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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT00395317




Registration number
NCT00395317
Ethics application status
Date submitted
1/11/2006
Date registered
2/11/2006
Date last updated
9/04/2012

Titles & IDs
Public title
Study Of SB-683699 Compared To Placebo In Subjects With Relapsing-Remitting Multiple Sclerosis (MS)
Scientific title
Randomised, Double-blind, Placebo-controlled, Parallel-group, Dose-ranging Study to Investigate the MRI Efficacy and the Safety of Six Months Administration of SB-683699 in Subjects With Relapsing-Remitting Multiple Sclerosis
Secondary ID [1] 0 0
A4M105038
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Multiple Sclerosis 0 0
Condition category
Condition code

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Other interventions - Placebo
Treatment: Drugs - Firategrast 150 mg
Treatment: Drugs - Firategrast 300 mg

Placebo comparator: Arm 1 - placebo (4 tablets)

Experimental: Arm 2 - SB-683699 150 mg bid (1 x 150mg + 3 placebo tablets)

Experimental: Arm 3 - SB-683699 600 mg bid (2 x 300mg + 2 placebo tablets)

Experimental: Arm 4 - SB-683699 900 mg bid (3 x 300 mg + 1 placebo tablet)

Experimental: Arm 5 - SB-683699 1200 mg bid, male subjects only (4 x 300 mg tablets)


Other interventions: Placebo
placebo tablet

Treatment: Drugs: Firategrast 150 mg
150 mg tablet

Treatment: Drugs: Firategrast 300 mg
300 mg tablet
Intervention code [1] 0 0
Other interventions
Intervention code [2] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Cumulative number of new gadolinium-enhancing lesions on monthly MRI scans during the Treatment Phase
Timepoint [1] 0 0
Baseline and 24 weeks
Secondary outcome [1] 0 0
Cumulative volume of new gadolinium-enhancing lesions on monthly MRI scans
Timepoint [1] 0 0
Baseline and 24 weeks
Secondary outcome [2] 0 0
Cumulative number of persistent gadolinium-enhancing lesions on monthly MRI scans
Timepoint [2] 0 0
Baseline and 24 weeks
Secondary outcome [3] 0 0
Cumulative number of total enhancing lesions on monthly MRI scans: the sum of new and persistent gadolinium-enhancing lesions
Timepoint [3] 0 0
Baseline and 24 weeks
Secondary outcome [4] 0 0
Cumulative number of new T1 hypointense lesions on MRI scans
Timepoint [4] 0 0
Baseline and 24 weeks
Secondary outcome [5] 0 0
Cumulative number of new/newly enlarging T2 lesions on MRI scans
Timepoint [5] 0 0
Baseline and 24 weeks
Secondary outcome [6] 0 0
Relapses Occurring during the On-Treatment Phase
Timepoint [6] 0 0
Baseline and 24 weeks
Secondary outcome [7] 0 0
Change from Baseline in Expanded Disability Status Scale (EDSS) scores
Timepoint [7] 0 0
Baseline and 24 weeks
Secondary outcome [8] 0 0
Change from Baseline in Multiple Sclerosis Functional Composite (MSFC)scores
Timepoint [8] 0 0
Baseline and 24 weeks

Eligibility
Key inclusion criteria
Inclusion criteria:

* Written informed consent
* Males or females, aged 18 to 65, inclusive
* A diagnosis of relapsing-remitting MS [Polman, 2005; McDonald, 2001] with dissemination in time and space
* EDSS of between 0 and 6.0 inclusive at the Screening visit
* Occurrence of at least two relapses in previous 24 months with at least one relapse or documented evidence of gadolinium-enhancement on MRI (prior to screening) in the previous 12 months. Subject must not have had a relapse within 4 weeks prior to Screening. In addition, subjects experiencing a relapse between Screen and Visit 3 will not be eligible to be randomized.
* A minimum of five T2 lesions on brain MRI at Visit 2 as determined by the central MRI analysis reader
* A female subject is eligible to enter the study if she is:

* Of non-childbearing potential, i.e. women who:
* have documented evidence of tubal ligation, bilateral oophorectomy or hysterectomy; or
* are post-menopausal, defined as at least one year without menses in the absence of hormone replacement therapy. In questionable cases, menopausal status will be confirmed by oestradiol and FSH levels consistent with menopause according to local laboratory ranges. Oestrogen-containing hormone replacement therapies are not allowed during the study.
* Of childbearing potential, has a negative urine pregnancy test at Screening, and agrees to the consistent and correct use of one of the methods of contraception listed below. Subjects will use this contraceptive method for at least one month prior to Screening and should continue to use the same contraceptive method throughout the study until at least 3 days after the last dose of investigational product.
* Progesterone-only oral contraceptives or implants (inserted at least one month prior to Screening, but not beyond the third successive year following insertion). Oestrogen-containing contraceptives are not allowed during the study.
* Intra-uterine device (IUD) inserted by a qualified clinician. The IUD must have published data showing that the highest expected failure rate is less than 1% per year.
* Spermicide in conjunction with either a diaphragm, cervical cap or condom. Male partner sterilization (vasectomy) prior to female subject's entry into the study and is the sole partner for that female subject
* In France, a subject will be eligible for inclusion in this study only if either affiliated to or a beneficiary of a social security category.
Minimum age
18 Years
Maximum age
65 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
* Subjects receiving corticosteroids within 4 weeks of Screening for treatment of MS. If non-systemic steroids are being used for other chronic inflammatory conditions, subjects may be included at the discretion of the investigator after discussion with the GSK medical monitor
* Use of an b-interferon product, glatiramer acetate or azathioprine within 3 months of Screening, or use of Mitoxantrone within 12 months of Screening. Subjects who have received other therapies affecting the immune system (such as intravenous immunoglobulin (IVIg), cyclophosphamide, plasmapheresis, or any other immunosuppressive or immunomodulatory treatment) in the past may be included on a case by case basis after discussion with the GSK medical monitor. None of these treatments will be allowed during this study
* Previous exposure to alemtuzumab, natalizumab or firategrast administration, bone marrow transplantation or whole body irradiation
* Subjects with a cardiac pacemaker or any other type of metal implant or with any other contraindication for MRI (including known allergy to gadolinium)
* Use of 4-aminopyridine, rosiglitazone, pioglitazone or any drug that is an inhibitor of or a substrate (with a low therapeutic index) for OATP at Screening.
* Subjects with clinically significant renal laboratory values: subjects with a calculated creatinine clearance <60ml/min (by Cockcroft and Gault) at Screening
* Subjects with local urinalysis findings of 1) proteinuria, defined as =1+ protein, on urine dipstick or 2) renal tubular cell casts or 3) =5 red blood cells / high power field will be excluded from the study if the result is still present on a repeat urinalysis during the screening period.
* Presence of clinically significant hepatic laboratory values: ALT, AST, GGT > 2.0- times the upper limit of normal (ULN); total bilirubin > 1.5 times the ULN at Screening
* CD4 count <500, CD4:CD8 <1.0 (if result still present on a repeat test during the screening period), JC viremia detected in plasma or white cells, idiopathic CD4/CD8 lymphopenia or secondary lymphopenia at Screening
* Any findings on the MRI of the brain at Visit 2 other than MS, except for benign findings that (in the opinion of the central MRI reading site and local site investigator) require no further evaluation or treatment and do not impact patient's neurological health (e.g., small arachnoid cysts, venous angiomas)
* Current or history of cancer, excluding localized non-melanoma skin cancer
* Uncontrolled or any active bacterial, viral, or fungal infection at Screening. Any previous serious infections should be discussed with the GSK medical monitor (e.g. opportunistic or atypical infections)
* History of tuberculosis (TB) or positive chest X-ray for TB at Screening (prior chest X-ray is acceptable if performed within previous 6 months)
* Known congenital or acquired immunodeficiency
* Any abnormality on 12-lead ECG at Screening which is clinically significant in the opinion of the investigator
* Subjects with positive hepatitis B surface antigen, hepatitis C antibody, or HIV tests at Screening
* Women who are lactating, pregnant (positive pregnancy test at Screening), or planning to become pregnant during the course of the study
* Recent history or suspicion of current drug abuse (including analgesic abuse) or alcohol abuse within the last 6 months prior to Screening
* Use of an investigational drug for condition other than MS within 30 days or five half-lives (whichever is longer) preceding Screening. Prior use of an investigational drug for MS should be discussed with the GSK medical monitor
* Any concurrent illness, disability or clinically significant abnormality (including laboratory tests) that may affect the interpretation of clinical efficacy or safety data or prevent the subject from safely completing the assessments required by the protocol

