NCT02319642 (RAPID-C OLE) is a Phase 3 clinical trial of Certolizumab Pegol in Rheumatoid Arthritis, sponsored by UCB Pharma SA.

Who is sponsoring NCT02319642?

NCT02319642 is sponsored by UCB Pharma SA.

What drugs are being tested in NCT02319642?

Interventions in NCT02319642: Certolizumab Pegol.

What condition does NCT02319642 study?

NCT02319642 studies Rheumatoid Arthritis.

Is NCT02319642 still recruiting?

NCT02319642 is currently completed. Last updated 15 October 2018.

Are results published for NCT02319642?

Yes — primary outcome results have been posted to ClinicalTrials.gov. See the outcomes section above for details.

Last reviewed 2018-10-15 · How we verify

NCT02319642: RAPID-C OLE

Name: Drug Landscape Pharmaceutical Database
Creator: Drug Landscape
Published: 2026-01-01
License: https://creativecommons.org/licenses/by/4.0/

A Phase 3, Multicenter, Open-label Extension Study To Assess The Safety And Efficacy Of Certolizumab Pegol As Additional Medication To Methotrexate In Chinese Subjects With Active Rheumatoid Arthritis Who Participated In RA0044.

Completed Phase 3 Results posted Last updated 15 October 2018

What this trial tests

Phase 3 trial testing Certolizumab Pegol in Rheumatoid Arthritis in 347 participants. Completed in 1 December 2016.

Timeline

1 November 2014

Primary endpoint
1 December 2016

1 December 2016

Quick facts

Lead sponsor	UCB Pharma SA
Phase	Phase 3
Status	Completed
Study type	INTERVENTIONAL
Allocation	na
Design	single group
Masking	none
Primary purpose	treatment
Enrollment	347
Start date	1 November 2014
Primary completion	1 December 2016
Estimated completion	1 December 2016
Sites	30 locations across China

Drugs / interventions tested

Certolizumab Pegol (CERTOLIZUMAB PEGOL) — full drug profile →

Conditions studied

Rheumatoid Arthritis — all drugs for Rheumatoid Arthritis →

Sponsor

UCB Pharma SA — full company profile →

Who can join

18 and older, any sex, with Rheumatoid Arthritis. Patients with the condition only — healthy volunteers not accepted.

What's being measured

Primary outcomes are the specific endpoints the trial is designed to prove or disprove.

Percentage of Subjects That Withdrew Due to a Treatment-emergent Adverse Event (TEAE)
Time frame: Baseline to the end of observation period (32 weeks)
TEAEs are defined as Advere Events (AEs) starting on or after the date of first study medication administration in this Open-label Extension (OLE) study up to 70 days post-last dose.
Percentage of Subjects With at Least One Treatment-emergent Adverse Event (TEAE)
Time frame: Baseline to the end of observation period (32 weeks)
TEAEs are defined as Adverse Events (AEs) starting on or after the date of first study medication administration in this Open-label Extension (OLE) study up to 70 days post-last dose.
Percentage of Subjects With at Least One Treatment-emergent Serious Adverse Event (SAE)
Time frame: Baseline to the end of observation period (32 weeks)
Treatment emergent SAEs are defined as SAEs starting on or after the date of first study medication administration in this OLE study up to 70 days post-last dose.

Sponsor's own description

This study will continue to evaluate the safety \& efficacy of Certolizumab Pegol (CZP) for 6 months in Chinese subjects with active Rheumatoid Arthritis who participated in RA0044.

Publications & conference data

3 peer-reviewed publications reference this trial (live from Europe PMC):

Biologics or tofacitinib for people with rheumatoid arthritis naive to methotrexate: a systematic review and network meta-analysis.
Singh JA, Hossain A, Mudano AS, Tanjong Ghogomu E, et al · · 2017 · cited 44× · PMID 28481462 · DOI 10.1002/14651858.cd012657
Biologics or tofacitinib for people with rheumatoid arthritis unsuccessfully treated with biologics: a systematic review and network meta-analysis.
Singh JA, Hossain A, Tanjong Ghogomu E, Mudano AS, et al · · 2017 · cited 38× · PMID 28282491 · DOI 10.1002/14651858.cd012591
Certolizumab pegol (CDP870) for rheumatoid arthritis in adults.
Ruiz Garcia V, Burls A, Cabello JB, Vela Casasempere P, et al · · 2017 · cited 17× · PMID 28884785 · DOI 10.1002/14651858.cd007649.pub4

Verify or expand the search:

Other trials of Certolizumab Pegol

Trials testing the same drug.

NCT07491913 — Biologic Treatment Withdrawal in Takayasu Arteritis Patients in Sustained Remission · NA · recruiting
NCT03100253 — Rheumatoid Arthritis Treatment After First Anti-TNF INvestiGation · Phase 4 · terminated
NCT03051217 — A Study to Test the Efficacy and Safety of Certolizumab Pegol in Japanese Subjects With Moderate to Severe Chronic Psori · Phase 2, PHASE3 · completed
NCT03020992 — A Study to Assess the Effects of Certolizumab Pegol on the Reduction of Anterior Uveitis (AU) Flares in Axial Spondyloar · Phase 4 · completed
NCT02346240 — Efficacy and Safety Study of Certolizumab Pegol (CZP) Versus Active Comparator and Placebo in Subjects With Plaque Psori · Phase 3 · completed

Other recruiting trials for Rheumatoid Arthritis

Currently open trials in the same condition.

NCT07433335 — A Study to Assess the Safety and Tolerability of SR-878 in Patients With Rheumatoid Arthritis · Phase 1 · recruiting
NCT07491016 — Efficacy and Safety of Telitacicept Combined With Baricitinib for Refractory Rheumatoid Arthritis · recruiting
NCT07171983 — A Study to Evaluate the Safety, Tolerability, and Drug Levels of BMS-986454 in Participants With Rheumatoid Arthritis · Phase 1 · recruiting
NCT07246096 — Exploratory Clinical Study on the Safety and Efficacy of Anti- CD19/BCMA U CAR-T Cell Injection for the Treatment of Rel · EARLY_PHASE1 · recruiting
NCT07363590 — A Clinical Study of MK-1045 in People With Lupus or Rheumatoid Arthritis (MK-1045-004) · Phase 1 · recruiting

Other UCB Pharma SA trials

Trials by the same sponsor.

NCT01832038 — Study to Evaluate the Safety, Tolerability, and Efficacy of Long-term Adjunctive Therapy With Lacosamide in Adults With · Phase 3 · completed
NCT01364597 — Open-label Long-term Study of Adjunctive Brivaracetam in Pediatric Subjects With Epilepsy · Phase 3 · completed
NCT00345800 — Exploratory Clinical Study to Evaluate Sodium Oxybate (Xyrem) on Potential Endocrine Changes · Phase 1 · completed
NCT00152503 — Study With Subjects 18-65 Years Old With Partial Onset Seizures Who Are Currently Taking Levetiracetam · Phase 2 · completed
NCT00150813 — Monotherapy With Levetiracetam in Patients Suffering From Epilepsy. · Phase 3 · completed

Verify against primary sources

ClinicalTrials.gov — authoritative US registry record
WHO ICTRP — international registry index
EU Clinical Trials Register
Sponsor press releases (Google)

Data sources for this page

Trial protocol + status: ClinicalTrials.gov NCT02319642 (US National Library of Medicine, public domain)
Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by UCB Pharma SA
Last refreshed: 15 October 2018

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT02319642.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing