Phase 3
Completed N=1,820
Long-term Safety and Efficacy of Sirukumab in Participants With RA Completing Studies CNTO136ARA3002 or CNTO136ARA3003
Arthritis, Rheumatoid
Source: ClinicalTrials.gov NCT01856309 ↗
Enrolled (actual)
1,820
Serious AEs
24.7%
Results posted
May 2019
Primary outcomePrimary: Percentage of Participants With Serious Adverse Events (SAEs) — 21.3; 27.8; 26.4; 23.1 Percentage of participants
◆ Published Evidence
Emerging
18citations · ~4 / year
Long-term safety and efficacy of sirukumab for patients with rheumatoid arthritis who previously received sirukumab in randomised controlled trials (SIRROUND-LTE).
Summary
The purpose of this study is to evaluate the long-term safety and efficacy of CNTO 136 (sirukumab) in participants with rheumatoid arthritis (RA) who are unresponsive to treatment with modifying antirheumatic drugs (DMARDs) or anti-TNF alpha agents.
Linked Publications
-
Long-term safety and efficacy of sirukumab for patients with rheumatoid arthritis who previously received sirukumab in randomised controlled trials (SIRROUND-LTE).
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percentage of Participants With Serious Adverse Events (SAEs) |
21.3; 27.8; 26.4; 23.1 | — |
| PRIMARY Percentage of Participants With Major Adverse Cardiovascular Events (MACE) |
2.0; 0.7; 2.3; 1.1 | — |
| PRIMARY Percentage of Participants With Malignancies |
1.0; 3.4; 1.5; 1.8 | — |
| PRIMARY Percentage of Participants With Serious Infections |
7.9; 12.0; 10.4; 10.7 | — |
| PRIMARY Percentage of Participants With Gastrointestinal (GI) Perforations |
0.7; 1.4; 0.7; 0.5 | — |
| PRIMARY Percentage of Participants With Hepatobiliary Abnormalities |
0; 0.3; 0.2; 0.2 | — |
| PRIMARY Percentage of Participants With Serious or Moderate/Severe Systemic Hypersensitivity Reactions, or Serum Sickness Adverse Events |
0.3; 0.7; 0.2; 0.3 | — |
| SECONDARY Percentage of Participants With Toxicity Grade 4 Decrease in Neutrophils |
1.3; 0; 0.5; 0 | — |
| SECONDARY Percentage of Participants With Toxicity Grade 4 Decrease in Platelets |
0; 0; 0; 0 | — |
| SECONDARY Percentage of Participants With ALT >= 3*ULN, ALT >= 5*ULN and ALT >= 8*ULN |
14.1; 14.4; 15.9; 17.1; 2.0; 2.4 | — |
| SECONDARY Percentage of Participants With AST >= 3*ULN, AST >= 5*ULN and AST >= 8*ULN |
3.9; 6.2; 4.5; 7.8; 0.3; 1.7 | — |
| SECONDARY Percentage of Participants With Either ALT >= 3*ULN or AST >= 3*ULN, and Total Bilirubin >= 2*ULN |
0; 0; 0; 0.2 | — |
| SECONDARY Percentage of Participants With Normal Total Cholesterol Value at Baseline and at Least 1 Abnormal Value Post-Baseline |
86.4; 81.6; 82.5; 87.2 | — |
| SECONDARY Percentage of Participants With Normal Low-Density Lipoprotein (LDL) Value at Baseline and at Least 1 Abnormal Value Post-Baseline |
70.2; 67.9; 69.7; 70.8 | — |
| SECONDARY Percentage of Participants With Normal High-Density Lipoprotein (HDL) Value at Baseline and at Least 1 Abnormal Value Post-Baseline |
16.2; 14.7; 16.1; 16.0 | — |
| SECONDARY Percentage of Participants With Normal Triglyceride Value at Baseline and at Least 1 Abnormal Value Post-Baseline |
32.6; 35.1; 36.1; 34.4 | — |
| SECONDARY Percentage of Participants Who Achieved American College of Rheumatology (ACR) 50 Response Through Week 260 |
2.5; 2.4; 9.1; 9.7; 16.2; 14.6 | — |
| SECONDARY Percentage of Participants With Boolean-Based American College of Rheumatology (ACR) or European League Against Rheumatism (EULAR) Remission Through Week 260 |
0.2; 0.2; 0.5; 0.6; 0.8; 1.5 | — |
| SECONDARY Percentage of Participants With Disease Activity Index Score 28 (CRP) Remission Through Week 260 |
2.7; 2.6; 7.5; 9.0; 10.2; 13.4 | — |
| SECONDARY Change From Baseline in Clinical Disease Activity Index (CDAI) Score Through Week 260 |
-6.54; -6.10; -11.09; -10.73; -13.79; -14.05 | — |
| SECONDARY Percentage of Participants With Simplified Disease Activity Index Based (SDAI-based) American College of Rheumatology (ACR)/ European League Against Rheumatism (EULAR) Remission Through Week 260 |
0.2; 0.2; 0.8; 1.1; 1.2; 2.9 | — |
| SECONDARY Change From Baseline in Health Assessment Questionnaire-Disability Index (HAQ-DI) Score Through Week 260 |
-0.1136; -0.1230; -0.2307; -0.2417; -0.3112; -0.3683 | — |
| SECONDARY Percentage of Participants With Health Assessment Questionnaire-Disability Index (HAQ-DI) Response Through Week 260 |
36.3; 36.4; 48.3; 51.3; 56.4; 57.6 | — |
Eligibility Criteria
Inclusion Criteria
- Completed participation in Studies CNTO136ARA3002 or CNTO136ARA3003
- Signed an informed consent form (ICF) indicating that they understand the purpose of and procedures required for the study and are willing to participate in the study
- Signed an informed consent form (ICF) for pharmacogenetics research (how a person's genes may affect a drug's effects) in order to participate in the optional pharmacogenetics component of this study. Refusal to give consent for this component does not exclude a participant from participation in this clinical study
Exclusion Criteria
- Withdraws consent and/or discontinues participation in study CNTO136ARA3002 or CNTO136ARA3003
- Is pregnant
- Has active diverticulitis
- Has any condition that, in the opinion of the investigator, would make participation not be in the best interest (eg, compromise the well-being) of the participant or that could prevent, limit, or confound the protocol-specified assessments
Data sourced from ClinicalTrials.gov (NCT01856309) 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.