Trial reportAnnals of the rheumatic diseases2016
Tocilizumab in early progressive rheumatoid arthritis: FUNCTION, a randomised controlled trial.
Trial report in Annals of the rheumatic diseases, 2016. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT01007435 (A Multi-center, Randomized, Double-blind, Parallel Group Study of the Safety, Disease Remission and Prevention of Structural Joint Damage During Treatment With Tocilizumab), which is not on this map. Cited by 97 papers, 14 of them syntheses that pooled it.
What it found
Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.
The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.
The trial behind it
Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
A Multi-center, Randomized, Double-blind, Parallel Group Study of the Safety, Disease Remission and Prevention of Structural Joint Damage During Treatment With Tocilizumab (TCZ), as a Monotherapy and in Combination With Methotrexate (MTX), Versus Methotrexate in Patients With Early, Moderate to Severe Rheumatoid Arthritis
Who cites it
97 citing papers in PubMed, 14 syntheses or guidelines pooled it, 194 citations in OpenAlex.
- Comparative safety of interleukin inhibitors for rheumatoid arthritis: a systematic review and network meta-analysis of randomized controlled trials.Frontiers in immunology · 2026Pooled it
- Efficacy and safety of non-conventional synthetic disease-modifying antirheumatic drugs in early active rheumatoid arthritis: a network meta-analysis.BMC rheumatology · 2025Pooled it
- Efficacy and safety of Tocilizumab for thyroid eye disease: a systemic review and Meta-analysis.Journal of endocrinological investigation · 2025Pooled it
- Remission definitions guiding immunosuppressive therapy in rheumatoid arthritis: which is best fitted for the purpose?RMD open · 2024Pooled it
- Pooled it
- 2021 American College of Rheumatology Guideline for the Treatment of Rheumatoid Arthritis.Arthritis care & research · 2021Guideline
- Efficacy of methotrexate in reducing the risk of bone erosion in patients with rheumatoid arthritis: a systematic review of randomized controlled trials.Osteoporosis international : a journal established as result of cooperation between the European Foundation for Osteoporosis and the National Osteoporosis Foundation of the USA · 2021Pooled it
- Radiographic progression in clinical trials in rheumatoid arthritis: a systemic literature review of trials performed by industry.RMD open · 2020Pooled it
- Efficacy of pharmacological treatment in rheumatoid arthritis: a systematic literature research informing the 2019 update of the EULAR recommendations for management of rheumatoid arthritis.Annals of the rheumatic diseases · 2020Pooled it
- Comparative Effectiveness of Combining MTX with Biologic Drug Therapy Versus Either MTX or Biologics Alone for Early Rheumatoid Arthritis in Adults: a Systematic Review and Network Meta-analysis.Journal of general internal medicine · 2019Pooled it
- Effectiveness of Remission Induction Strategies for Early Rheumatoid Arthritis: a Systematic Literature Review.Current rheumatology reports · 2019Pooled it
- Intensive therapy and remissions in rheumatoid arthritis: a systematic review.BMC musculoskeletal disorders · 2018Pooled it
- Efficacy of Monotherapy with Biologics and JAK Inhibitors for the Treatment of Rheumatoid Arthritis: A Systematic Review.Advances in therapy · 2018Pooled it
- [S2e guideline: treatment of rheumatoid arthritis with disease-modifying drugs].Zeitschrift fur Rheumatologie · 2018Guideline
- Effectiveness and safety over 3 years after the 2-year U-Act-Early trial of the strategies initiating tocilizumab and/or methotrexate.Rheumatology (Oxford, England) · 2020Trial
- Subcutaneous tocilizumab in rheumatoid arthritis: findings from the common-framework phase 4 study programme TOZURA conducted in 22 countries.Rheumatology (Oxford, England) · 2018Trial
- Patient-reported outcomes of baricitinib in patients with rheumatoid arthritis and no or limited prior disease-modifying antirheumatic drug treatment.Arthritis research & therapy · 2017Trial
- Identification of differential co-expressed gene networks in early rheumatoid arthritis achieving sustained drug-free remission after treatment with a tocilizumab-based or methotrexate-based strategy.Arthritis research & therapy · 2017Trial
- Tocilizumab combination therapy or monotherapy or methotrexate monotherapy in methotrexate-naive patients with early rheumatoid arthritis: 2-year clinical and radiographic results from the randomised, placebo-controlled FUNCTION trial.Annals of the rheumatic diseases · 2017Trial
- Baricitinib, Methotrexate, or Combination in Patients With Rheumatoid Arthritis and No or Limited Prior Disease-Modifying Antirheumatic Drug Treatment.Arthritis & rheumatology (Hoboken, N.J.) · 2017Trial
37 more citing papers are in PubMed but not listed here.
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
8 authors at 6 institutions in 5 countries.
Funding
Abstract
objectivesThe efficacy of tocilizumab (TCZ), an anti-interleukin-6 receptor antibody, has not previously been evaluated in a population consisting exclusively of patients with early rheumatoid arthritis (RA).
methodsIn a double-blind randomised controlled trial (FUNCTION), 1162 methotrexate (MTX)-naive patients with early progressive RA were randomly assigned (1:1:1:1) to one of four treatment groups: 4 mg/kg TCZ+MTX, 8 mg/kg TCZ+MTX, 8 mg/kg TCZ+placebo and placebo+MTX (comparator group). The primary outcome was remission according to Disease Activity Score using 28 joints (DAS28-erythrocyte sedimentation rate (ESR) <2.6) at week 24. Radiographic and physical function outcomes were also evaluated. We report results through week 52.
resultsThe intent-to-treat population included 1157 patients. Significantly more patients receiving 8 mg/kg TCZ+MTX and 8 mg/kg TCZ+placebo than receiving placebo+MTX achieved DAS28-ESR remission at week 24 (45% and 39% vs 15%; p<0.0001). The 8 mg/kg TCZ+MTX group also achieved significantly greater improvement in radiographic disease progression and physical function at week 52 than did patients treated with placebo+MTX (mean change from baseline in van der Heijde-modified total Sharp score, 0.08 vs 1.14 (p=0.0001); mean reduction in Health Assessment Disability Index, -0.81 vs -0.64 (p=0.0024)). In addition, the 8 mg/kg TCZ+placebo and 4 mg/kg TCZ+MTX groups demonstrated clinical efficacy that was at least as effective as MTX for these key secondary endpoints. Serious adverse events were similar among treatment groups. Adverse events resulting in premature withdrawal occurred in 20% of patients in the 8 mg/kg TCZ+MTX group.
conclusionsTCZ is effective in combination with MTX and as monotherapy for the treatment of patients with early RA. TRIAL REGISTRATION NUMBER: ClinicalTrials.gov, number NCT01007435.
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Registered trials
Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.