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Atacicept in Combination With Rituximab in Subjects With Rheumatoid Arthritis (August III)
This study is currently recruiting participants.
Verified by EMD Serono, May 2008
Sponsored by: EMD Serono
Information provided by: EMD Serono
ClinicalTrials.gov Identifier: NCT00664521
  Purpose

The primary objective of this study is to assess the safety and tolerability of combined treatment with atacicept and rituximab in subjects with active rheumatoid arthritis receiving re-treatment with rituximab.


Condition Intervention Phase
Rheumatoid Arthritis
Biological: Rituximab
Biological: Atacicept / placebo
Phase II

MedlinePlus related topics: Rheumatoid Arthritis
Drug Information available for: Rituximab
U.S. FDA Resources
Study Type: Interventional
Study Design: Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Parallel Assignment
Official Title: A Randomized, Double-Blind, Placebo Controlled, Multi-Centre, Exploratory, Pilot, Phase II Trial of 150mg Atacicept Given Subcutaneously in Combination With Rituximab in Subjects With Rheumatoid Arthritis.

Further study details as provided by EMD Serono:

Primary Outcome Measures:
  • Nature, incidence and severity of adverse events (AEs) [ Time Frame: Every 2 - 6 weeks ] [ Designated as safety issue: Yes ]
  • Proportion of subjects who develop IgG <3 g/L [ Time Frame: Every 2 - 6 weeks ] [ Designated as safety issue: Yes ]
  • Changes / abnormalities in vital signs/ routine safety lab parameters [ Time Frame: Every 2 - 6 weeks ] [ Designated as safety issue: Yes ]
  • Changes over time in vaccine immunization status [ Time Frame: Every 2 - 6 weeks ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • ACR and DAS28 composite scores at week 26 [ Time Frame: Every 2 - 6 weeks ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 54
Study Start Date: March 2008
Estimated Study Completion Date: November 2010
Estimated Primary Completion Date: September 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
1: Experimental Biological: Rituximab
Rituximab 1000 mg IV infusion, 2nd 1000 mg IV infusion given 2 weeks later, followed 28 days later by atacicept/placebo 150 mg/mL SC once weekly for 25 weeks
2: Experimental Biological: Atacicept / placebo
Atacicept/placebo 150 mg/mL SC once weekly for 25 weeks, given in combination with rituximab 1000 mg IV infusion on study day 10, 2nd 1000 mg IV infusion given 2 weeks later

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Male and female subjects
  • >18 years of age at the time of Informed Consent
  • who have rheumatoid arthritis (satisfying American College of Rheumatology criteria)
  • a disease history of at least 12 months.
  • Subjects must have active disease defined by

    • >8 swollen joints (out of 66)
    • >8 tender joints (out of 68)
    • CRP >6 mg/L
    • ESR >28 mm/h.
  • Subjects must have received previous treatment with rituximab and must be candidates for re-treatment with rituximab.
  • Female subjects of childbearing potential must be willing to avoid pregnancy by using an adequate method of contraception for 4 weeks before SD1, during the treatment period and for 12 months after the last dose of rituximab, and must have a negative urine pregnancy test at the screening visit and SD1.

Exclusion Criteria:

  • Neurological disease
  • Inflammatory joint disease other than rheumatoid arthritis
  • Any contraindication to rituximab as per national label
  • Use of disease-modifying anti-rheumatic drugs (DMARDs; including methotrexate) for less than 3 months or change in dosing regimen within 28 days before SD1, or methotrexate dose regimen >25 mg/week
  • Participation in any interventional clinical trial within 1 month before SD1 (or within 5 half-lives of the investigated compound before SD1, whichever is longer)
  • Prednisone dose regimen >10 mg/day (or equivalent), or change in steroid dosing regimen within 28 days before SD1
  • Active or latent tuberculosis within the year before screening or major infection requiring hospitalization or intravenous anti-infectives within 28 days before SD1
  • Serum IgG below 6 g/L
  • Known hypersensitivity to atacicept or to any of the components of the formulated atacicpet
  • Known hypersensitivity to rituximab, to any of the components of the formulated rituximab or to murine proteins
  • Breastfeeding or pregnancy
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00664521

Contacts
Contact: Carol Marsella, BSc (Hons) +41-22-414-3918 carol.marsella@merckserono.net
Contact: Amanda Clark, RGN, BN, BASc +41-22-414-3236 amanda.clark@merckserono.net

Locations
Finland
Research Site Recruiting
Helsinki, Finland
Contact: Local Medical Information     358-985-202-328        
Research Site Recruiting
Jyväskylä, Finland
Contact: Local Medical Information     358-985-202-328        
France
Research Site Recruiting
Paris, France
Contact: Local Medical Information     33-1476-12661        
Research Site Recruiting
Strasbourg, France
Contact: Local Medical Information     33-1476-12661        
Research Site Recruiting
Nice, France
Contact: Local Medical Information     33-1476-12661        
Netherlands
Research Site Recruiting
Amsterdam, Netherlands
Contact: Local Medical Information     317-030-25741        
Sweden
Research Site Recruiting
Stockholm, Sweden
Contact: Local Medical Information     468-562-44528        
Research Site Recruiting
Malmö, Sweden
Contact: Local Medical Information     468-562-44528        
United Kingdom
Research Site Recruiting
Norwich, United Kingdom
Contact: Local Medical Information     44-208-818-7232        
Research Site Recruiting
Newcastle, United Kingdom
Contact: Local Medical Information     44-208-818-7232        
Sponsors and Collaborators
EMD Serono
  More Information

Responsible Party: Merck Serono International S.A., an affiliate of Merck KGaA, Darmstadt, Germany ( Carol Marsella, Clinical Trial Leader )
Study ID Numbers: 28155
Study First Received: April 21, 2008
Last Updated: May 9, 2008
ClinicalTrials.gov Identifier: NCT00664521  
Health Authority: Finland: National Agency for Medicines;   France: Afssaps - French Health Products Safety Agency;   Netherlands: The Central Committee on Research Involving Human Subjects (CCMO);   Sweden: Medical Products Agency;   United Kingdom: Medicines and Healthcare Products Regulatory Agency

Study placed in the following topic categories:
Autoimmune Diseases
Musculoskeletal Diseases
Rituximab
Joint Diseases
Arthritis
Connective Tissue Diseases
Arthritis, Rheumatoid
Rheumatic Diseases

Additional relevant MeSH terms:
Immunologic Factors
Immune System Diseases
Antineoplastic Agents
Therapeutic Uses
Physiological Effects of Drugs
Antirheumatic Agents
Pharmacologic Actions

ClinicalTrials.gov processed this record on January 16, 2009