N/A
Completed N=110
Study to Evaluate the Safety, Tolerability and Efficacy of Tocilizumab in Participants With Rheumatoid Arthritis (RA) Who Have an Inadequate Response to Non-Biologic Disease Modifying Anti-rheumatic Drugs (DMARDs) and/or Anti-tumor Necrosis Factor (Anti-TNF) Therapy
Source: ClinicalTrials.gov NCT01362062 ↗Enrolled (actual)
110
Serious AEs
7.3%
Results posted
Apr 2016
Primary outcomePrimary: Percentage of Participants With Adverse Events (AEs) or Serious AEs (SAEs) — 31.8; 7.2 percentage of participants
Summary
This observational study will evaluate the safety, tolerability and efficacy of tocilizumab in participants with moderate to severe RA who have an inadequate response to current non-biologic DMARD and/or anti-TNF therapy. Data will be collected from each participant during tocilizumab therapy and on follow-up for a total of 12 months.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percentage of Participants With Adverse Events (AEs) or Serious AEs (SAEs) |
31.8; 7.2 | — |
| SECONDARY Percentage of Participants Achieving a Clinically Meaningful Improvement in Disease Activity Score 28 (DAS28) (Reduction of At Least 1.2 Units) at Every Visit |
55.3; 73.0; 81.1; 80.6; 84.6; 90.5 | — |
| SECONDARY Time Required to Achieve Clinically Meaningful Improvement in DAS28 (Reduction of At Least 1.2 Units) |
60 | — |
| SECONDARY Percentage of Participants Achieving Low Disease Activity (DAS28 Less Than [<] 3.2 Units) at Every Visit |
15.8; 27.0; 29.7; 44.4; 46.2; 42.9 | — |
| SECONDARY Time Required to Achieve Low Disease Activity (DAS28 <3.2 Units) |
117.25 | — |
| SECONDARY Percentage of Participants Achieving Remission (DAS28 <2.6 Units) at Every Visit |
5.3; 10.8; 16.2; 30.6; 35.9; 28.6 | — |
| SECONDARY Time Taken to Achieve Remission (DAS28 <2.6 Units) |
130.31 | — |
| SECONDARY Percentage of Participants Achieving American College of Rheumatology (ACR) 20, ACR50, ACR70 and ACR90 Responses at Every Visit |
86.3; 10.3; 0; 0; 75.8; 18.2 | — |
| SECONDARY Change From Baseline (CFB) in ESR Values at Every Visit |
-34.03; -39.63; -38.03; -38.71; -41.66; -39.07 | =0.001 sig |
| SECONDARY Change From Baseline in C-Reactive Protein (CRP) Levels at Every Visit |
-12.34; -12.82; -13.77; -12.15; -16.51; -13.92 | =0.003 sig |
| SECONDARY Participant's Global Assessment of Disease Activity Using VAS: Mean Change From Baseline at Every Visit |
-11.34; -18.67; -17.86; -24.51; -25.90; -27.20 | =0.002 sig |
| SECONDARY Physician's Global Assessment of Disease Activity Using VAS: Mean Change From Baseline at Every Visit |
-17.78; -23.56; -23.85; -29.06; -27.22; -29.00 | =0.001 sig |
| SECONDARY Participant's Assessment of Pain Using VAS: Mean Change From Baseline at Every Visit |
-13.66; -20.93; -21.14; -26.34; -29.32; -29.75 | =0.001 sig |
| SECONDARY Health Assessment Questionnaire Disability Index (HAQ-DI): Mean Change From Baseline at Every Visit |
-02.40; -02.21; -03.79; -03.85; -04.05; -03.92 | =0.064 |
Eligibility Criteria
Inclusion Criteria
- Moderate to severe active RA with an inadequate response to existing therapies (DMARDs and/or anti-TNFs)
- Considered eligible for tocilizumab therapy by the treating physician as per routine clinical practice
Exclusion Criteria
- Pregnant or breastfeeding females
- Immunization with live/attenuated vaccine within 4 weeks prior to baseline
- Participants with clinically significant raised liver enzyme, abnormal lipid profile, platelet count, hemoglobin, white blood cell and neutrophil count
- History of severe allergic or anaphylactic reactions to human, humanized or murine monoclonal antibodies
- Participants with active tuberculosis (TB). Participants with latent TB should be treated with standard anti-mycobacterial therapy before initiating tocilizumab and have a negative chest x ray for active TB at enrolment
- History of diverticulitis, chronic ulcerative lower GI disease such as Crohn's disease, ulcerative colitis or other symptomatic lower GI conditions that might predispose to perforations then the benefit risk ratio should be considered by treating physician
- Know active current or history of recurrent bacterial, viral, fungal, mycobacterial or other infection
- History of or currently active primary or secondary immunodeficiency or known human immunodeficiency virus (HIV) positive status
- Any other condition which puts the participant to undue risk for tocilizumab therapy as per local prescribing information or Investigator's judgement
Data sourced from ClinicalTrials.gov (NCT01362062). 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.