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NCT00686868
Study to Evaluate SC Route of Administration of Ofatumumab in RA Patients
Phase 1 trial testing placebo in Arthritis, Rheumatoid in 35 participants. Completed in 2 May 2011.
11 March 2011
Quick facts
| Lead sponsor | GlaxoSmithKline |
|---|---|
| Phase | Phase 1 |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | parallel |
| Masking | single |
| Primary purpose | treatment |
| Enrollment | 35 |
| Start date | 13 June 2008 |
| Primary completion | 11 March 2011 |
| Estimated completion | 2 May 2011 |
| Sites | 17 locations across France, Italy, New Zealand, Russia, Belgium, Poland, Australia, United States |
Drugs / interventions tested
- placebo
- ofatumumab (OFATUMUMAB) — full drug profile →
Conditions studied
- Arthritis, Rheumatoid — all drugs for Arthritis, Rheumatoid →
Sponsor
GlaxoSmithKline — full company profile →
Who can join
18 and older, any sex, with Arthritis, Rheumatoid. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
This study will examine the safety and tolerability, PK and PD of subcutaneously administered GSK1841157 in patients with RA on stable dose Methotrexate. The study comprises a single dose escalation/de-escalation phase to investigate the minimal efficacious dose based on PD markers with an acceptable safety profile.
Publications & conference data
5 peer-reviewed publications reference this trial (live from Europe PMC):
-
Next-generation anti-CD20 monoclonal antibodies in autoimmune disease treatment.
Du FH, Mills EA, Mao-Draayer Y. · · 2017 · cited 120× · PMID 29143151 · DOI 10.1007/s13317-017-0100-y -
Ofatumumab.
Zhang B. · · 2009 · cited 55× · PMID 20068404 · DOI 10.4161/mabs.1.4.8895 -
Biologics or tofacitinib for people with rheumatoid arthritis naive to methotrexate: a systematic review and network meta-analysis.
Singh JA, Hossain A, Mudano AS, Tanjong Ghogomu E, et al · · 2017 · cited 44× · PMID 28481462 · DOI 10.1002/14651858.cd012657 -
Biologics or tofacitinib for people with rheumatoid arthritis unsuccessfully treated with biologics: a systematic review and network meta-analysis.
Singh JA, Hossain A, Tanjong Ghogomu E, Mudano AS, et al · · 2017 · cited 38× · PMID 28282491 · DOI 10.1002/14651858.cd012591 -
Subcutaneously administered ofatumumab in rheumatoid arthritis: a phase I/II study of safety, tolerability, pharmacokinetics, and pharmacodynamics.
Kurrasch R, Brown JC, Chu M, Craigen J, et al · · 2013 · cited 32× · PMID 23729801 · DOI 10.3899/jrheum.121118
Verify or expand the search:
- PubMed search for NCT00686868
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
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Other recruiting trials for Arthritis, Rheumatoid
Currently open trials in the same condition.
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- NCT06528431 — Design and Evaluation of an Individualized Biodrug Tapering Strategy Based on Biodrug Dosage: the MONITORA Study · Phase 4 · recruiting
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Other GlaxoSmithKline trials
Trials by the same sponsor.
- NCT07569081 — A Study Evaluating the Efficacy and Safety of Momelotinib in Participants With Vacuoles, E1-enzyme, X-linked, Autoinflam · Phase 2, PHASE3 · not yet recruiting
- NCT07406347 — A Trial to Evaluate the Safety and Reactogenicity of an Investigational Pneumococcal Vaccine in Infants Receiving 3-dose · Phase 1 · not yet recruiting
- NCT07286266 — A Study to Investigate GSK5733584 Compared With Chemotherapy in Participants With Platinum-resistant Ovarian Cancer (BEH · Phase 3 · not yet recruiting
- NCT07286331 — A Study to Investigate GSK5733584 Compared With Chemotherapy in Participants With Recurrent Endometrial Cancer (BEHOLD-E · Phase 3 · not yet recruiting
- NCT07406334 — A Trial to Evaluate the Safety and Reactogenicity of an Investigational Pneumococcal Vaccine in Toddlers 12 to 15 Months · Phase 1 · not yet recruiting
Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT00686868 (US National Library of Medicine, public domain)
- Publications: Europe PMC API search by NCT ID, retrieved 9 June 2026
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by GlaxoSmithKline
- Last refreshed: 26 June 2017
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT00686868.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing