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Activity and Safety of Oral Administration of SSR150106XB for the Reduction of Inflammation in Patients With Active Rheumatoid Arthritis (ACCORD-RA)

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 evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT00545454
Recruitment Status : Completed
First Posted : October 17, 2007
Last Update Posted : August 8, 2017
Information provided by (Responsible Party):

Study Description
Brief Summary:

The primary objective of this study is to assess the reduction of systemic inflammation as measured by serum levels of C-reactive protein (CRP).

The secondary objectives are:

  • to assess the reduction of systemic inflammation as measured changes in acute phase protein, serum amyloid A (SAA) and cytokine interleukin-6 (IL-6), and clinical American College of Rheumatology response rate, and morning stiffness duration;
  • to assess the effect on pain relief within first 14 days;
  • to obtain evidence of the safety and tolerability of SSR150106;
  • to document trough plasma levels of SSR150106 and its first metabolite.

Condition or disease Intervention/treatment Phase
Rheumatoid Arthritis Drug: SSR150106 Drug: Placebos Phase 2

Study Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 79 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: Activity and Safety of Oral Administration of SSR150106XB for the Reduction of Inflammation in Patients With Active Rheumatoid Arthritis (RA): A 4-week, Multicenter, Randomized, Double-blind, Placebo-controlled Parallel Group Study of 90 µg Administered Once Daily and 90 µg Once Every Other Day
Study Start Date : October 2007
Primary Completion Date : June 2008
Study Completion Date : June 2008

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arms and Interventions

Arm Intervention/treatment
Experimental: SSR150106 QD
90 micro grams oral solution once daily (QD)
Drug: SSR150106
Experimental: SSR150106 OEQD
90 micro grams oral solution once every other day (OEQD)
Drug: SSR150106
Placebo Comparator: Placebo
oral solution QD or OEQD
Drug: Placebos

Outcome Measures

Primary Outcome Measures :
  1. Change from baseline in mean C-Reactive Protein level [ Time Frame: end of the 4-week double-blind treatment period ]

Secondary Outcome Measures :
  1. C-Reactive Protein, Serum Amyloid A and Cytokine Interleukin-6 levels [ Time Frame: at all time points measured ]
  2. Improvement responder rates based on the American College of Rheumatology criteria [ Time Frame: at all time points measured ]
  3. Pain relief (change from baseline) [ Time Frame: until day 14 ]
  4. Safety and tolerability [ Time Frame: During the entire study patient's participation ]
  5. Plasma levels of SSR150106 and its first metabolite [ Time Frame: On a weekly basis during treatment phase, except at the end of the 3rd week ]

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • Either treatment-naïve patients, or those who have discontinued their Rheumatoid Arthritis-directed medication due to intolerability or insufficient efficacy
  • At least 9 out of 68 tender joints; 6 out of 66 swollen joints; morning stiffness 45 min
  • C-Reactive Protein >=1.8 mg/dl confirmed during screening period
  • Non-poor Cytochrome P2D6 metabolizer status

Exclusion Criteria:

  • Functional Rheumatoid Arthritis class IV
  • Fever
  • Infections with hepatitis B, or C, or HIV
  • Presence or history (<5 years) of cancer
  • Manifest or latent tuberculosis
  • Functional abnormalities (including laboratory values) judged as clinically relevant

The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.

Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00545454

Sanofi-Aventis Administrative Office
Sofia, Bulgaria
Sanofi-Aventis Administrative Office
Zagreb, Croatia
Sanofi-Aventis Administrative Office
Praha, Czechia
Sanofi-Aventis Administrative Office
Bucuresti, Romania
Russian Federation
Sanofi-Aventis Administrative Office
Moscow, Russian Federation
Sanofi-Aventis Administrative Office
Bratislava, Slovakia
Sanofi-Aventis Administrative Office
Kiev, Ukraine
Sponsors and Collaborators
Principal Investigator: Karel PAVELKA, Prof., MD Karel PAVELKA
More Information

Additional Information:
Responsible Party: Sanofi
ClinicalTrials.gov Identifier: NCT00545454     History of Changes
Other Study ID Numbers: ACT5488
EudraCT 2007-00760-24
First Posted: October 17, 2007    Key Record Dates
Last Update Posted: August 8, 2017
Last Verified: August 2017

Keywords provided by Sanofi:

Additional relevant MeSH terms:
Arthritis, Rheumatoid
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases
Connective Tissue Diseases
Autoimmune Diseases
Immune System Diseases
Pathologic Processes