A Phase 1 interventional study of folic acid and methotrexate in Rheumatoid Arthritis, sponsored by Hoffmann-La Roche. Completed at 7 sites in 3 countries. Open to participants aged 18 Years to 75 Years. Per ClinicalTrials.gov, last updated 2016-11-02.
Sponsored by Hoffmann-La Roche · Phase 1, Interventional, and Treatment
This open-label randomized 2arm study will investigate the pharmacokinetics, pharmacodynamics, efficacy and safety of subcutaneously administered tocilizumab in patients with rheumatoid arthritis who have shown an inadequate response to methotrexate. Patients will be randomized to receive tocilizumab 162 mg sc either weekly or every other week, in combination with methotrexate, for 12 weeks. Assessments will be made at regular intervals during treatment and on the 3 weeks of follow-up.Target sample size is \< 50 individuals.
3,554 studies on the registry are indexed under Arthritis; 317 are open to participants now.
This study's enrollment of 29 is below the median of 90 across 2,377 interventional studies indexed under Arthritis.
Browse Arthritis studies →Hoffmann-La Roche is the lead sponsor of 2,061 studies on the registry; 85 are open to participants now.
Of its 319 completed or terminated interventional studies of FDA-regulated products, 239 (75%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Drug: folic acid · Drug: methotrexate · Drug: tocilizumab [RoActemra/Actemra]
Drug: folic acid · Drug: methotrexate · Drug: tocilizumab [RoActemra/Actemra]
\>/= 5 mg po weekly
7.5 - 25 mg weekly (oral or parenteral)
162 mg sc weekly (QW)for 12 weeks
162 mg sc every other week (Q2W) for 12 weeks
Pharmacokinetics of TCZ after QW or Q2W sc administration
Time frame: multiple sampling after 1st and last dose, weeks 1 and 12, at bi-weekly intervals during treatment and twice on follow-up
Pharmacodynamic responses of CRP
Time frame: sampling in weeks 1 and 2 and at weekly or bi-weekly intervals throughout treatment
Safety and tolerability, including injection site reaction
Time frame: laboratory assessments every 2nd week on treatment and after 3 weeks follow-up, injection site evaluation after 1st, 2nd and last injection.
Efficacy according to ACR and DAS-EULAR parameters
Time frame: assessments on day 1 of weeks 1, 4, 8 and 12
PD responses of IL-6, sIL-6R and anti TCZ antibody
Time frame: multiple sampling after 1st and last dose, weeks 1 and 12, at bi-weekly intervals during treatment and twice on follow-up
This study is completed, as verified in Nov 2016. You cannot join it, but the record below documents what was studied.
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Hoffmann-La Roche