Condition category
Musculoskeletal Diseases
Date applied
15/02/2006
Date assigned
23/02/2006
Last edited
29/01/2015
Prospective/Retrospective
Prospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

- Dainippon Sumitomo Pharma Europe Ltd (UK) -

ORCID ID

Contact details

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

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

D2450174

Study information

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

Acronym

ASPECTS

Study hypothesis

SMP-114 in combination with methotrexate is more efficacious than methotrexate alone.

On 27/02/2007 the overall trial end date was changed from 31/03/2008 to 21/07/2008.

Ethics approval

Ethics approval received from the local medical ethics committee (UK) , 29/01/2006, ref: 05/Q0501/170

Study design

Randomised controlled trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Not specified

Trial type

Treatment

Patient information sheet

Not available in web format, please use the contact details below to request a patient information sheet

Condition

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 names

SMP-114, methotrexate

Primary outcome measures

To compare 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.

Secondary outcome measures

1. To compare 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. To compare 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

Overall trial start date

28/02/2006

Overall trial end date

21/07/2008

Reason abandoned

Eligibility

Participant inclusion criteria

1. Male or female patients aged at least 18 years, 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

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

Approximately 300 patients in total - 100 patients per arm

Participant 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

Recruitment start date

28/02/2006

Recruitment end date

13/07/2007

Locations

Countries of recruitment

Czech Republic, Germany, Hungary, Netherlands, Poland, United Kingdom

Trial participating centre

Dainippon Sumitomo Pharma Europe Ltd (UK)
London
SW1E 6QT
United Kingdom

Sponsor information

Organisation

Dainippon Sumitomo Pharma Europe Ltd (UK)

Sponsor details

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

Sponsor type

Industry

Website

Funders

Funder type

Industry

Funder name

Dainippon Sumitomo Pharma Europe Ltd (UK)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes