To Evaluate the Immunogenicity and Safety of Sarilumab Administered as Monotherapy in Patients With Rheumatoid Arthritis (RA) (SARIL-RA-ONE)
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| ClinicalTrials.gov Identifier: NCT02121210 |
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Recruitment Status :
Completed
First Posted : April 23, 2014
Results First Posted : June 20, 2017
Last Update Posted : June 20, 2017
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Sponsor:
Sanofi
Collaborator:
Regeneron Pharmaceuticals
Information provided by (Responsible Party):
Sanofi
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Brief Summary:
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.
| Condition or disease | Intervention/treatment | Phase |
|---|---|---|
| Rheumatoid Arthritis | Drug: sarilumab SAR153191 (REGN88) | Phase 3 |
Total study duration was 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, participants were eligible to enter a long term safety study (LTS11210 - SARIL-RA-EXTEND) for continuous treatment with sarilumab (SAR153191 [REGN88]).
| Study Type : | Interventional (Clinical Trial) |
| Actual Enrollment : | 132 participants |
| Allocation: | Randomized |
| Intervention Model: | Parallel Assignment |
| Masking: | None (Open Label) |
| Primary Purpose: | Treatment |
| Official Title: | An Open-label, Randomized, Parallel Group Study Assessing the Immunogenicity and Safety of Sarilumab Administered as Monotherapy in Patients With Active Rheumatoid Arthritis |
| Study Start Date : | June 2014 |
| Actual Primary Completion Date : | May 2015 |
| Actual Study Completion Date : | May 2015 |
Resource links provided by the National Library of Medicine
MedlinePlus Genetics related topics:
Rheumatoid arthritis
Drug Information available for:
Sarilumab
| Arm | Intervention/treatment |
|---|---|
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Experimental: Sarilumab 150 mg q2w
Sarilumab 150 mg subcutaneous (SC) injection every two weeks (q2w) for 24 weeks.
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Drug: sarilumab SAR153191 (REGN88)
Pharmaceutical form: Solution for injection; Route of administration: Subcutaneous |
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Experimental: Sarilumab 200 mg q2w
Sarilumab 200 mg SC injection q2w for 24 weeks.
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Drug: sarilumab SAR153191 (REGN88)
Pharmaceutical form: Solution for injection; Route of administration: Subcutaneous |
Primary Outcome Measures :
- Percentage of Participants With Incidence of Antidrug Antibodies (ADA) [ Time Frame: From Baseline to Week 30 [End of study (EOS)] ]ADA to sarilumab and anti-sarilumab neutralizing antibodies in serum samples were determined using a validated electrochemiluminescence immunoassay method. Percentage of participants with positive ADA during treatment emergent adverse event (TEAE) period (time from first dose of investigational medicinal product [IMP] to last dose of IMP + 60 days) was determined. Persistent ADA Response: treatment-emergent ADA detected at 2 or more consecutive sampling time points during the TEAE period, where the first and last ADA positive samples were separated by a period of at least 16 weeks or if the last measured sample was positive. ADA samples were collected prior to IMP administration at Week 0 (baseline), Week 2, 4, 12, 24 and 30.
Secondary Outcome Measures :
- Serum Sarilumab Concentration [ Time Frame: Pre-dose at Week 0 (Baseline), 2, 4, 12, 16, 20, 24 and 30 ]Trough Concentration (Ctrough).
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| Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion criteria:
- Diagnosis of rheumatoid arthritis (RA) ≥ 3 months.
- Moderately to severely active rheumatoid arthritis.
- Participants 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:
- Participants < 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 intra-articular 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.
- Participants with a history of malignancy other than adequately-treated carcinoma in-situ of the cervix, non-metastatic squamous cell or basal cell carcinoma of the skin, within 5 years prior to the randomization visit. Non-malignant lymphoproliferative disorders are also excluded.
- Participants 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 Participant's potential participation in a clinical trial.
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): NCT02121210
Locations
Show 28 study locations
Sponsors and Collaborators
Sanofi
Regeneron Pharmaceuticals
Investigators
| Study Director: | Clinical Sciences & Operations | Sanofi |
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
| Responsible Party: | Sanofi |
| ClinicalTrials.gov Identifier: | NCT02121210 |
| Other Study ID Numbers: |
EFC13752 2013-002790-22 U1111-1143-4344 ( Other Identifier: UTN ) |
| First Posted: | April 23, 2014 Key Record Dates |
| Results First Posted: | June 20, 2017 |
| Last Update Posted: | June 20, 2017 |
| Last Verified: | May 2017 |
Additional relevant MeSH terms:
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Arthritis Arthritis, Rheumatoid Joint Diseases Musculoskeletal Diseases |
Rheumatic Diseases Connective Tissue Diseases Autoimmune Diseases Immune System Diseases |