# Efficacy and Safety of GSK3196165 Versus Placebo and Tofacitinib in Participants With Moderately to Severely Active Rheumatoid Arthritis Who Have an Inadequate Response to Conventional Synthetic (cs)/Biologic (b) Disease Modifying Anti-rheumatic Drugs (DMARDs)

> **NCT03970837** · PHASE3 · TERMINATED · sponsor: **GlaxoSmithKline** · enrollment: 1764 (actual)

## Conditions studied

- Arthritis, Rheumatoid

## Interventions

- **BIOLOGICAL:** GSK3196165 (Otilimab)
- **DRUG:** Tofacitinib
- **DRUG:** Placebo

## Key facts

- **NCT ID:** NCT03970837
- **Lead sponsor:** GlaxoSmithKline
- **Sponsor class:** INDUSTRY
- **Phase:** PHASE3
- **Study type:** INTERVENTIONAL
- **Status:** TERMINATED
- **Start date:** 2019-06-05
- **Primary completion:** 2021-10-29
- **Final completion:** 2023-01-18
- **Target enrollment:** 1764 (ACTUAL)
- **Why stopped:** Only Asia cohort is early terminated.Limited efficacy demonstrated in the contRAst program does not support a suitable benefit/risk profile for otilimab as a potential treatment for RA. GSK has decided not to progress with regulatory submissions.
- **Last updated:** 2023-11-30

## Collaborators

- [object Object]

## Primary source

ClinicalTrials.gov registry: https://clinicaltrials.gov/study/NCT03970837

## Citation

> US National Library of Medicine, ClinicalTrials.gov registration NCT03970837, "Efficacy and Safety of GSK3196165 Versus Placebo and Tofacitinib in Participants With Moderately to Severely Active Rheumatoid Arthritis Who Have an Inadequate Response to Conventional Synthetic (cs)/Biologic (b) Disease Modifying Anti-rheumatic Drugs (DMARDs)". Retrieved via AI Analytics 2026-06-25 from https://api.ai-analytics.org/clinical/NCT03970837. Licensed CC0.

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