WHO ICTRP trial
A PHASE 3B/4 STUDY OF METHOTREXATE (MTX) WITHDRAWAL IN SUBJECTS WITH RHEUMATOID…
EUCTR2016-001825-15-BE · EU Clinical Trials Register · Not Recruiting
Key facts
| Trial ID | EUCTR2016-001825-15-BE |
|---|---|
| Public title | A PHASE 3B/4 STUDY OF METHOTREXATE (MTX) WITHDRAWAL IN SUBJECTS WITH RHEUMATOID ARTHRITIS (RA) TREATED WITH TOFACITINIB 11MG |
| Scientific title | A PHASE 3B/4 RANDOMIZED DOUBLE BLIND PLACEBO CONTROLLED STUDY OF METHOTREXATE (MTX) WITHDRAWAL IN SUBJECTS WITH RHEUMATOID ARTHRITIS (RA) TREATED WITH TOFACITINIB 11MG MODIFIED RELEASE (MR) FORMULATION |
| Primary sponsor | Pfizer Inc., 235 East 42nd Street, New York, New York |
| Registry | EU Clinical Trials Register |
| Recruitment status | Not Recruiting |
| Study type | Interventional clinical trial of medicinal product |
| Phase | Human pharmacology (Phase I): no Therapeutic exploratory (Phase II): no Therapeutic confirmatory - (Phase III): yes Therapeutic use (Phase IV): yes |
| Countries | United States;Philippines;Slovakia;Spain;Russian Federation;Italy;United Kingdom;Czech Republic;Hungary;Mexico;Poland;Belgium;Australia;South Africa;Bulgaria;Germany;Korea, Republic of |
| Conditions | Rheumatoid Arthritis MedDRA version: 20.0 Level: PT Classification code 10039073 Term: Rheumatoid arthritis System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders ;Therapeutic area: Diseases [C] - Immune System… |
| Interventions | Product Name: tofacitinib Product Code: CP 690,550 Pharmaceutical Form: Modified-release tablet INN or Proposed INN: tofacitinib CAS Number: 540737-29-9 Current Sponsor code: CP 690,550 Other descriptive name: TOFACITINIB CITRATE… |
| Registration date | Feb 28, 2017 |
| Target size | 680 |
| Secondary IDs | A3921192;NCT02831855;2016-001825-15-SK |
| Registry page | clinicaltrialsregister.eu |
At a glance
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About WHO ICTRP trial registrations
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Source: World Health Organization (WHO), International Clinical Trials Registry Platform (ICTRP) · Source date: