Full Text View
Tabular View
No Study Results Posted
Related Studies
Atacicept in Combination With Rituximab in Subjects With Rheumatoid Arthritis (August III)
This study is currently recruiting participants.
Verified by EMD Serono, March 2009
First Received: April 21, 2008   Last Updated: March 21, 2009   History of Changes
Sponsor: 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

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.

Resource links provided by NLM:


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

No publications provided

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: March 21, 2009
ClinicalTrials.gov Identifier: NCT00664521     History of Changes
Health Authority: Finland: Finnish Medicines Agency;   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

Additional relevant MeSH terms:
Autoimmune Diseases
Immune System Diseases
Immunologic Factors
Antineoplastic Agents
Rituximab
Joint Diseases
Physiological Effects of Drugs
Arthritis, Rheumatoid
Rheumatic Diseases
Pharmacologic Actions
Musculoskeletal Diseases
Therapeutic Uses
Arthritis
Connective Tissue Diseases
Antirheumatic Agents

ClinicalTrials.gov processed this record on November 30, 2009