Please note the ANZCTR will be unattended from Friday 20 December 2024 for the holidays. The Registry will re-open on Tuesday 7 January 2025. Submissions and updates will not be processed during that time.

Registering a new trial?

To achieve prospective registration, we recommend submitting your trial for registration at the same time as ethics submission.

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this information for consumers
Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT00853762




Registration number
NCT00853762
Ethics application status
Date submitted
26/02/2009
Date registered
2/03/2009
Date last updated
20/03/2017

Titles & IDs
Public title
Atacicept in Multiple Sclerosis Extension Study, Phase II
Scientific title
An Open-label, Multicenter Phase II Extension of Study 28063 (ATAMS) to Obtain Long-term Follow-up Data in Subjects With Relapsing Multiple Sclerosis Treated With Atacicept for up to 5 Years (ATAMS-Extension)
Secondary ID [1] 0 0
28851
Universal Trial Number (UTN)
Trial acronym
ATAMS ext
Linked study record

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

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - Atacicept 25 mg
Treatment: Drugs - Atacicept 75 mg
Treatment: Drugs - Atacicept 150 mg
Treatment: Drugs - Atacicept 150 mg

Experimental: Atacicept 25 mg (With Loading) -

Experimental: Atacicept 75 mg (With Loading) -

Experimental: Atacicept 150 mg (With Loading) -

Experimental: Atacicept 150 mg (Without Loading) -


Treatment: Drugs: Atacicept 25 mg
Subjects who received atacicept 25 milligram (mg) subcutaneously (SC) as loading dose twice weekly for first 4 weeks, followed by atacicept 25 mg SC for 32 weeks, in 28063 study will continue with atacicept 25 mg SC once weekly up to 5 years or up to early termination of treatment or early termination of the study.

Treatment: Drugs: Atacicept 75 mg
Subjects who received atacicept 75 mg SC as loading dose twice weekly for first 4 weeks, followed by atacicept 75 mg SC for 32 weeks, in 28063 study will continued with atacicept 75 mg SC once weekly up to 5 years or up to early termination of treatment or early termination of the study.

Treatment: Drugs: Atacicept 150 mg
Subjects who received atacicept 150 mg SC as loading dose twice weekly for first 4 weeks, followed by atacicept 150 mg SC for 32 weeks, in 28063 study will continue with atacicept 150 mg SC once weekly up to 5 years or up to early termination of treatment or early termination of the study.

Treatment: Drugs: Atacicept 150 mg
Subjects who received placebo SC twice weekly for first 4 weeks, followed by placebo SC for 32 weeks, in 28063 study will continue with atacicept 150 mg (without loading dose) SC once weekly up to 5 years or up to early termination of treatment or early termination of the study.

Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Number of Subjects With Treatment Emergent Adverse Events (TEAEs), Serious TEAEs, Injection Site Reactions, Infections, and Malignancies by Severity
Timepoint [1] 0 0
From the first dose of study drug administration up to Week 24
Primary outcome [2] 0 0
Change From Baseline in Vital Signs: Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP)
Timepoint [2] 0 0
Baseline, Week 2, 4, 8, 12, 16, 20, 24 and 36
Primary outcome [3] 0 0
Change From Baseline in Vital Signs: Pulse Rate
Timepoint [3] 0 0
Baseline, Week 2, 4, 8, 12, 16, 20, 24 and 36
Primary outcome [4] 0 0
Change From Baseline in Vital Signs: Temperature
Timepoint [4] 0 0
Baseline, Week 2, 4, 8, 12, 16, 20, 24 and 36
Primary outcome [5] 0 0
Change From Baseline in Electrocardiogram (ECGs)
Timepoint [5] 0 0
Baseline, Week 12 and 36
Primary outcome [6] 0 0
Number of Subjects With Worsened Post Baseline Shift in Immunoglobulin A (IgA), IgG and IgM Levels
Timepoint [6] 0 0
Baseline up to Week 36
Primary outcome [7] 0 0
Number of Subjects With Positive Neutralizing Antibody (NAb)
Timepoint [7] 0 0
Baseline, Week 12 and 36
Secondary outcome [1] 0 0
Number of Subjects With Clinical Attacks/Relapses
Timepoint [1] 0 0
Baseline up to Week 24
Secondary outcome [2] 0 0
Change From Baseline in Expanded Disability Status Scale (EDSS) Scores at Week 12
Timepoint [2] 0 0
Baseline, Week 12
Secondary outcome [3] 0 0
Change in Multiple Sclerosis Functional Composite (MSFC) Score at Week 12
Timepoint [3] 0 0
Week 12
Secondary outcome [4] 0 0
Magnetic Resonance Imaging (MRI) Parameters: Number of T1 Gadolinium (Gd)-Enhancing Lesions Per Subject
Timepoint [4] 0 0
Baseline, Week 12 and 24
Secondary outcome [5] 0 0
Magnetic Resonance Imaging (MRI) Parameters: Volume of T2 Lesions (New or Enlarging T2 Lesions) Per Subject
Timepoint [5] 0 0
Baseline, Week 12 and Week 24
Secondary outcome [6] 0 0
Concentrations of Free and Total Atacicept
Timepoint [6] 0 0
Baseline and Week 12
Secondary outcome [7] 0 0
Free B-Lymphocyte Stimulator (BLyS) and Free A Proliferation-Inducing Ligand (APRIL) Serum Concentrations.
Timepoint [7] 0 0
Baseline, Week 12 and 36
Secondary outcome [8] 0 0
Pharmacogenetics/Pharmacogenomics Analysis
Timepoint [8] 0 0
Day 1 and Week 36

