Management of Musculoskeletal Manifestations in Inflammatory Bowel Disease

Table 3

Ongoing clinical trials with biosimilars in participants with IBD or inflammatory arthritis.

Parent drug	Biosimilar agent	Sponsor	Condition	Trial description	ClinicalTrials.gov identifier	Status	Phase
IFX	CT-P13	Celltrion	AS	An extension study to demonstrate the equivalence of long-term efficacy and safety of CT-P13 in patients with ankylosing spondylitis who were treated with infliximab (Remicade or CT-P13) in study CT-P13 1.1	NCT01571206	COM	1
IFX	CT-P13	Celltrion	RA	An extension study to demonstrate long-term efficacy and safety of CT-P13 when coadministered with methotrexate in patient With rheumatoid arthritis who were treated with infliximab (Remicade or CT-P13) in study CT-P13 3.1	NCT01571219	COM	3
IFX	CT-P13	Celltrion	CD	Demonstrate noninferiority in efficacy and to assess safety of CT-P13 in patients with active Crohn’s disease	NCT02096861	REC	3
IFX	CT-P13	Celltrion	AS	Program evaLuating the Autoimmune disease iNvEstigational drug cT-p13 in AS patients (PLANETAS)	NCT01220518	COM	1
IFX	CT-P13	Celltrion	RA	Program evaLuating the Autoimmune disease iNvEstigational drug cT-p13 in RA patients (PLANETRA)	NCT01217086	COM	3
IFX	IFX biosimilar	Diakonhjemmet Hospital	RA; AS; PsA; UC; CD	A randomized, double-blind, parallel-group study to evaluate the safety and efficacy of switching from innovator infliximab to biosimilar infliximab compared with continued treatment with innovator infliximab in patients with rheumatoid arthritis, spondyloarthritis, psoriatic arthritis, ulcerative colitis, Crohn’s disease and chronic plaque psoriasis the nor-switch study	NCT02148640	REC	4
IFX	SB-2	Samsung Bioepis	RA	A study comparing SB2 to Remicade in subjects with moderate to severe rheumatoid arthritis despite methotrexate therapy	NCT01936181	ONG	3
ETA	SB-4	Samsung Bioepis	RA	A study comparing SB4 to Enbrel in subjects with moderate to severe rheumatoid arthritis despite methotrexate therapy	NCT01895309	ONG	3
ETA	CHS-0214	Coherus	RA	Comparison of CHS-0214 to Enbrel (etanercept) in patients with rheumatoid arthritis (RA) (CHS-0214-02)	NCT02115750	REC	3
RTX	CT-P10	Celltrion	RA	Demonstrate the equivalence of CT-P10 to MabThera with respect to the pharmacokinetic profile in patients with rheumatoid arthritis (Triad RA)	NCT01534884	ONG	1
RTX	BCD-020	Biocad	RA	Study of safety and efficacy of BCD-020 comparing to MabThera in patients with rheumatoid arthritis (BIORA)	NCT01759030	ONG	3
RTX	CT-P10	Celltrion	RA	Long-term efficacy and safety of CT-P10 in patients with RA	NCT01873443	ONG	1

Data are from http://clinicaltrials.gov/.
Data are current as of April 17, 2015.
IFX: infliximab, ETA: etanercept, RTA: rituximab, RA: rheumatoid arthritis, AS: ankylosing spondylitis, CD: Crohn’s disease, PsA: psoriatic arthritis.
Trial status: COM completed, REC recruiting, ONG trial is ongoing, but not recruiting participants; NYR trial is registered but not yet recruiting participants.