Long-term Safety and Efficacy of GSK3196165 (Otilimab) in the Treatment of Rheumatoid Arthritis (RA) (contRAst X)

JRCT ID: jRCT2080225238

Registered date:19/06/2020

Basic Information

• Recruitment status: completed
• Health condition(s) or Problem(s) studied: Rheumatoid Arthritis
• Date of first enrollment: 12/05/2020
• Target sample size: 2640
• Countries of recruitment: Argentina,Australia,Belgium,Bulgaria,Canada,China,Colombia,Czechia,Estonia,Germany,Hungary,India,Korea,Latvia,Lithuania,Malaysia,Mexico,Poland,Russian Federation,Serbia,South Africa,Spain,Thailand,Ukraine,United Kingdom,United States
• Study type: Interventional

Intervention(s)

investigational material(s)
Generic name etc :
INN of investigational material : Otilimab
Therapeutic category code : 399 Agents affecting metabolism, n.e.c.
Dosage and Administration for Investigational material :

control material(s)
Generic name etc :
INN of investigational material : -
Therapeutic category code :
Dosage and Administration for Investigational material :

Outcome(s)

Primary Outcome

safety
-Incidence of adverse events (AEs) , serious adverse events (SAEs) and adverse events of special interests (AESI) [ Time Frame: Up to 4 years ]
-Change from Baseline in platelet count, neutrophils lymphocytes, monocytes, eosinophils, and basophils (Giga cells per liter [giga cells/L]) [ Time Frame: Baseline (Day 1) and up to 4 years ]
-Proportion of participants with National Cancer Institute-Common terminology criteria for adverse events (NCI-CTCAE) more than or equal to (>=)Grade 3 hematological/clinical chemistry abnormalities [ Time Frame: Up to 4 years ]

Secondary Outcome

efficacy
-Proportion of participants achieving Clinical disease activity index (CDAI) total score less than or equal to (<=10) (CDAI Low disease activity [LDA]) at Week 24 [ Time Frame: Week 24 ]
-Proportion of participants achieving CDAI total score <=10 (CDAI LDA) at Week 48 and every 48 weeks thereafter [ Time Frame: Week 48 and every 48 weeks thereafter, up to 4 years ]
-Proportion of participants achieving CDAI total score <=2.8 (CDAI Remission) at Week 24 [ Time Frame: Week 24 ]
-Proportion of participants achieving CDAI total score <=2.8 (CDAI Remission) at Week 48 and every 48 weeks thereafter [ Time Frame: Week 48 and every 48 weeks thereafter, up to 4 years ]
-Proportion of participants achieving Disease Activity Score using 28 joint count (DAS28)-C-reactive protein (CRP) <2.6 (DAS28-CRP Remission) at Week 24 [ Time Frame: Week 24 ]
-Proportion of participants achieving DAS28-CRP <2.6 (DAS28-CRP Remission) at Week 48 and every 48 weeks thereafter [ Time Frame: Week 48 and every 48 weeks thereafter, up to 4 years ]
-Proportion of participants with DAS28- Erythrocyte sedimentation rate (ESR)<2.6 (DAS28-ESR Remission) at Week 24 [ Time Frame: Week 24 ]
-Proportion of participants with DAS28-ESR<2.6 (DAS28-ESR Remission) at Week 48 and every 48 weeks thereafter [ Time Frame: Week 48 and every 48 weeks thereafter, up to 4 years ]
-Proportion of participants achieving American College of Rheumatology (ACR) and European League Against Rheumatism (EULAR) remission (Boolean and simplified disease activity index [SDAI]) at Week 24 [ Time Frame: Week 24 ]
-Proportion of participants achieving ACR and EULAR remission (Boolean and SDAI) at Week 48 and every 48 weeks thereafter [ Time Frame: Week 48 and every 48 weeks thereafter, up to 4 years ]
-Absolute values of CDAI total score at Week 24 [ Time Frame: Week 24 ]
-Absolute values of CDAI total score at Week 48 and every 48 weeks thereafter [ Time Frame: Week 48 and every 48 weeks thereafter, up to 4 years ]
-Absolute values of DAS28-CRP at Week 24 [ Time Frame: Week 24 ]
-Absolute values of DAS28-CRP at Week 48 and every 48 weeks thereafter [ Time Frame: Week 48 and every 48 weeks thereafter, up to 4 years ]
-Absolute values of DAS28-ESR at Week 24 [ Time Frame: Week 24 ]
-Absolute values of DAS28-ESR at Week 48 and every 48 weeks thereafter [ Time Frame: Week 48 and every 48 weeks thereafter, up to 4 years ]
-Absolute values of van der Heijde modified total sharp score (mTSS) (in participants from 201790 [NCT03980483] and 201791 [NCT03970837] only) at Week 24 [ Time Frame: Week 24 ]
-Absolute values of van der Heijde mTSS (in participants from 201790 [NCT03980483] and 201791 [NCT03970837] only) at Week 48 and every 48 weeks thereafter [ Time Frame: Week 48 and every 48 weeks thereafter, up to 4 years ]
-Other secondary outcome measures

Key inclusion & exclusion criteria

• Age minimum: >= 18age old
• Age maximum: Not applicable
• Gender: Both

Include criteria

-Participants with rheumatoid arthritis who are aged >=18 years at the time of signing informed consent, who have completed one of the qualifying GSK3196165 clinical studies and who, in the opinion of the investigator, may benefit from treatment with GSK3196165.
-Body weight >=40 kilograms (kg).

Other inclusion criteria specified protocol may also be followed.

Exclude criteria

-Had study intervention permanently discontinued at any time during a qualifying study.
-Were temporarily discontinued from study intervention at the time of the final study visit of a qualifying study and, in the opinion of the investigator, participation in the extension study poses an unacceptable risk for the participant's participation.

Other exclusion criteria specified protocol may also be followed.

Related Information

• Primary Sponsor: GlaxoSmithKline K.K.
• Secondary ID(s): NCT04333147,JapicCTI-205334