Eligibility
Key inclusion criteria
* Participation in study 28063.
* Completion of Week 36 visit of the core study 28063.
* Willingness and ability to comply with study procedures for the duration of the study.
* Voluntary provision of written informed consent (including, for the USA, subject authorization under the Health Insurance Portability and Accountability Act (HIPAA)), given before any study-related procedure that is not part of normal medical care and with the understanding that the subject may withdraw consent at any time without prejudice to his or her future medical care.
Minimum age
18 Years
Maximum age
60 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
* Premature discontinuation of core study 28063.
* Subjects who meet criteria listed below will receive IMP in study 28851:

* Subjects who are eligible for participation in extension study 28851 but do not meet these criteria will not be treated with IMP but will undergo scheduled visits, irrespective of their treatment.
* All subjects must satisfy the following criteria before Extension Study Day 1 (D1-EXT; defined as the first day of dosing in the extension study) to be eligible for treatment with IMP:

* Eligibility for participation in extension study 28851.
* For women of childbearing potential, a negative urine pregnancy test at eligibility assessment.
* Female subjects of childbearing potential must be willing to avoid pregnancy by using an adequate method of contraception for four (4) weeks before the first dose administered within the extension study, during the study and for twelve (12) weeks after the last dose of trial medication. Adequate contraception is defined as two barrier methods, or one barrier method with spermicide, or an intrauterine device, or use of a combined oral female hormonal contraceptive (or the definitions requested by health authorities and locally amended in the core study 28063). For the purposes of this trial, women of childbearing potential are defined as: "All female subjects after puberty unless they are post-menopausal for at least two years or are surgically sterile" (For Germany Only: Female subjects of childbearing potential must be willing to avoid pregnancy by using highly effective methods of contraception for approximately four (4) weeks prior to D1-EXT, during and for twelve (12) weeks after the last dose of trial medication. This requirement does not apply to surgically sterile subjects or to subjects who are postmenopausal for at least 2 years. Highly effective contraception is defined as any method or combination of methods which result in a low failure rate (i.e. less than (<) 1% per year) when used consistently and correctly, such as implants, injectables, combined oral contraceptives, sexual abstinence, vasectomized partner, 2 barrier methods, or 1 barrier method with spermicide)
* Willingness and ability to comply with study procedures for the duration of the study.
* To be eligible for treatment with investigational medicinal product (IMP) in study 28851, the subjects must not meet any of the following criteria:
* Non-eligibility for participation in extension study 28851 (premature discontinuation of core study 28063).
* Major protocol violation or non-compliance in the core study.
* Use of prohibited immunomodulatory / immunosuppressive therapies
* Serum immunoglobulin G (IgG) level <3 gram per liter (g/L) if the subject received atacicept in the core study, or serum IgG level <6 g/L if the subject received placebo in the core study (to protect the blinding of the core study, the IgG level will be communicated to the treating physician only if it is too low for extension study participation and only after all Week 36 assessments performed within the core study have been completed).
* Any condition, including laboratory findings that, in the opinion of the Investigator, constitutes a risk or a contraindication for participation in the extension study, or that could interfere with the study objectives, conduct or evaluation.
* Known active clinically significant acute or chronic infection, or any major episode of infection requiring hospitalization or treatment with parenteral anti-infectives.
* Investigator judgement that treatment of the subject with atacicept in the extension study is not appropriate.
* Aspartate aminotransferase (AST), or alanine aminotransferase (ALT), or alkaline phosphatase (AP) level greater than (>)2.5 x upper limit of normal (ULN), or total bilirubin >1.5 x ULN at eligibility assessment.
* Clinically significant abnormality in any hematological test (e.g. hemoglobin <100 g/L (6.21 millimoles per liter [mmol/L]), white blood cells <3 x 10^9 per liter (/L), platelets <100 x 10^9/L) at eligibility assessment.
* Clinically significant abnormality on electrocardiogram (ECG) performed at eligibility assessment.
* Presence of uncontrolled or New York Health Association (NYHA) class 3 or 4 congestive heart failure at Week 36 of the core study.
* Moderate to severe renal impairment (creatinine clearance <50 milliliter per minute (mL/min) according to Cockcroft-Gault equation).
* Allergy or hypersensitivity to gadolinium (Gd).
* Allergy or hypersensitivity to atacicept or to any of the components of the formulated atacicept.
* Diagnosis or family history of Creutzfeldt-Jakob disease (CJD).

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 assessing the outcomes
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
Stopped early
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
Recruitment hospital [1] 0 0
Research Site - Box Hill VIC
Recruitment hospital [2] 0 0
Research Site - Fitzroy
Recruitment hospital [3] 0 0
Research Site - New Lambton
Recruitment hospital [4] 0 0
Research Site - Woodville
Recruitment postcode(s) [1] 0 0
- Box Hill VIC
Recruitment postcode(s) [2] 0 0
- Fitzroy
Recruitment postcode(s) [3] 0 0
- New Lambton
Recruitment postcode(s) [4] 0 0
- Woodville
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
Arizona
Country [2] 0 0
United States of America
State/province [2] 0 0
Illinois
Country [3] 0 0
United States of America
State/province [3] 0 0
Michigan
Country [4] 0 0
United States of America
State/province [4] 0 0
Ohio
Country [5] 0 0
United States of America
State/province [5] 0 0
Pennsylvania
Country [6] 0 0
United States of America
State/province [6] 0 0
Tennessee
Country [7] 0 0
Belgium
State/province [7] 0 0
Diepenbeek
Country [8] 0 0
Belgium
State/province [8] 0 0
Sijsele
Country [9] 0 0
Canada
State/province [9] 0 0
Alberta
Country [10] 0 0
Canada
State/province [10] 0 0
Ontario
Country [11] 0 0
Czech Republic
State/province [11] 0 0
Brno
Country [12] 0 0
Czech Republic
State/province [12] 0 0
Hradec Králové
Country [13] 0 0
France
State/province [13] 0 0
Caen
Country [14] 0 0
France
State/province [14] 0 0
Saint-Herblain
Country [15] 0 0
Germany
State/province [15] 0 0
Bochum
Country [16] 0 0
Germany
State/province [16] 0 0
Düsseldorf
Country [17] 0 0
Lebanon
State/province [17] 0 0
Beyrouth
Country [18] 0 0
Lithuania
State/province [18] 0 0
Kaunas
Country [19] 0 0
Netherlands
State/province [19] 0 0
Breda
Country [20] 0 0
Netherlands
State/province [20] 0 0
Nieuwegein
Country [21] 0 0
Netherlands
State/province [21] 0 0
Rotterdam
Country [22] 0 0
New Caledonia
State/province [22] 0 0
Winston Salem
Country [23] 0 0
Russian Federation
State/province [23] 0 0
Ekaterinburg
Country [24] 0 0
Russian Federation
State/province [24] 0 0
Moscow
Country [25] 0 0
Russian Federation
State/province [25] 0 0
Novosibirsk
Country [26] 0 0
Russian Federation
State/province [26] 0 0
Saint Petersburg
Country [27] 0 0
Russian Federation
State/province [27] 0 0
Samara
Country [28] 0 0
Russian Federation
State/province [28] 0 0
Vladimir
Country [29] 0 0
Russian Federation
State/province [29] 0 0
Yaroslavl
Country [30] 0 0
Spain
State/province [30] 0 0
Barcelona
Country [31] 0 0
Spain
State/province [31] 0 0
Madrid
Country [32] 0 0
Spain
State/province [32] 0 0
Malaga
Country [33] 0 0
Sweden
State/province [33] 0 0
Stockholm
Country [34] 0 0
Switzerland
State/province [34] 0 0
Basel
Country [35] 0 0
Switzerland
State/province [35] 0 0
Innsbruck
Country [36] 0 0
Switzerland
State/province [36] 0 0
Zürich
Country [37] 0 0
Ukraine
State/province [37] 0 0
Kharkiv
Country [38] 0 0
Ukraine
State/province [38] 0 0
Kyiv
Country [39] 0 0
Ukraine
State/province [39] 0 0
Odessa
Country [40] 0 0
Ukraine
State/province [40] 0 0
Uzhgorod
Country [41] 0 0
United Kingdom
State/province [41] 0 0
London
Country [42] 0 0
United Kingdom
State/province [42] 0 0
Sheffield
Country [43] 0 0
United Kingdom
State/province [43] 0 0
Stoke on Trent

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
EMD Serono
Address
Country
Other collaborator category [1] 0 0
Commercial sector/industry
Name [1] 0 0
Merck KGaA, Darmstadt, Germany
Address [1] 0 0
Country [1] 0 0

Ethics approval
Ethics application status

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

Contacts
Principal investigator
Name 0 0
Daniel Mikol, MD, PhD
Address 0 0
EMD Serono
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.