A prospective, single-centre, randomised study evaluating the clinical, imaging and immunological depth of remission achieved by very early versus delayed Etanercept in patients with Rheumatoid Arthritis (VEDERA)

Table 3 Study schedule

				Arm 2^a		Arm 2^a	Arm 2^a
Study Week	Weeks -4 to 0	Week 0	Week 4	Week 8	Week 12	Week 16	Week 20	Week 24	Week 36	Week 48	Week 60	Week 72	Week 84	Week 96	Early discontinuation
Study Phase	Screen	Baseline	Safety visit							1⁰ Endpoint				End of Study
Visit No.	1	2	3	4	5	6	7	8	9	10	11	12	13	14
Informed Consent (patient information will be provided > 24 hrs prior to screen)	X
Inclusion/exclusion criteria	X	X
Randomisation		X
Demographics, RA Hx, past medical Hx, Family Hx, CV risk factors^b	X
Physical examination^c	X				X										X
Vital signs^d	X	X	X		X			X	X	X	X	X	X	X	X
Pregnancy test^e	X	X
ESR, CRP and HS-CRP	X	X	X (Arm 2 only)	X	X	X	X	X	X	X	X	X	X	X	X
Blood chemistry, haematology	X	X	X	X	X	X	X	X	X	X	X	X	X	X	X
Urinalysis	X	X	X		X			X		X		X		X	X
Serology: RF, ACPA and ANA	X													X	X
ECG	X
Chest x-ray/TB test^f	X
Hepatitis (B and C) serology	X
VAS assessments: patient general health, patient global, patient pain	X	X	X (Arm 2 only)	X	X	X	X	X	X	X	X	X	X	X	X
Physician VAS global disease activity	X	X			X			X		X		X		X	X
DAS_28/44 joint assessment^g	X	X	X (Arm 2 only)	X	X	X	X	X	X	X	X	X	X	X	X
Early morning stiffness, HAQ, RA QoL, EQ-5D, RA-WIS		X			X			X		X		X		X	X

a. Visits at weeks 8, 16 and 20 are only applicable to patients in treatment arm 2. b. Cardiovascular risk factors include: smoking habit (pack years), alcohol intake (units/week), amount of exercise taken, dietary intake (days/week ≥ 5 portions fruit or vegetables consumed), and family history of premature cardiovascular disease age <55 years. c. Physical examination Includes height and body weight at screening. d. Blood pressure after a 5-min rest, pulse rate and body temperature e. Urinary pregnancy test for women of child bearing potential only f. Chest x-ray, if not already performed within 24 weeks prior to the study. TB testing includes TB Gold Quantiferon +/- T spot test +/- Mantoux test. g. Whenever possible, joint assessments should be performed by the same blinded assessor throughout the time course of the study to reduce potential investigator bias

ISSN: 1471-2474