Phase 3
Completed N=218
A Long-Term Extension Study of WA22762 and NA25220 of Subcutaneous (SC) Tocilizumab (TCZ) in Moderate to Severe Rheumatoid Arthritis (RA)
Source: ClinicalTrials.gov NCT01662063 ↗Enrolled (actual)
218
Serious AEs
10.6%
Results posted
Oct 2016
Primary outcomePrimary: Number of Participants With at Least One Serious Adverse Event (SAE) — 4; 19 participants
◆ Published Evidence
Established
26citations · ~3 / year
Long-Term Safety and Efficacy of Subcutaneously Administered Tocilizumab for Adult Rheumatoid Arthritis: A Multicenter Phase 3b Long-term Extension Study.
Summary
This open-label extension study will evaluate the long-term safety and efficacy of SC TCZ in participants with moderate to severe RA who have completed the 97-week WA22762 (NCT01194414) or 96-week NA25220 (NCT01232569) core studies on SC or intravenous (IV) TCZ. Participants will receive TCZ 162 milligrams (mg) SC every week (QW) or every 2 weeks (Q2W) for up to 96 weeks.
Linked Publications
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Long-Term Safety and Efficacy of Subcutaneously Administered Tocilizumab for Adult Rheumatoid Arthritis: A Multicenter Phase 3b Long-term Extension Study.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Participants With at Least One Serious Adverse Event (SAE) |
4; 19 | — |
| PRIMARY Percentage of Participants With at Least One SAE |
9.1; 11.0 | — |
| PRIMARY Percentage of Participants With a Positive Anti-TCZ Antibody Assay at Any Timepoint |
4.5; 7.8 | — |
| PRIMARY Percentage of Participants With a Positive Anti-TCZ Antibody Assay at Baseline |
2.3; 4.8 | — |
| PRIMARY Percentage of Participants With a Positive Anti-TCZ Antibody Assay Post-Baseline |
2.3; 3.0; 0; 0.6; 0; 0.6 | — |
| SECONDARY Percentage of Participants Who Correctly Administered All SC TCZ Doses |
97.7; 97.7 | — |
| SECONDARY Disease Activity Score Based on 28 Joints (DAS28) Score |
4.55; 4.60; 3.17; 3.42; 3.08; 3.35 | — |
| SECONDARY Change From Baseline in DAS28 Score |
-1.38; -1.19; -1.42; -1.23; -1.51; -1.29 | — |
| SECONDARY Clinical Disease Activity Index (CDAI) Score |
20.10; 23.91; 13.99; 18.19; 14.86; 18.03 | — |
| SECONDARY Change From Baseline in CDAI Score |
-6.11; -5.81; -5.23; -5.47; -7.00; -6.63 | — |
| SECONDARY Simplified Disease Activity Index (SDAI) Score |
21.54; 25.10; 14.48; 18.32; 15.42; 18.18 | — |
| SECONDARY Change From Baseline in SDAI Score |
-7.07; -7.00; -5.71; -6.79; -7.99; -7.38 | — |
| SECONDARY Tender Joint Count (TJC) Score |
13.84; 19.14; 9.86; 14.06; 10.95; 13.86 | — |
| SECONDARY Change From Baseline in TJC Score |
-3.98; -5.17; -2.69; -5.12; -4.03; -5.60 | — |
| SECONDARY Swollen Joint Count (SJC) Score |
9.07; 10.83; 5.61; 7.87; 5.98; 8.57 | — |
| SECONDARY Change From Baseline in SJC Score |
-3.45; -3.00; -3.45; -2.31; -3.33; -3.89 | — |
| SECONDARY Number of Participants With a Disease-Modifying Anti-Rheumatic Drug (DMARD) Dose Reduction, Interruption, or Discontinuation |
3; 37; 1; 14; 1; 15 | — |
| SECONDARY Percentage of Participants With a DMARD Dose Reduction, Interruption, or Discontinuation |
7.3; 23.0; 2.4; 8.7; 2.4; 9.3 | — |
| SECONDARY Percentage of Reasons Given for DMARD Dose Reduction or Interruption |
0; 70.7; 0; 2.4; 0; 2.4 | — |
| SECONDARY Percentage of Reasons Given for DMARD Discontinuation |
66.7; 43.8; 33.3; 0; 0; 6.3 | — |
| SECONDARY Number of Participants With a Corticosteroid (CCS) Dose Reduction, Interruption, or Discontinuation |
6; 33; 5; 24; 0; 2 | — |
| SECONDARY Percentage of Participants With a CCS Dose Reduction, Interruption, or Discontinuation |
40.0; 37.1; 33.3; 27.0; 0; 2.2 | — |
| SECONDARY Percentage of Reasons Given for CCS Dose Reduction |
0; 3.6; 42.9; 0; 0; 2.4 | — |
| SECONDARY Percentage of Reasons Given for CCS Dose Interruption |
33.3; 66.7 | — |
| SECONDARY Percentage of Reasons Given for CCS Discontinuation |
0; 18.5; 50.0; 11.1; 0; 14.8 | — |
| SECONDARY Number of Participants Who Switched From the QW Regimen and Remained on the Q2W Regimen |
14 | — |
| SECONDARY Percentage of Participants Who Switched From the QW Regimen and Remained on the Q2W Regimen |
6.5 | — |
| SECONDARY Number of Participants Who Returned to the QW Regimen After Switching to the Q2W Regimen |
1; 1 | — |
| SECONDARY Time to Return to the QW Regimen After Switching to the Q2W Regimen |
20 | — |
| SECONDARY Global Assessment of Disease Activity by the Participant According to Visual Analog Scale (VAS) Score |
39.39; 47.25; 31.80; 37.84; 31.86; 37.51 | — |
| SECONDARY Change From Baseline in Global Assessment of Disease Activity by the Participant According to VAS Score |
-7.59; -9.59; -6.67; -9.67; -11.59; -10.14 | — |
| SECONDARY Global Assessment of Pain by the Participant According to VAS Score |
36.89; 45.42; 29.30; 33.27; 29.42; 34.48 | — |
| SECONDARY Change From Baseline in Global Assessment of Pain by the Participant According to VAS Score |
-7.59; -12.27; -6.63; -10.76; -10.62; -10.91 | — |
| SECONDARY Heath Assessment Questionnaire-Disability Index (HAQ-DI) Score |
0.98; 1.20; 0.95; 1.11; 0.94; 1.09 | — |
| SECONDARY Change From Baseline in HAQ-DI Score |
-0.02; -0.10; -0.01; -0.11; -0.08; -0.09 | — |
| SECONDARY Percentage of Participants With HAQ-DI Score <0.5 |
31.8; 17.9; 27.3; 20.9; 32.6; 23.4 | — |
| SECONDARY Number of Participants With Low Disease Activity According to DAS28, SDAI, and CDAI Criteria |
11; 46; 14; 43; 13; 41 | — |
| SECONDARY Percentage of Participants With Low Disease Activity According to DAS28, SDAI, and CDAI Criteria |
25.0; 26.7; 31.8; 25.3; 29.5; 23.7 | — |
| SECONDARY Number of Participants With Remission According to DAS28, SDAI, and Boolean Criteria |
6; 33; 2; 15; 1; 14 | — |
| SECONDARY Percentage of Participants With Remission According to DAS28, SDAI, and Boolean Criteria |
13.6; 19.2; 4.5; 8.8; 2.3; 8.1 | — |
Eligibility Criteria
Inclusion Criteria
- Completed the 97-week WA22762 (NCT01194414) or 96-week NA25220 (NCT01232569) core study on SC or IV TCZ and, based on the Investigator's judgment, may continue to benefit from TCZ treatment in this study investigating the SC formulation
- Receiving treatment on an outpatient basis
- Females of childbearing potential and males with female partners of childbearing potential must agree to use reliable means of contraception as defined by protocol
Exclusion Criteria
- Premature withdrawal from WA22762 (NCT01194414) or NA25220 (NCT01232569) core studies for any reason
- History of severe allergic or anaphylactic reactions to human, humanized, or murine monoclonal antibodies
- Evidence of serious uncontrolled concomitant disease or disorder
- Known active current or history of recurrent bacterial, viral, fungal, mycobacterial, or other infections
- Any major episode of infection requiring hospitalization or treatment with IV antibiotics within 4 weeks of Screening or oral antibiotics within 2 weeks of Screening
- History of or currently active primary or secondary immunodeficiency
- Oral corticosteroids at greater than (>) 10 mg per day prednisone or equivalent, or non-steroidal anti-inflammatory drugs (NSAIDs) above the maximum recommended dose
- Intra-articular or parenteral corticosteroids within 4 weeks prior to Baseline
- Treatment with any investigational or commercially available biologic disease-modifying anti-rheumatic drug (DMARD) other than TCZ at any time between completion of the core study WA22762 (NCT01194414) or NA25220 (NCT01232569) and enrollment in the long-term extension study
- Pregnant or breastfeeding women
- History of alcohol, drug, or chemical abuse within 1 year prior to Screening
Data sourced from ClinicalTrials.gov (NCT01662063) 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.