Assessment of safety, pharmacokinetics and efficacy in a combination treatment with SMP-114

ISRCTN	ISRCTN32398235
DOI	https://doi.org/10.1186/ISRCTN32398235
ClinicalTrials.gov (NCT)	NCT00296257
Protocol serial number	D2450174
Sponsor	Dainippon Sumitomo Pharma Europe Ltd (UK)
Funder	Dainippon Sumitomo Pharma Europe Ltd (UK)

Submission date: 15/02/2006
Registration date: 23/02/2006
Last edited: 10/09/2019

Recruitment status: Stopped
Overall study status: Stopped
Condition category: Musculoskeletal Diseases

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Record updated in last year

Plain English summary of protocol

Not provided at time of registration

Contact information

Dr Dainippon Sumitomo Pharma Europe Ltd (UK) -
Scientific

Clinical Department
Southside
97-105 Victoria Street
London
SW1E 6QT
United Kingdom

Study information

Primary study design	Interventional
Study design	Randomised controlled trial
Secondary study design	Randomised controlled trial
Study type	Participant information sheet
Scientific title	A phase II, multicentre, randomised, double-blind, placebo-controlled study evaluating the efficacy, safety and pharmacokinetics of two doses of a candidate disease modifying anti-rheumatic drug (DMARD) (SMP-114, 120 mg and 240 mg once daily) administered in combination with ongoing methotrexate treatment in patients with active rheumatoid arthritis
Study acronym	ASPECTS
Study objectives	SMP-114 in combination with methotrexate is more efficacious than methotrexate alone.
Ethics approval(s)	Local medical ethics committee (UK) , 29/01/2006, ref: 05/Q0501/170
Health condition(s) or problem(s) studied	Rheumatoid arthritis (RA)
Intervention	SMP-114 (120 mg and 240 mg) in combination with methotrexate compared to methotrexate alone.
Intervention type	Drug
Phase	Phase II
Drug / device / biological / vaccine name(s)	SMP-114, methotrexate
Primary outcome measure(s)	The efficacy of SMP-114 (120 mg and 240 mg) versus placebo in terms of the percentage of patients meeting the ACR criteria for 20% improvement in RA (ACR20) at week 24.
Key secondary outcome measure(s)	1. The efficacy of SMP-114 (120 mg and 240 mg) versus placebo after 24 weeks in terms of: 1.1. ACR50 1.2. ACR70 1.3. Disease Activity Score-28 (DAS28) 1.4. European League Against Rheumatism (EULAR) response 2. The efficacy of SMP-114 versus placebo in terms of change in: 2.1. Core variables 2.2. Time to response 2.3. Quality of life 2.4. Radiological measurements of joint damage 2.5. Assessment of safety and tolerability 2.6. Pharmacokinetics (PK) measurements
Completion date	21/07/2008

Eligibility

Participant type(s)	Patient
Age group	Adult
Lower age limit	18 Years
Sex	All
Target sample size at registration	300
Key inclusion criteria	1. Male or female patients aged at least 18, with rheumatoid arthritis (RA) for a minimum of six months 2. Has been receiving methotrexate treatment (stable for eight weeks) 3. Has active disease classified as American College of Rheumatology (ACR) functional class of I, II or III
Key exclusion criteria	1. Has previously discontinued DMARD therapy due to hepatic intolerance 2. Has received any DMARD in addition to methotrexate during the four weeks prior to randomisation 3. Is receiving more than two DMARDs in addition to methotrexate at the time of screening 4. Is receiving or has received gold, leflunomide or biological agents including tumour necrosis factor (TNF) or Interleukin 1 (IL-1) inhibitors within the eight weeks prior to randomisation 5. Has previously failed two or more DMARDS
Date of first enrolment	28/02/2006
Date of final enrolment	13/07/2007

Locations

Countries of recruitment

United Kingdom
England
Czech Republic
Germany
Hungary
Netherlands
Poland

Study participating centre

Dainippon Sumitomo Pharma Europe Ltd (UK)

London
SW1E 6QT
United Kingdom

Results and Publications

Individual participant data (IPD) Intention to share	No
IPD sharing plan summary
IPD sharing plan

Study outputs

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
Participant information sheet	Participant information sheet	11/11/2025	11/11/2025	No	Yes

Editorial Notes

10/09/2019: ClinicalTrials.gov number added. ClinicalTrials.gov stated that this trial was terminated.
07/06/2017: No publications found, verifying study status with principal investigator.
27/02/2007: The overall trial end date was changed from 31/03/2008 to 21/07/2008.