To Evaluate the Immunogenicity and Safety of Sarilumab Administered as Monotherapy in Patients With Rheumatoid Arthritis (RA)
Status: | Completed |
---|---|
Conditions: | Arthritis, Rheumatoid Arthritis |
Therapuetic Areas: | Rheumatology |
Healthy: | No |
Age Range: | 18 - Any |
Updated: | 4/21/2016 |
Start Date: | June 2014 |
End Date: | May 2015 |
An Open-label, Randomized, Parallel Group Study Assessing the Immunogenicity and Safety of Sarilumab Administered as Monotherapy in Patients With Active Rheumatoid Arthritis
Primary Objective:
To evaluate the immunogenicity of sarilumab administered as monotherapy.
Secondary Objectives:
- To evaluate the other safety aspects of sarilumab administered as monotherapy.
- To assess the exposure of sarilumab administered as monotherapy.
To evaluate the immunogenicity of sarilumab administered as monotherapy.
Secondary Objectives:
- To evaluate the other safety aspects of sarilumab administered as monotherapy.
- To assess the exposure of sarilumab administered as monotherapy.
Total study duration is up to 34 weeks: Up to 4-week screening period, 24-week open-label
treatment phase, 6-week post-treatment observation. After completion of the treatment phase
of this study, patients are eligible to enter a long term safety study (LTS11210 -
SARIL-RA-EXTEND) for continuous treatment with sarilumab (SAR153191 [REGN88]).
treatment phase, 6-week post-treatment observation. After completion of the treatment phase
of this study, patients are eligible to enter a long term safety study (LTS11210 -
SARIL-RA-EXTEND) for continuous treatment with sarilumab (SAR153191 [REGN88]).
Inclusion criteria:
- Diagnosis of rheumatoid arthritis (RA) ≥ 3 months.
- Moderately to severely active rheumatoid arthritis.
- Patients who per investigator judgment were incomplete responders to at least 12
weeks of an adequate dose of continuous treatment with or who were intolerant of one
or a combination of non-biologic disease modifying anti-rheumatic drugs (DMARDs).
Exclusion criteria:
- Patients < 18 years of age.
- Past history of, or current, autoimmune or inflammatory systemic or localized joint
disease(s) other than RA.
- History of juvenile idiopathic arthritis or arthritis onset prior to age 16.
- Severe active systemic RA, including but not limited to vasculitis, pulmonary
fibrosis, and/or Felty's syndrome.
- Prior treatment with any biologic anti-interleukin 6 (IL-6) or IL-6 receptor (IL-6R)
antagonist therapies.
- Treatment with prednisone > 10 mg or equivalent per day, or change in dosage within 4
weeks prior to randomization.
- New treatment with or dose-adjustment of on-going nonsteroidal anti-inflammatory drug
(NSAIDs) or cyclooxygenase-2 (COX-2) inhibitors within 4 weeks prior to
randomization, except for the use of low-dose acetylsalicylic acid for cardiovascular
diseases.
- Use of parenteral glucocorticoids or intraarticular glucocorticoids injection within
4 weeks prior to randomization.
- Prior treatment with a Janus kinase (JAK) inhibitor (tofacitinib).
- New treatment or dose-adjustment to on-going medication for dyslipidemia, such as
statin, within 6 weeks prior to randomization.
- Participation in any clinical research study evaluating another investigational drug
or therapy within 5 half-lives or 60 days of first dose of study drug administration,
whichever is longer.
- Patients with a history of malignancy other than adequately-treated carcinoma in-situ
of the cervix, nonmetastatic squamous cell or basal cell carcinoma of the skin,
within 5 years prior to the randomization visit. Nonmalignant lymphoproliferative
disorders are also excluded.
- Patients with active tuberculosis or untreated latent tuberculosis infection.
- Pregnant or breast feeding women.
The above information is not intended to contain all considerations relevant to a
patient's potential participation in a clinical trial.
We found this trial at
14
sites
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