Last updated: 11/07/2018 12:19:08
Meta-analysis of clinical efficacy studies of licensed Rheumatoid Arthritis (RA) treatments
Clinicaltrials.gov ID
Not applicable
EudraCT ID
Not applicable
EU CT Number
Not applicable
Trial status
Study complete
Study complete
Trial overview
Official title: Meta-analysis of clinical efficacy studies of licensed Rheumatoid Arthritis (RA) treatments
Trial description: This is a meta-analysis of clinical efficacy studies of biologics currently licensed for the treatment of rheumatoid arthritis.
Primary purpose:
Not applicable
Trial design:
Not applicable
Masking:
Not applicable
Allocation:
Not applicable
Primary outcomes:
Disease Activity Score 28 (DAS28)
Timeframe: At 26, 52 weeks and >18 months
American College of Rheumatology (ACR) 20/50/70 criteria
Timeframe: At 26, 52 weeks and >18 months
European League Against Rheumatism (EULAR) response
Timeframe: At 26, 52 weeks and >18 months
Secondary outcomes:
swollen and tender joints counts
Timeframe: At 26, 52 weeks and >18 months
Pain Visual Analogue Scale (VAS)
Timeframe: At 26, 52 weeks and >18 months
Adverse events
Timeframe: At 26, 52 weeks and >18 months
Functional Assessment of Chronic Illness Therapy (FACIT) -Fatigue
Timeframe: At 26, 52 weeks and >18 months
Sharp score
Timeframe: At 26, 52 weeks and >18 months
Health Assessment Questionnaire (HAQ)
Timeframe: At 26, 52 weeks and >18 months
Mortality
Timeframe: At 26, 52 weeks and >18 months
Health Related Quality of Life (HRQoL)
Timeframe: At 26, 52 weeks and >18 months
Interventions:
Enrollment:
1
Primary completion date:
Not applicable
Observational study model:
Other
Time perspective:
Retrospective
Clinical publications:
Rafael Alfonso-Cristancho, Nigel Armstrong, Ramesh Arjunji, Rob Riemsma, Gill Worthy, Rita Ganguly, Jos Kleijnen. Comparative effectiveness of biologics for the management of rheumatoid arthritis: systematic review and network meta-analysis. Clin Rheumatol. 2017;36(1):25-34.
Medical condition
Arthritis, Rheumatoid
Product
sirukumab
Collaborators
Not applicable
Study date(s)
May 2014 to June 2014
Type
Observational
Phase
Not applicable
Participation criteria
Sex
Female & Male
Age
18 - 100 Year
Accepts healthy volunteers
none
- Adults with RA who have failed on previous treatment with conventional DMARDs
- Adults with RA who have failed on previous treatment with biological DMARDs
Inclusion and exclusion criteria
Inclusion criteria:
- Adults with RA who have failed on previous treatment with conventional DMARDs
- Adults with RA who have failed on previous treatment with biological DMARDs
- Adults with RA who are refractory or intolerant to anti-TNF-α agents or other DMARDs
Trial location(s)
This study does not involve prospective enrollment of participants.
Study documents
Scientific result summary
Available language(s): English
Protocol
Available language(s): English
If you wish to request for full study report, please contact - [email protected]
Results overview
Refer to study documents
Recruitment status
Study complete
Actual primary completion date
Not applicable
Actual study completion date
2014-16-06
Plain language summaries
Not applicable. GSK’s transparency policy provides for Plain Language Summaries for Interventional studies.
Additional information about the trial
Not applicable
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