-Invasive Navigation (Velys Hip Navigation (VHN))
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Active, not recruitingObservational study
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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

The record lists no contact. Use the official record to reach the sponsor.

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing natalizumab in people with Rheumatoid Arthritis, run by Biogen.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 8 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: stopped early, as of the sponsor's last update on 16 Jun 2016. Status can change between updates, so confirm with the study contact before making plans.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study was stopped early (reason given: The biological effect seen with natalizumab was not sufficient to warrant further development in RA.). Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

The number and proportion of subjects with AEs. The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00831649.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Jun 2016.