Multiple SclerosisPhase 2NCT00207727

A Safety and Efficacy Study of CNTO1275 in Patients With Multiple Sclerosis

A Phase 2 study testing CNTO 1275 in people with Multiple Sclerosis, run by Centocor, Inc..

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Trial summary

The purpose of the study is to evaluate the effectiveness and safety of CNTO 1275 in patients with Multiple Sclerosis Read more about this study

Who is it for?: Ages 18 to 65 years
Conditions the study is for: Multiple Sclerosis
What is being tested?: CNTO 1275
How many people: 249 participants
Where: No sites listed yet
Study dates: Jul 2004to Aug 2006
Phase: Phase 2
Are there results?: Yes, posted in the registrySummary in the doctors' view

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 65 years
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

Have a definite diagnosis of Relapsing remitting Multiple Sclerosis
Have a history of at least 1 of the following:a. A minimum of 2 relapses of MS within the previous 2 years but not within the 1-month period prior to screening. b. A relapse of MS within the previous 6 months but not within the 1-monthperiod prior to screening

Who cannot join

Have a CNS disease (eg, CNS lymphoma, systemic lupus erythematous)
Have significant bulbar involvement of MS or other neurologic deficits
Have a decubitus ulcer
Have received immunomodulatory therapies within 3 months of screening

About this study

Official title: A Phase II, Double-blind, Placebo-Controlled, Randomized, Dose-ranging Study of Multiple Subcutaneous Injections of Human Monoclonal Antibody to IL-12p40(CNTO1275) in Subjects With Relapsing-remitting Multiple Sclerosis

The purpose of the study is to evaluate the effectiveness and safety of CNTO 1275 in patients with Multiple Sclerosis

Read the detailed description

Multiple sclerosis (MS) is a life-long disease that usually starts in young adults. In MS, inflammation and damage to nerve cells occur in the brain and spinal cord. Symptoms of MS are quite variable and may range from being mild to severe and from short to long lasting. People with MS may have a wide variety of symptoms ranging from mild to disabling. Some of thesymptoms of MS include visual disturbances such as double vision, weakness in arms or legs,difficulty with coordination, fatigue, changes in sensations such as numbness and tingling, or difficulties with concentration or memory.The drug being tested in this research study is an antibody called CNTO 1275. Antibodies are natural substances made by the body that stick to and react with other substances in the body that may cause diseases. The body makes antibodies mainly to fight infections. CNTO 1275 is an antibody that has been manufactured in the laboratory. In the test tube, CNTO 1275 sticks to and blocks the activity of a naturally occurring substance in the body called interleukin 12 (IL-12).Higher than normal levels of IL-12 have been found in people who have MS. CNTO 1275 has been tested in animals with a condition similar to MS. In those animals, IL-12 was over-produced.Animals treated with CNTO 1275 showed decreased symptoms of the condition.The purpose of this study is to better understand the safety and effectiveness of CNTO 1275 in people who have relapsing-remitting MS

Patients will receive subcutaneous injections of 30, 100, 200 mg of CNTO 1275 or placebo at Weeks 0, 1, 2, 3, 7, 11, 15, and 19 or 100 mgs at weeks 0,1,2,3,11 and 19 and placebo at wks 7 and 15.

Conditions: Multiple Sclerosis
Being tested: CNTO 1275
Keywords: Multiple Sclerosis
Medical subject headings: Multiple Sclerosis

What participants receive

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

CNTO 1275Drug

What is being measured

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

The Cumulative Number of Newly Gadolinium-enhancing T1-weighted Lesions on Cranial Magnetic Resonance Imaging (MRI)s Through Week 23.
A newly Gadolinium (Gd) enhancing T1-weighted lesion is defined as a lesion that is enhanced on a current cranial MRI scan but was not classified as a newly Gd enhancing T1-weighted lesion on the previous MRI scan.
Measured: Week 23

Secondary outcomes (2)

Relapses of Multiple Sclerosis (MS) Through Week 23
Clinical relapse of MS is defined as any acute neurological event, reported by the patient, that is characterized by new or worsening signs or symptoms of MS lasting at least 48 hours after a stable period of at least 30 days that is considered, in the judgment of the study physician (treating neurologist), to be a clinical relapse of MS.
Measured: Week 23
Change From Baseline in Expanded Disability Status Scale (EDSS)
The EDSS is based on an independent neurologist's examination of 8 functional systems and is used to classify multiple sclerosis (MS) severity, progression, disability, and evaluate treatment results. A numeric score ranging from 0 (normal) to 10 (death) is produced, the change from baseline of the EDSS score ranges from -9 to 10.
Measured: Baseline, Week 23

Timeline

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

Jul 2004Aug 2006

First posted21 Sep 2005 (estimated)
Study startJul 2004
Primary completionMar 2006
Study completionAug 2006

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (2)Papers the sponsor has linked to this study.
Other trials for Multiple SclerosisStudies of the same condition, open and under way.
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: Randomised
Intervention model: Parallel groups
Masking: Double blind
Enrolment: 249 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT00207727
Sponsor's protocol ID: CR005284
Status last verified: Apr 2012
First submitted: 13 Sep 2005
Last updated: 23 Apr 2012
Results posted: Yes, on ClinicalTrials.gov

Publications

Robinson D Jr, Zhao N, Gathany T, Kim LL, Cella D, Revicki D. Health perceptions and clinical characteristics of relapsing-remitting multiple sclerosis patients: baseline data from an international clinical trial. Curr Med Res Opin. 2009 May;25(5):1121-30. doi: 10.1185/03007990902797675.
PubMed 19317608
Segal BM, Constantinescu CS, Raychaudhuri A, Kim L, Fidelus-Gort R, Kasper LH; Ustekinumab MS Investigators. Repeated subcutaneous injections of IL12/23 p40 neutralising antibody, ustekinumab, in patients with relapsing-remitting multiple sclerosis: a phase II, double-blind, placebo-controlled, randomised, dose-ranging study. Lancet Neurol. 2008 Sep;7(9):796-804. doi: 10.1016/S1474-4422(08)70173-X.
PubMed 18703004

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 Multiple Sclerosis trials

Study at a glance

From the registry record, last updated by the sponsor on 23 Apr 2012. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Phase II, Double-blind, Placebo-Controlled, Randomized, Dose-ranging Study of Multiple Subcutaneous Injections of Human Monoclonal Antibody to IL-12p40(CNTO1275) in Subjects With Relapsing-remitting Multiple Sclerosis
ClinicalTrials.gov ID: NCT00207727
Acronym / sponsor ID: CR005284
Conditions: Multiple Sclerosis
Keywords: Multiple Sclerosis
Phase: Phase 2
Study type: Interventional
Recruitment status: Completed
Enrolment: 249 participants (actual)
Lead sponsor: Centocor, Inc.Industry (pharma, biotech, devices)
Collaborators: Centocor BV
Study start: Jul 2004
Primary completion: Mar 2006 (actual)
Study completion: Aug 2006 (actual)
First posted: 21 Sep 2005 (estimated)
Results: Posted 2 Dec 2009

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 the study is to evaluate the effectiveness and safety of CNTO 1275 in patients with Multiple Sclerosis

Detailed description

Patients will receive subcutaneous injections of 30, 100, 200 mg of CNTO 1275 or placebo at Weeks 0, 1, 2, 3, 7, 11, 15, and 19 or 100 mgs at weeks 0,1,2,3,11 and 19 and placebo at wks 7 and 15.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Double blind

Who may qualify

Ages: 18 to 65 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (2 listed)

Have a definite diagnosis of Relapsing remitting Multiple Sclerosis
Have a history of at least 1 of the following:a. A minimum of 2 relapses of MS within the previous 2 years but not within the 1-month period prior to screening. b. A relapse of MS within the previous 6 months but not within the 1-monthperiod prior to screening

Key exclusion criteria (4 listed)

Have a CNS disease (eg, CNS lymphoma, systemic lupus erythematous)
Have significant bulbar involvement of MS or other neurologic deficits
Have a decubitus ulcer
Have received immunomodulatory therapies within 3 months of screening

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
CNTO 1275	Drug	–

Primary outcome

The Cumulative Number of Newly Gadolinium-enhancing T1-weighted Lesions on Cranial Magnetic Resonance Imaging (MRI)s Through Week 23.
Time frame: Week 23
A newly Gadolinium (Gd) enhancing T1-weighted lesion is defined as a lesion that is enhanced on a current cranial MRI scan but was not classified as a newly Gd enhancing T1-weighted lesion on the previous MRI scan.

2 secondary outcomes

Relapses of Multiple Sclerosis (MS) Through Week 23
Time frame: Week 23
Change From Baseline in Expanded Disability Status Scale (EDSS)
Time frame: Baseline, Week 23

Results and safety

Results posted to the registry on 2 Dec 2009, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Group I: Placebo	49	11
Group II: Ustekinumab 27 mg Every 4 Weeks	50	8
Group III: Ustekinumab 90 mg Every 8 Weeks	50	9
Group IV: Ustekinumab 90 mg Every 4 Weeks	50	13
Group V: Ustekinumab 180 mg Every 4 Weeks	50	16

Primary outcome: The Cumulative Number of Newly Gadolinium-enhancing T1-weighted Lesions on Cranial Magnetic Resonance Imaging (MRI)s Through Week 23.

Time frame: Week 23. Median (Inter-Quartile Range). Unit: Lesions

Measure	Group I: Placebo n = 49	Group II: Ustekinumab 27 mg Every 4 Weeks n = 50	Group III: Ustekinumab 90 mg Every 8 Weeks n = 50	Group IV: Ustekinumab 90 mg Every 4 Weeks n = 50	Group V: Ustekinumab 180 mg Every 4 Weeks n = 50
Value	1.20 (0.00 to 9.60)	1.00 (0.00 to 4.00)	2.00 (0.00 to 12.00)	2.40 (0.00 to 7.20)	2.00 (0.00 to 8.00)

Group I: Placebo vs Group II: Ustekinumab 27 mg Every 4 Weeks vs Group III: Ustekinumab 90 mg Every 8 Weeks vs Group IV: Ustekinumab 90 mg Every 4 Weeks vs Group V: Ustekinumab 180 mg Every 4 Weeks: p = 0.00, Jonckheere Terpstra

Population analysed: Intent to treat. Missing data was imputed. The average number of newly Gd enhancing T1-weighted lesions from all valid visits for the patient will be used when prohibited medications are initiated.

2 secondary outcomes are reported in the full results.

Adverse events

Time frame: 71 weeks. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Group I: Placebo	1 of 49 (2%)	31 of 49 (63.3%)	Not reported
Group II: Ustekinumab 27 mg Every 4 Weeks	3 of 51 (5.9%)	35 of 51 (68.6%)	Not reported
Group III: Ustekinumab 90 mg Every 8 Weeks	0 of 47 (0%)	34 of 47 (72.3%)	Not reported
Group IV: Ustekinumab 90 mg Every 4 Weeks	2 of 52 (3.8%)	38 of 52 (73.1%)	Not reported
Group V: Ustekinumab 180 mg Every 4 Weeks	1 of 50 (2%)	44 of 50 (88%)	Not reported

Limitations and caveats (from the sponsor): The count of patients with any nonserious adverse events (NAE) excludes patients who only had NAE that occurred in \<=5% of patients. This information may vary from existing approved labeling and publications due to the requirement of this website.

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 23 Apr 2012.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Derived from this study: PubMed 19317608Robinson D Jr, Zhao N, Gathany T, Kim LL, Cella D, Revicki D. Health perceptions and clinical characteristics of relapsing-remitting multiple sclerosis patients: baseline data from an international clinical trial. Curr Med Res Opin. 2009 May;25(5):1121-30. doi: 10.1185/03007990902797675.
Derived from this study: PubMed 18703004Segal BM, Constantinescu CS, Raychaudhuri A, Kim L, Fidelus-Gort R, Kasper LH; Ustekinumab MS Investigators. Repeated subcutaneous injections of IL12/23 p40 neutralising antibody, ustekinumab, in patients with relapsing-remitting multiple sclerosis: a phase II, double-blind, placebo-controlled, randomised, dose-ranging study. Lancet Neurol. 2008 Sep;7(9):796-804. doi: 10.1016/S1474-4422(08)70173-X.

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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.

Centocor, Inc. Clinical Trial study director

Centocor, Inc.

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing CNTO 1275 in people with Multiple Sclerosis, run by Centocor, Inc..

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 2 inclusion and 4 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: finished, as of the sponsor's last update on 23 Apr 2012. 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?

Yes. Results are posted in the registry (first posted 2 Dec 2009). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

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 Cumulative Number of Newly Gadolinium-enhancing T1-weighted Lesions on Cranial Magnetic Resonance Imaging (MRI)s Through Week 23. (time frame: Week 23). 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 NCT00207727, which also lists 2 linked publications.

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 23 Apr 2012; AzTrials last refreshed its copy on 8 Nov 2026.