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.
Study NCT00664521   Information provided by EMD Serono
First Received: April 21, 2008   Last Updated: March 21, 2009   History of Changes

April 21, 2008
March 21, 2009
March 2008
September 2010   (final data collection date for primary outcome measure)
  • 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 ]
  • Nature, incidence and severity of adverse events (AEs) [ Time Frame: Every 2 - 6 weeks ] [ Designated as safety issue: No ]
  • Proportion of subjects who develop IgG <3 g/L [ Time Frame: Every 2 - 6 weeks ] [ Designated as safety issue: No ]
  • Changes / abnormalities in vital signs/ routine safety lab parameters [ Time Frame: Every 2 - 6 weeks ] [ Designated as safety issue: No ]
  • Changes over time in vaccine immunization status [ Time Frame: Every 2 - 6 weeks ] [ Designated as safety issue: No ]
Complete list of historical versions of study NCT00664521 on ClinicalTrials.gov Archive Site
ACR and DAS28 composite scores at week 26 [ Time Frame: Every 2 - 6 weeks ] [ Designated as safety issue: Yes ]
ACR and DAS28 composite scores at week 26 [ Time Frame: Every 2 - 6 weeks ] [ Designated as safety issue: No ]
 
Atacicept in Combination With Rituximab in Subjects With Rheumatoid Arthritis
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.

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.

 
Phase II
Interventional
Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Parallel Assignment
Rheumatoid Arthritis
  • Biological: Rituximab
  • Biological: Atacicept / placebo
 
 

*   Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
 
Recruiting
54
November 2010
September 2010   (final data collection date for primary outcome measure)

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
Both
18 Years and older
No
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
Finland,   France,   Netherlands,   Sweden,   United Kingdom
 
NCT00664521
Carol Marsella, Clinical Trial Leader, Merck Serono International S.A., an affiliate of Merck KGaA, Darmstadt, Germany
28155
EMD Serono
 
 
EMD Serono
March 2009

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP