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

CompletedPhase 2Relapsing MSNCT00207727

What it found

Met its main goal

The main measure showed a statistically significant benefit.

Measure	Estimate	95% CI	p
The Cumulative Number of Newly Gadolinium-enhancing T1-weighted Lesions on Cranial Magnetic Resonance Imaging (MRI)s Through Week 23.			0.00

Statistical analysis as posted on ClinicalTrials.gov.

What was tested

Treatment tested

Ustekinumab
Interleukin-12 inhibitor|Interleukin-23 inhibitor

Results by group

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

Week 23

Group	Value	Interval	Number analysed
Group I: Placebo	1.20 Lesions	0–9.6	49
Group II: Ustekinumab 27 mg Every 4 Weeks	1.00 Lesions	0–4	50
Group III: Ustekinumab 90 mg Every 8 Weeks	2.00 Lesions	0–12	50
Group IV: Ustekinumab 90 mg Every 4 Weeks	2.40 Lesions	0–7.2	50
Group V: Ustekinumab 180 mg Every 4 Weeks	2.00 Lesions	0–8	50

p = 0.00

Values as posted on ClinicalTrials.gov. Outcomes measured differently across trials are not directly comparable.

Safety

Group	Participants at risk	Serious adverse events
Group I: Placebo	49	1 (2.0%)
Group II: Ustekinumab 27 mg Every 4 Weeks	51	3 (5.9%)
Group III: Ustekinumab 90 mg Every 8 Weeks	47	0 (0.0%)
Group IV: Ustekinumab 90 mg Every 4 Weeks	52	2 (3.8%)
Group V: Ustekinumab 180 mg Every 4 Weeks	50	1 (2.0%)

As posted on ClinicalTrials.gov. Serious adverse events include any serious health event during the trial, whether or not the treatment caused it.

What it measured

Main measures

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

Other measures (2)

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

Who could take part

Relapsing MS · 18 to 65

Inclusion Criteria: * 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 Exclusion Criteria: * 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

As registered. Criteria can change, so ask the trial team or your neurologist.

About this trial

In the sponsor's words

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

Papers

Loading reviews and guidelines…

Related trials

LTS18002
Phase 3 · Not yet recruiting
Still running
FREXALT
Phase 3 · Running, not recruiting
Still running
LITMUS
Not a drug-phase study · Completed (inferred)
Results posted, no main test reported
Efficacy and Safety Study of Dapirolizumab pegol (BIIB133) in Participants with RMS
Phase 2 · Stopped early
Stopped early
SUSTAIN
Phase 3 · Stopped early
Stopped early
ZEUS
Not a drug-phase study · Stopped
Stopped early

History

Started
Jul 2004
Main results due
Mar 2006
Finished
Aug 2006
Results posted
Dec 2009

Assembled by software from public sources and not checked by people. Each record links to its source. Report an error