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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)

Primary Purpose

Rheumatoid Arthritis

Status

Completed

Phase

Phase 2

Locations

International

Study Type

Interventional

Intervention

SSR150106

Placebos

About this trial

This is an interventional treatment trial for Rheumatoid Arthritis focused on measuring Inflammation, anti-cytokine, anti-chemokine

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

Sanofi-Aventis Administrative Office
Sanofi-Aventis Administrative Office
Sanofi-Aventis Administrative Office
Sanofi-Aventis Administrative Office
Sanofi-Aventis Administrative Office
Sanofi-Aventis Administrative Office
Sanofi-Aventis Administrative Office

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Placebo Comparator

Arm Label

SSR150106 QD

SSR150106 OEQD

Placebo

Arm Description

90 micro grams oral solution once daily (QD)

90 micro grams oral solution once every other day (OEQD)

oral solution QD or OEQD

Outcomes

Primary Outcome Measures

Change from baseline in mean C-Reactive Protein level

Secondary Outcome Measures

C-Reactive Protein, Serum Amyloid A and Cytokine Interleukin-6 levels

Improvement responder rates based on the American College of Rheumatology criteria

Pain relief (change from baseline)

Safety and tolerability

Plasma levels of SSR150106 and its first metabolite

Full Information

NCT ID

NCT00545454

First Posted

October 16, 2007

Last Updated

August 4, 2017

Sponsor

Sanofi

1. Study Identification

Unique Protocol Identification Number

NCT00545454

Brief Title

Activity and Safety of Oral Administration of SSR150106XB for the Reduction of Inflammation in Patients With Active Rheumatoid Arthritis

Acronym

ACCORD-RA

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 Type

Interventional

2. Study Status

Record Verification Date

August 2017

Overall Recruitment Status

Completed

Study Start Date

October 2007 (undefined)

Primary Completion Date

June 2008 (Actual)

Study Completion Date

June 2008 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Sanofi

4. Oversight

Data Monitoring Committee

Yes

5. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Rheumatoid Arthritis

Keywords

Inflammation, anti-cytokine, anti-chemokine

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2

Interventional Study Model

Parallel Assignment

Masking

ParticipantInvestigator

Allocation

Randomized

Enrollment

79 (Actual)

8. Arms, Groups, and Interventions

Arm Title

SSR150106 QD

Arm Type

Experimental

Arm Description

90 micro grams oral solution once daily (QD)

Arm Title

SSR150106 OEQD

Arm Type

Experimental

Arm Description

90 micro grams oral solution once every other day (OEQD)

Arm Title

Placebo

Arm Type

Placebo Comparator

Arm Description

oral solution QD or OEQD

Intervention Type

Drug

Intervention Name(s)

SSR150106

Intervention Type

Drug

Intervention Name(s)

Placebos

Primary Outcome Measure Information:

Title

Change from baseline in mean C-Reactive Protein level

Time Frame

end of the 4-week double-blind treatment period

Secondary Outcome Measure Information:

Title

C-Reactive Protein, Serum Amyloid A and Cytokine Interleukin-6 levels

Time Frame

at all time points measured

Title

Improvement responder rates based on the American College of Rheumatology criteria

Time Frame

at all time points measured

Title

Pain relief (change from baseline)

Time Frame

until day 14

Title

Safety and tolerability

Time Frame

During the entire study patient's participation

Title

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

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

75 Years

Accepts Healthy Volunteers

Eligibility Criteria

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.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Karel PAVELKA, Prof., MD

Organizational Affiliation

Karel PAVELKA

Official's Role

Principal Investigator

Facility Information:

Facility Name