Phase 3
Completed N=132
To Evaluate the Immunogenicity and Safety of Sarilumab Administered as Monotherapy in Patients With Rheumatoid Arthritis (RA)
Source: ClinicalTrials.gov NCT02121210 ↗Enrolled (actual)
132
Serious AEs
2.3%
Results posted
Jun 2017
Primary outcomePrimary: Percentage of Participants With Incidence of Antidrug Antibodies (ADA) — 24.6; 18.2; 12.3; 6.1 Percentage of participants
◆ Published Evidence
Established
31citations · ~4 / year
Immunogenicity of Sarilumab Monotherapy in Patients with Rheumatoid Arthritis Who Were Inadequate Responders or Intolerant to Disease-Modifying Antirheumatic Drugs.
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.
Linked Publications
-
Immunogenicity of Sarilumab Monotherapy in Patients with Rheumatoid Arthritis Who Were Inadequate Responders or Intolerant to Disease-Modifying Antirheumatic Drugs.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percentage of Participants With Incidence of Antidrug Antibodies (ADA) |
24.6; 18.2; 12.3; 6.1; 10.8; 3.0 | — |
| SECONDARY Serum Sarilumab Concentration |
7350; 17200 | — |
Eligibility 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 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.
Data sourced from ClinicalTrials.gov (NCT02121210) and the linked publication. Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.