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s

The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Phase 2
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
1/12/2006
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
1/08/2010
Sample size
Target
Accrual to date
Final
343
Recruitment in Australia
Recruitment state(s)
NSW,SA,VIC
Recruitment hospital [1] 0 0
GSK Investigational Site - Camperdown
Recruitment hospital [2] 0 0
GSK Investigational Site - Woodville
Recruitment hospital [3] 0 0
GSK Investigational Site - Fitzroy
Recruitment hospital [4] 0 0
GSK Investigational Site - Parkville
Recruitment postcode(s) [1] 0 0
2050 - Camperdown
Recruitment postcode(s) [2] 0 0
5011 - Woodville
Recruitment postcode(s) [3] 0 0
3065 - Fitzroy
Recruitment postcode(s) [4] 0 0
3050 - Parkville
Recruitment outside Australia
Country [1] 0 0
Austria
State/province [1] 0 0
Graz
Country [2] 0 0
Austria
State/province [2] 0 0
Innsbruck
Country [3] 0 0
Canada
State/province [3] 0 0
Ontario
Country [4] 0 0
Canada
State/province [4] 0 0
Quebec
Country [5] 0 0
Finland
State/province [5] 0 0
Turku
Country [6] 0 0
France
State/province [6] 0 0
Clermont Ferrand
Country [7] 0 0
France
State/province [7] 0 0
Dijon
Country [8] 0 0
France
State/province [8] 0 0
Lille
Country [9] 0 0
France
State/province [9] 0 0
Marseille
Country [10] 0 0
France
State/province [10] 0 0
Nantes
Country [11] 0 0
France
State/province [11] 0 0
Rennes Cedex 9
Country [12] 0 0
France
State/province [12] 0 0
Strasbourg
Country [13] 0 0
Germany
State/province [13] 0 0
Bayern
Country [14] 0 0
Germany
State/province [14] 0 0
Hessen
Country [15] 0 0
Germany
State/province [15] 0 0
Mecklenburg-Vorpommern
Country [16] 0 0
Germany
State/province [16] 0 0
Niedersachsen
Country [17] 0 0
Germany
State/province [17] 0 0
Nordrhein-Westfalen
Country [18] 0 0
Germany
State/province [18] 0 0
Sachsen
Country [19] 0 0
Germany
State/province [19] 0 0
Berlin
Country [20] 0 0
Germany
State/province [20] 0 0
Hamburg
Country [21] 0 0
Italy
State/province [21] 0 0
Abruzzo
Country [22] 0 0
Italy
State/province [22] 0 0
Lazio
Country [23] 0 0
Italy
State/province [23] 0 0
Lombardia
Country [24] 0 0
Italy
State/province [24] 0 0
Toscana
Country [25] 0 0
Netherlands
State/province [25] 0 0
Breda
Country [26] 0 0
Netherlands
State/province [26] 0 0
Den Bosch
Country [27] 0 0
Netherlands
State/province [27] 0 0
Eindhoven
Country [28] 0 0
Netherlands
State/province [28] 0 0
Nieuwegein
Country [29] 0 0
Netherlands
State/province [29] 0 0
Sittard-geleen
Country [30] 0 0
Netherlands
State/province [30] 0 0
Venray
Country [31] 0 0
New Zealand
State/province [31] 0 0
Auckland
Country [32] 0 0
New Zealand
State/province [32] 0 0
Christchurch
Country [33] 0 0
New Zealand
State/province [33] 0 0
Wellington
Country [34] 0 0
Norway
State/province [34] 0 0
Bergen
Country [35] 0 0
Norway
State/province [35] 0 0
Drammen
Country [36] 0 0
Norway
State/province [36] 0 0
Hamar
Country [37] 0 0
Norway
State/province [37] 0 0
Sandnes
Country [38] 0 0
Norway
State/province [38] 0 0
Skien
Country [39] 0 0
Poland
State/province [39] 0 0
Gdansk
Country [40] 0 0
Poland
State/province [40] 0 0
Poznan
Country [41] 0 0
Poland
State/province [41] 0 0
Warsaw
Country [42] 0 0
Russian Federation
State/province [42] 0 0
Moscow
Country [43] 0 0
Russian Federation
State/province [43] 0 0
St-Petersburg
Country [44] 0 0
Russian Federation
State/province [44] 0 0
St. Petersburg
Country [45] 0 0
Russian Federation
State/province [45] 0 0
St.-Petersburg
Country [46] 0 0
Spain
State/province [46] 0 0
Barakaldo (Vizcaya)
Country [47] 0 0
Spain
State/province [47] 0 0
Barcelona
Country [48] 0 0
Spain
State/province [48] 0 0
Madrid
Country [49] 0 0
Spain
State/province [49] 0 0
San Sebastián
Country [50] 0 0
Spain
State/province [50] 0 0
Sevilla
Country [51] 0 0
Spain
State/province [51] 0 0
Valencia
Country [52] 0 0
United Kingdom
State/province [52] 0 0
Essex
Country [53] 0 0
United Kingdom
State/province [53] 0 0
Hartshill, Stoke-on-Trent
Country [54] 0 0
United Kingdom
State/province [54] 0 0
Newcastle-Upon-Tyne
Country [55] 0 0
United Kingdom
State/province [55] 0 0
Nottingham
Country [56] 0 0
United Kingdom
State/province [56] 0 0
Sheffield

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
GlaxoSmithKline
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
GSK Clinical Trials
Address 0 0
GlaxoSmithKline
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

No documents have been uploaded by study researchers.

Results not provided in https://clinicaltrials.gov/study/NCT00395317