A Phase 2, Double-blind, Placebo-controlled, Randomized, Dose-ranging Study of Multiple Subcutaneous Injections of Human Monoclonal Antibody to IL-12p40 (CNTO 1275) in Subjects with Relapsing-remitting Multiple Sclerosis.
- Conditions
- Relapse-remitting Multiple Sclerosis (RRMS)Classification code 10048393
- Registration Number
- EUCTR2004-000145-38-GB
- Lead Sponsor
- Centocor B.V.
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 0
1. Be >/= 18 and 2. Have a definite diagnosis of RRMS according to the 2001 Guidelines from the
International Panel on the Diagnosis of MS (McDonald at al, 2001).
3. Have a Kurtzke’s EDSS Scale score of 0 to 6.5 (described in Appendix B of the
protocol).
4. Have a history of at least 1 of the following:
* A minimum of 2 relapses of MS within the previous 2 years but not within the
1-month period prior to screening.
* A relapse of MS within the previous 6 months but not within the 1-month period
prior to screening.
5. Women of childbearing potential and men must be using adequate birth control
measures (eg, abstinence, oral contraceptives, intrauterine device [IUD], barrier
method with spermicide, or surgical sterilization) during the study and must agree
to continue such precautions for 1 year after receiving the last injection(s) of
study agent. Women of childbearing potential must test negative for pregnancy at
screening.
6. Are considered eligible according to county–specific TB screening guidelines for
latent TB defined in Section 4.3. of the protocol.
7. Are capable of providing written informed consent, which must be obtained prior
to any study-related procedures.
8. Are able to adhere to the study visit schedule and understand and comply with
other protocol requirements.
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range
1. Have a CNS disease (eg, CNS lymphoma, systemic lupus erythematous) that could
affect the interpretation of the functional disability scale scores.
2. Have significant bulbar involvement of MS or other neurologic deficits or history
that would, in the judgment of the investigator, place the subject at significant risk
of infectious complications.
3. Have a decubitus ulcer.
4. Have an indwelling foley catheter.
5. Have received any immunomodulating therapies (eg, interferon) within the
3-month period prior to screening.
6. Have received glatiramer acetate within the 3-month period prior to screening.
7. Have ever received cladribine or any chemotherapeutic agents (eg, mitoxantrone).
8. Have received systemic corticosteroids within the 1-month period prior to
screening.
9. Have received any previous treatment with CNTO 1275 or any other
investigational agent for the treatment of MS that is known to target IL-12 or
IL-23.
10. Have received treatment in a clinical study within 3 months prior to screening or
within 5 half-lives (if known) of an investigational agent, whichever is longer.
The Sponsor may grant inclusion approval on an individual basis if it is
determined unlikely that the investigational agent would have an effect on MRI
lesions during the screening or treatment period.
11. Are pregnant, nursing, or planning pregnancy (both men and women) within 1
year after the last study agent injection(s).
12. Have a history of a previous immediate hypersensitivity response including
anaphylaxis or a severe allergic reaction to monoclonal antibodies.
13. Have a chest x-ray at screening or within 2 months prior to screening that shows
evidence of malignancy, infection, or any abnormalities suggestive of TB as
described in Section 4.3.2. of the protocol.
14. Have laboratory evidence of any of the following:
* Hemoglobin < 8.0 gm/dL
* WBC count < 3.0 x 1,000,000,000 cells/L
* Neutrophil count < 1.5 x 1,000,000,000 cells/L
* Platelet count < 100 x 1,000,000,000 cells/L
* Serum transaminase levels > 1.5 times the upper limit of normal for the clinical
laboratory
* Serum creatinine levels > twice the upper limit of the normal reference
rangefor the clinical laboratory, unless calculated creatinine clearance is
> 30mL/min.
15. Have a serious infection (eg, hepatitis, pneumonia or pyelonephritis), a chronic
or serious recurring infection, hospitalization for infection, or treatment with IV
antibiotics for infection within 2 months prior to screening. Less serious
infections (eg, acute upper respiratory tract infection or uncomplicated urinary
tract infection) need not be considered exclusions at the discretion of the
investigator.
16. Have or have had opportunistic infections (eg, cytomegalovirus [CMV],
Pneumocystis carinii, histoplasmosis or any mycobacterial infection other than
TB) within 6 months prior to randomization.
17. Have a known or suspected diagnosis of asthma.
18. Have documented current or past infection with hepatitis B or C.
19. Have documented human immunodeficiency virus (HIV) infection.
20. Have presence of a transplanted organ (with the exception of a corneal
transplant performed > 3 months prior to randomization).
21. Have a known malignancy or history of malignancy within the previous 5 years
(with the exception of basal cell carci
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Main Objective: The primary objective of this study is to assess the dose-response effect of multiple subcutaneous (SC) injections of CNTO 1275 in subjects with RRMS based on the cumulative number of new gadolinium (Gd)-enhancing T1-weighted lesions on cranial MRIs through week 23.;Secondary Objective: The secondary objectives of this study are to assess the clinical response and safety of multiple SC injections of CNTO 1275 and to describe the pharmacokinetics after repeated doses of CNTO 1275 in subjects with RRMS.;Primary end point(s): The cumulative number of new Gd-enhancing T1-weighted lesions on cranial MRIs through week 23.
- Secondary Outcome Measures
Name Time Method