Clinical trial · Interventional
An Extension Study of Tocilizumab (Myeloma Receptor Antibody [MRA]) in Patients Completing Treatment in Tocilizumab Core Studies
Long-term Extension Study of Safety During Treatment With Tocilizumab (MRA) in Patients Completing Treatment in MRA Core Studies
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
This single-arm study evaluated the long-term efficacy and safety of tocilizumab in participants who had completed treatment in the tocilizumab core studies (NCT00106522 \[Roche protocol WA18062\], NCT00106574 \[Roche protocol WA18063\], and NCT00109408 \[Roche protocol WA17824\]) of adults with rheumatoid arthritis. Participants received tocilizumab alone or in combination with standard anti-rheumatic treatment.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Rheumatoid Arthritis | — | UNRESOLVED | — |
Interventions
Interventions (4)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Disease-modifying anti-rheumatic drugs | Drug | — | UNRESOLVED |
| Non-steroidal anti-inflammatory drugs | Drug | — | UNRESOLVED |
| Oral corticosteroids | Drug | — | UNRESOLVED |
| Tocilizumab | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Tocilizumab
- description
- Participants received tocilizumab 8 mg/kg intravenously every 4 weeks till the end of the study (up to 7 years, 7 months). In addition, participants may have also received disease-modifying anti-rheumatic drugs, non-steroidal anti-inflammatory drugs, and oral corticosteroids at the discretion of the investigator.
- interventionNames
- Drug: Tocilizumab
- Drug: Disease-modifying anti-rheumatic drugs
- Drug: Non-steroidal anti-inflammatory drugs
- Drug: Oral corticosteroids
Primary outcomes (1)
- measure
- Percentage of Participants With ≥ 1 Adverse Event
- timeFrame
- Baseline to the end of the study (up to 7 years, 7 months)
Secondary outcomes (15)
- measure
- Percentage of Participants Who Withdrew From Treatment
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Patients who have completed participation in 1 of the core studies in adult rheumatoid arthritis. Exclusion Criteria: * Treatment with any investigational agent since the last administration of study drug in the core studies. * Treatment with iv gamma globulin, plasmapheresis, or prosorba column since the last administration of study drug in the core studies. * Treatment with an anti-TNF or anti-IL1 agent, a T-cell co-stimulation modulator, or any biologic since the last administration of study drug in the core studies. * Immunization with a live/attenuated vaccine since the last administration of study drug in the core studies. * Previous treatment with any cell-depleting therapies, including investigational agents. * Parenteral, intramuscular, or intra-articular corticosteroids within 6 weeks prior to baseline in this study.
References
Publications (1)
- DERIVEDJones G, Wallace T, McIntosh MJ, Brockwell L, Gomez-Reino JJ, Sebba A. Five-year Efficacy and Safety of Tocilizumab Monotherapy in Patients with Rheumatoid Arthritis Who Were Methotrexate- and Biologic-naive or Free of Methotrexate for 6 Months: the AMBITION Study. J Rheumatol. 2017 Feb;44(2):142-146. doi: 10.3899/jrheum.160287. Epub 2016 Dec 1. PMID 27909081