Assessment of safety, pharmacokinetics and efficacy in a combination treatment with SMP-114
| ISRCTN | ISRCTN32398235 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN32398235 |
| ClinicalTrials.gov number | NCT00296257 |
| Secondary identifying numbers | D2450174 |
- 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
Not provided at time of registration
Contact information
Dr Dainippon Sumitomo Pharma Europe Ltd (UK) -
Scientific
Scientific
Clinical Department
Southside
97-105 Victoria Street
London
SW1E 6QT
United Kingdom
Study information
| Study design | Randomised controlled trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Not specified |
| Study type | Treatment |
| Participant information sheet | Not available in web format, please use the contact details to request a patient 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 hypothesis | 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 |
| Condition | Rheumatoid arthritis (RA) |
| Intervention | SMP-114 (120 mg and 240 mg) in combination with methotrexate compared to methotrexate alone. |
| Intervention type | Drug |
| Pharmaceutical study type(s) | |
| Phase | Phase II |
| Drug / device / biological / vaccine name(s) | SMP-114, methotrexate |
| Primary outcome measure | 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. 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 |
| Overall study start date | 28/02/2006 |
| Overall study end date | 21/07/2008 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | Both |
| Target number of participants | Approximately 300 patients in total - 100 patients per arm |
| Participant 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 |
| 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
- England
- Germany
- Hungary
- Netherlands
- Poland
- United Kingdom
Study participating centre
Dainippon Sumitomo Pharma Europe Ltd (UK)
London
SW1E 6QT
United Kingdom
SW1E 6QT
United Kingdom
Sponsor information
Dainippon Sumitomo Pharma Europe Ltd (UK)
Industry
Industry
Southside
97-105 Victoria Street
London
SW1E 6QT
United Kingdom
"ROR" |
https://ror.org/03sh4z743 |
|---|
Funders
Funder type
Industry
Dainippon Sumitomo Pharma Europe Ltd (UK)
No information available
Results and Publications
| Intention to publish date | |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not provided at time of registration |
| Publication and dissemination plan | Not provided at time of registration |
| IPD sharing plan |
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.
